Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS... | NCT04426695 | Trialant
NCT04426695
Sponsor
Regeneron Pharmaceuticals
Status
Completed
Last Update Posted
Jan 27, 2023Actual
Enrollment
2,252Actual
Phase
Phase 1Phase 2
Conditions
COVID-19
Interventions
REGN10933+REGN10987 combination therapy
Placebo
Countries
United States
Brazil
Chile
Mexico
Moldova
Romania
Protocol Section
Identification Module
NCT ID
NCT04426695
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
R10933-10987-COV-2066
Secondary IDs
ID
Type
Description
Link
2020-002537-15
EudraCT Number
Brief Title
Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19
Official Title
A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Hospitalized Patients With COVID-19
Acronym
Not provided
Organization
Regeneron PharmaceuticalsINDUSTRY
Status Module
Record Verification Date
Jan 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 10, 2020Actual
Primary Completion Date
May 7, 2021Actual
Completion Date
Oct 22, 2021Actual
First Submitted Date
Jun 8, 2020
First Submission Date that Met QC Criteria
Jun 10, 2020
First Posted Date
Jun 11, 2020Actual
Results Waived
Not provided
Results First Submitted Date
May 5, 2022
Results First Submitted that Met QC Criteria
Jun 28, 2022
Results First Posted Date
Jul 25, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 25, 2023
Last Update Posted Date
Jan 27, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Regeneron PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary objectives are:
Pooled Phase 3 (Cohort 1) and Phase 2 (Cohort 1A)
To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2
To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation
Phase 1/2 (Cohort 1)
To exclude futility of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation
To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo
Detailed Description
Not provided
Conditions Module
Conditions
COVID-19
Keywords
Coronavirus disease 2019 (COVID-19)
Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2)
coronavirus
acute respiratory distress syndrome
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
2,252Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
On Low-Flow Oxygen
Experimental
Cohort 1 (C1): O2 saturation >93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device
Drug: REGN10933+REGN10987 combination therapy
Drug: Placebo
With COVID-19 symptoms but not requiring supplemental O2
Experimental
Cohort 1A (C1A): With COVID-19 symptoms but not requiring supplemental oxygen
Drug: REGN10933+REGN10987 combination therapy
Drug: Placebo
High O2 No Mechanical Ventilation
Experimental
Cohort 2 (C2): On high-intensity oxygen (O2) therapy but not on mechanical ventilation
Drug: REGN10933+REGN10987 combination therapy
Drug: Placebo
On Mechanical Ventilation
Experimental
Cohort 3 (C3): On mechanical ventilation
Drug: REGN10933+REGN10987 combination therapy
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
REGN10933+REGN10987 combination therapy
Drug
Administered intravenously (IV) single dose
High O2 No Mechanical Ventilation
On Low-Flow Oxygen
On Mechanical Ventilation
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Based on Seronegative mFAS
Time-weighted average daily change from Day 1 to Day 7 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.
Day 1 to Day 7
Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on High Viral Load mFAS
Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on high viral load mFAS were reported.
Day 6 to Day 29
Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Seronegative mFAS
Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on seronegative mFAS were reported.
Day 6 to Day 29
Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Overall mFAS
Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on overall FAS were reported.
Day 6 to Day 29
Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on High Viral Load mFAS
Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on high viral load mFAS were reported.
Secondary Outcomes
Measure
Description
Time Frame
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS
Percentage of participants who went on mechanical ventilation by Day 29 based on High Viral Load mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.
by Day 29
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Has SARS-CoV-2-positive antigen or molecular diagnostic test (by validated SARS-CoV-2 antigen, RT-PCR, or other molecular diagnostic assay, using an appropriate sample such as NP, nasal, oropharyngeal [OP], or saliva) ≤72 hours prior to randomization and no alternative explanation for current clinical condition. A historical record of positive result from test conducted ≤72 hours prior to randomization is acceptable.
Has symptoms consistent with COVID-19, as determined by investigator, with onset ≤10 days before randomization
Hospitalized for ≤72 hours with at least 1 of the following at randomization; patients meeting more than one criterion will be categorized in the most severely affected category:
Cohort 1A: With COVID-19 symptoms but not requiring supplemental oxygen
Cohort 1: Maintains O2 saturation >93% on low-flow oxygen as defined in the protocol
Cohort 2: High-intensity oxygen therapy without mechanical ventilation as defined in the protocol
Cohort 3: On mechanical ventilation
Key Exclusion Criteria:
Phase 1 Only: Patients maintaining O2 saturation >94% on room air
In the opinion of the investigator, unlikely to survive for >48 hours from screening
Somersan-Karakaya S, Mylonakis E, Mou J, Oviedo-Orta E, O'Brien MP, Mas Casullo V, Mahmood A, Hooper AT, Hussein M, Ali S, Marty FM, Forleo-Neto E, Bhore R, Hamilton JD, Herman GA, Hirshberg B, Weinreich DM. Effectiveness of Casirivimab and Imdevimab Antibody Combination in Immunocompromised Hospitalized Patients With Coronavirus Disease 2019: A Post Hoc Analysis in a Phase 1/2/3 Double-Blind Trial. Open Forum Infect Dis. 2023 Apr 19;10(5):ofad211. doi: 10.1093/ofid/ofad211. eCollection 2023 May.
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame
Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification
Access Criteria
Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
A total of 2324 participants were screened and 2203 participants randomized and treated, 49 participants were randomized but not treated, and 72 discontinued at the screening phase. Reasons for discontinuation at screening phase: 54 - Screen Failure, 10 - Subject Decision, 1- Sponsor Request, 7- Other.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Phase 1: Cohort 1 (Placebo)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 1 (Cohort 1).
With COVID-19 symptoms but not requiring supplemental O2
REGN-COV2
REGEN-COV™
Ronapreve™
casirivimab
imdevimab
Placebo
Drug
Placebo IV Single Dose
High O2 No Mechanical Ventilation
On Low-Flow Oxygen
On Mechanical Ventilation
With COVID-19 symptoms but not requiring supplemental O2
Day 1 to Day 29
Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Seronegative mFAS
Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on seronegative mFAS were reported.
Day 1 to Day 29
Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Overall mFAS
Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on overall mFAS were reported.
Day 1 to Day 29
Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Treatment-Emergent Serious Adverse Events
Treatment-emergent adverse events are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the observation period.
Up to Day 169
Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade >=2 Infusion Related Reactions up to Day 4
Infusion-related reactions are defined as any relevant adverse event that occurs during the infusion or up to day 4. The severity of adverse events (including test findings classified as adverse events) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).
Up to Day 4
Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade >=2 Hypersensitivity Reactions Up to Day 29
Hypersensitivity reactions are defined as any relevant adverse event that occurs during the infusion or up to study day 29. The severity of adverse events (including test findings classified as adverse events) were graded according to NCI-CTCAE.
Up to Day 29
Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on Seronegative mFAS
Cumulative incidence percentage was estimated using Kaplan-Meier method.
Up to Day 29
Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on High Viral Load mFAS
Cumulative incidence percentage was estimated using Kaplan-Meier method.
Up to Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS
Percentage of participants who went on mechanical ventilation at Day 29 based on Seronegative mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.
by Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on High Viral Load mFAS
Percentage of participants who died from Day 6 through Day 29 based on high viral load mFAS were reported.
Day 6 to Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS
Percentage of participants who died from Day 6 through Day 29 Based on seronegative mFAS in pooled analysis phase 3 (cohort 1) and phase 2 (cohort 1A) were reported.
Day 6 to Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on High Viral Load mFAS
Percentage of participants who died from Day 1 through Day 29 based on High Viral Load mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.
Day 1 to Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS
Percentage of participants who died from Day 1 through Day 29 based on seronegative mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.
Day 1 to Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS
Percentage of participants who were discharged by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported.
by Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS
Percentage of participants who were discharged by Day 29 based on seronegative mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported.
by Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS
Percentage of participants who died or were readmitted to hospital over time based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A)were reported. Readmission to hospital was based on investigator report.
Up to Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS
Percentage of participants who died or were readmitted to hospital at Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Readmission to hospital was based on investigator report.
by Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on High Viral Load mFAS
Overall Survival was defined as time interval from randomization to death. Percentage of participants with cumulative incidence of death (ie, overall survival) at Day 29 from randomization based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
by Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on Seronegative mFAS
Overall Survival was defined as time interval from randomization to death. Percentage of participants with cumulative incidence of death (ie, overall survival) at Day 29 from randomization based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A)were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
by Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on High Viral Load mFAS
Number of participants with cumulative incidence of mechanical ventilation by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
by Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS
Percentage of participants with cumulative incidence of mechanical ventilation by Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
by Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on High Viral Load mFAS
Percentage of participants with cumulative incidence of death or mechanical ventilation by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
by Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS
Percentage of participants with cumulative incidence of death or mechanical ventilation by Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
by Day 29
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on High Viral Load mFAS
Time to discharge from hospital based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) was reported.
Up to Day 56
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS
Time to discharge from hospital based on Seronegative mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) was reported.
Up to Day 56
Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Treatment-Emergent Serious Adverse Events
Up to Day 169
Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade >=2 Infusion Related Reactions up to Day 4
Up to Day 4
Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade >=2 Hypersensitivity Reactions Up to Day 29
Up to Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS
Percentage of participants who went on mechanical ventilation in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.
by Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS
Percentage of participants who died from Day 6 through Day 29 in phase 3 (cohort 1) and phase 2 (cohort 1A) were reported.
Day 6 to Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS
Percentage of participants who died from Day 1 through Day 29 in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.
Day 1 to Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS
Percentage of participants who were discharged in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported.
by Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS
Percentage of participants who died or were readmitted to hospital in phase 3 (Cohort 1) and phase 2 (Cohort 1A) by Day 29 were reported. Readmission to hospital was based on investigator report.
Up to Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death up to Day 29 Based on Seronegative mFAS
Percentage of participants with cumulative incidence of death in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) up to Day 29 from randomization were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
Up to Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS
Percentage of participants with cumulative incidence of mechanical ventilation in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
by Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS
Percentage of participants with cumulative incidence of death or mechanical ventilation in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
by Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS
Time to discharge from hospital up to Day 56 was reported.
Up to Day 56
Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 11 Based on Seronegative mFAS
TWA change from baseline in viral load up to Day 11 was calculated for each participant using the trapezoidal rule as the area under the curve for change from baseline at each time point divided by the time interval for the observation period. TWA change from baseline viral load in NP samples through Day 11, was measured by RT-qPCR in NP swab samples was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicate improvement in viral load.
Day 1 to Day 11
Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 29
TWA change from baseline in viral load up to Day 29 was calculated for each participant using the trapezoidal rule as the area under the curve for change from baseline at each time point divided by the time interval for the observation period. TWA change from baseline viral load in NP samples through Day 29, was measured by quantitative RT-qPCR in NP swab samples was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicate improvement in viral load.
Day 1 to Day 29
Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time
Change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.
Days 3, 5, 7, 9, 11, 13, 15, 22 and 29
Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time
Percent change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.
Days 3, 5, 7, 9, 11, 13, 15, 22 and 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS
Percentage of participants who went on mechanical ventilation in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.
by Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 to Day 29 Based on High Viral Load mFAS
Percentage of participants who died in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.
Day 6 to Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 to Day 29 Based on High Viral Load mFAS
Percentage of participants who died in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.
Day 1 to Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS
Percentage of participants who were discharged in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.
by Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS
Percentage of participants who died or were readmitted to hospital in phase 3 (Cohort 1) and phase 2 (Cohort 1A) over time were reported. Readmission to hospital was based on investigator report.
Up to Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death Over Time Based on High Viral Load mFAS
Cumulative Incidence of Death Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
Up to Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation Over Time Based on High Viral Load mFAS
Cumulative Incidence of Mechanical Ventilation Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
Up to Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation Over Time Based on High Viral Load mFAS
Cumulative Incidence of Death or Mechanical Ventilation Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
Up to Day 29
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge Based on High Viral Load mFAS
Time to Discharge in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.
Up to Day 56
Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS
Time-weighted average daily change over time up to Day 29 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.
Up to Day 29
Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS
Change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.
Days 3, 5, 7, 9, 11, 13, 15, 22 and 29
Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on Seronegative mFAS
Through Day 29
Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on High Viral Load mFAS
Through Day 29
Phase 1 [Cohort 1]: Area Under the Concentration-Time Curve From Time 0 to 28 Days Post-dose (AUC0-28)
Up to Day 28
Concentration at the End of Infusion (Ceoi)
Day 1
Concentration at Day 28 (C28)
Day 28
Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933
Through Day 169
Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987
Through Day 169
Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10933
Through Day 57
Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10987
Through Day 57
Chandler
Arizona
85224
United States
Regeneron Study Site
Phoenix
Arizona
85006
United States
Regeneron Study Site 1
Tucson
Arizona
85724
United States
Regeneron Study Site
Long Beach
California
90806
United States
Regeneron Study Site
Mission Hills
California
91345
United States
Regeneron Study Site
Sacramento
California
95817
United States
Regeneron Study Site
Santa Monica
California
90404
United States
Regeneron Study Site
Stanford
California
94305
United States
Regeneron Study Site
Aurora
Colorado
80045
United States
Regeneron Study Site
Boca Raton
Florida
33486
United States
Regeneron Study Site
Ft. Pierce
Florida
34982
United States
Regeneron Study Site
Gainesville
Florida
32610
United States
Regeneron Study Site
Orlando
Florida
32803
United States
Regeneron Study Site
Pensacola
Florida
32504
United States
Regeneron Study Site
Sarasota
Florida
34239
United States
Regeneron Study Site
Tampa
Florida
33612
United States
Regeneron Study Site
Atlanta
Georgia
30309
United States
Regeneron Study Site
Atlanta
Georgia
30322
United States
Regeneron Study Site
Augusta
Georgia
30912
United States
Regeneron Study Site
Marietta
Georgia
30060
United States
Regeneron Study Site
Chicago
Illinois
60611
United States
Regeneron Study Site
Chicago
Illinois
60612
United States
Regeneron Study Site
Glenview
Illinois
60026
United States
Regeneron Study Site
Urbana
Illinois
61801
United States
Regeneron Study Site
Indianapolis
Indiana
46260
United States
Regeneron Study Site
Iowa City
Iowa
52242
United States
Regeneron Study Site
Louisville
Kentucky
40202
United States
Regeneron Study Site
Louisville
Kentucky
40217
United States
Regeneron Study Site
New Orleans
Louisiana
70112
United States
Regeneron Study Site
New Orleans
Louisiana
70122
United States
Regeneron Study Site
Baltimore
Maryland
21201
United States
Regeneron Study Site
Boston
Massachusetts
02111
United States
Regeneron Study Site
Boston
Massachusetts
02115
United States
Regeneron Study Site
Boston
Massachusetts
02118
United States
Regeneron Study Site
Grand Rapids
Michigan
49503
United States
Regeneron Study Site
Royal Oak
Michigan
48073
United States
Regeneron Study Site
Rochester
Minnesota
55905
United States
Regeneron Study Site
Chesterfield
Missouri
63017
United States
Regeneron Study Site
St Louis
Missouri
63104
United States
Regeneron Study Site
St Louis
Missouri
63110
United States
Regeneron Study Site
Omaha
Nebraska
68198-5400
United States
Regeneron Study Site
Las Vegas
Nevada
89109
United States
Regeneron Study Site
Englewood
New Jersey
07631
United States
Regeneron Study Site
Hackensack
New Jersey
07601
United States
Regeneron Study Site
Morristown
New Jersey
07960
United States
Regeneron Study Site
Neptune City
New Jersey
07753
United States
Regeneron Study Site
Pennington
New Jersey
08534
United States
Regeneron Study Site
Summit
New Jersey
07901
United States
Regeneron Study Site
Teaneck
New Jersey
07666
United States
Regeneron Study Site
Albuquerque
New Mexico
87108
United States
Regeneron Study Site
Brooklyn
New York
11219
United States
Regeneron Study Site
Buffalo
New York
14203
United States
Regeneron Study Site 1
Buffalo
New York
14215
United States
Regeneron Study Site 2
Buffalo
New York
14215
United States
Regeneron Study Site
Jamaica
New York
11432
United States
Regeneron Study Site
New York
New York
10003
United States
Regeneron Study Site
New York
New York
10019
United States
Regeneron Study Site
New York
New York
10025
United States
Regeneron Study Site
New York
New York
10029
United States
Regeneron Study Site
New York
New York
10032
United States
Regeneron Study Site
New York
New York
10037
United States
Regeneron Study Site
Rochester
New York
14642
United States
Regeneron Study Site
Syracuse
New York
13210
United States
Regeneron Study Site
The Bronx
New York
10451
United States
Regeneron Study Site
The Bronx
New York
10461
United States
Regeneron Study Site
West Islip
New York
11795
United States
Regeneron Study Site
White Plains
New York
10601
United States
Regeneron Study Site
Chapel Hill
North Carolina
27599
United States
Regeneron Study Site
Greensboro
North Carolina
27408
United States
Regeneron Study Site
Columbus
Ohio
43210
United States
Regeneron Study Site
Columbus
Ohio
43215
United States
Regeneron Study Site
Dayton
Ohio
45409
United States
Regeneron Study Site
Portland
Oregon
97213
United States
Regeneron Study Site
Portland
Oregon
97239
United States
Regeneron Study Site
Philadelphia
Pennsylvania
19140
United States
Regeneron Study Site
Providence
Rhode Island
02903
United States
Regeneron Study Site
Providence
Rhode Island
02906
United States
Regeneron Study Site
Sioux Falls
South Dakota
57108
United States
Regeneron Study Site 1
Amarillo
Texas
79106
United States
Regeneron Study Site 2
Amarillo
Texas
79106
United States
Regeneron Study Site
Dallas
Texas
75235
United States
Regeneron Study Site
Dallas
Texas
75246
United States
Regeneron Study Site
Dallas
Texas
75390
United States
Regeneron Study Site
Houston
Texas
77004
United States
Regeneron Study Site
Houston
Texas
77024
United States
Regeneron Study Site
Houston
Texas
77030
United States
Regeneron Study Site
Lubbock
Texas
79410
United States
Regeneron Study Site
Sugar Land
Texas
77479
United States
Regeneron Study Site
Tyler
Texas
75701
United States
Regeneron Study Site
Murray
Utah
84107
United States
Regeneron Study Site
Salt Lake City
Utah
84143
United States
Regeneron Study Site
Richmond
Virginia
23298
United States
Regeneron Study Site
Everett
Washington
98201
United States
Regeneron Study Site 1
Seattle
Washington
98122
United States
Regeneron Study Site
Madison
Wisconsin
53792
United States
Regeneron Study Site
Fortaleza
Ceará
60160-230
Brazil
Regeneron Study Site
Salvador
Estado de Bahia
40170-130
Brazil
Regeneron Study Site
Curitiba
Paraná
80810-040
Brazil
Regeneron Study Site
Passo Fundo
Rio Grande do Sul
99010-170
Brazil
Regeneron Study Site
Porto Alegre
Rio Grande do Sul
90610-000
Brazil
Regeneron Study Site
Chapecó
Santa Catarina
89801-355
Brazil
Regeneron Study Site
Criciúma
Santa Catarina
88811-508
Brazil
Regeneron Study Site
Botucatu
São Paulo
18618-686
Brazil
Regeneron Study Site
Campinas
São Paulo
13060-080
Brazil
Regeneron Study Site
São Paulo
02401- 400
Brazil
Regeneron Study Site
São Paulo
04012-909
Brazil
Regeneron Study Site
São Paulo
05403-010
Brazil
Regeneron Study Site 1
Las Condes
Santiago de Chile
7591047
Chile
Regeneron Study Site 2
Las Condes
Santiago de Chile
7591047
Chile
Regeneron Study Site
Vitacura
Santiago de Chile
7650568
Chile
Regeneron Study Site
Santiago
7500691
Chile
Regeneron Study Site
Guadalajara
Jalisco
44340
Mexico
Regeneron Study Site
Monterrey
Nuevo León
64718
Mexico
Regeneron Study Site
Culiacán
Sinaloa
80020
Mexico
Regeneron Study Site
Culiacán
80230
Mexico
Regeneron Study Site 1
Mérida
97000
Mexico
Regeneron Study Site 2
Mérida
97000
Mexico
Regeneron Study Site
Monterrey
64060
Mexico
Regeneron Study Site
Veracruz
91700
Mexico
Regeneron Study Site
Zapopan
45170
Mexico
Regeneron Study Site
Chisinau
MD-2025
Moldova
Regeneron Study Site
Bucharest
021105
Romania
Derived
Hooper AT, Somersan-Karakaya S, McCarthy SE, Mylonakis E, Ali S, Mei J, Bhore R, Mahmood A, Geba GP, Dakin P, Weinreich DM, Yancopoulos GD, Herman GA, Hamilton JD; COVID-19 Phase 2/3 Hospitalized Trial Team. Casirivimab and Imdevimab Treatment Reduces Viral Load and Improves Clinical Outcomes in Seropositive Hospitalized COVID-19 Patients with Nonneutralizing or Borderline Neutralizing Antibodies. mBio. 2022 Dec 20;13(6):e0169922. doi: 10.1128/mbio.01699-22. Epub 2022 Oct 18.
Somersan-Karakaya S, Mylonakis E, Menon VP, Wells JC, Ali S, Sivapalasingam S, Sun Y, Bhore R, Mei J, Miller J, Cupelli L, Forleo-Neto E, Hooper AT, Hamilton JD, Pan C, Pham V, Zhao Y, Hosain R, Mahmood A, Davis JD, Turner KC, Kim Y, Cook A, Kowal B, Soo Y, DiCioccio AT, Geba GP, Stahl N, Lipsich L, Braunstein N, Herman GA, Yancopoulos GD, Weinreich DM; COVID-19 Phase 2/3 Hospitalized Trial Team. Casirivimab and Imdevimab for the Treatment of Hospitalized Patients With COVID-19. J Infect Dis. 2022 Dec 28;227(1):23-34. doi: 10.1093/infdis/jiac320.
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 milligrams (mg) intravenously on Day 1 in Phase 1 (Cohort 1).
FG002
Phase 1: Cohort 1 (R10933+R10987 8000 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 1 (Cohort 1).
FG003
Phase 2: Cohort 1 (Placebo)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 1)
FG004
Phase 2: Cohort 1 (R10933+R10987 2400 mg
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 milligrams (mg) intravenously on Day 1 in Phase 2 (Cohort 1)
FG005
Phase 2: Cohort 1 (R10933+R10987 8000 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1)
FG006
Phase 3: Cohort 1 (Placebo)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1)
FG007
Phase 3: Cohort 1 (R10933+R10987 2400 mg)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 milligrams (mg) intravenously on Day 1 in Phase 3 (Cohort 1)
FG008
Phase 3: Cohort 1 (R10933+R10987 8000 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 3 (Cohort 1)
FG009
Phase 2: Cohort 1A (Placebo)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 1A).
FG010
Phase 2: Cohort 1A (R10933+R10987 2400 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1A).
FG011
Phase 2: Cohort 1A (R10933+R10987 8000 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1A).
FG012
Phase 2: Cohort 2 (Placebo)
Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 2).
FG013
Phase 2: Cohort 2 (R10933+R10987 2400 mg IV)
Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 2).
FG014
Phase 2: Cohort 2 (R10933+R10987 8000 mg IV)
Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 2).
FG015
Phase 2: Cohort 3 (Placebo)
Participants on mechanical ventilation received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 3).
FG016
Phase 2: Cohort 3 (R10933+R10987 2400 mg IV)
Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).
FG017
Phase 2: Cohort 3 (R10933+R10987 8000 mg IV)
Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).
FG00021 subjects
FG00119 subjects
FG00220 subjects
FG003208 subjects
FG004211 subjects
FG005210 subjects
FG006251 subjects
FG007252 subjects
FG008252 subjects
FG009201 subjects
FG010205 subjects
FG011203 subjects
FG01252 subjects
FG01358 subjects
FG01454 subjects
FG01512 subjects
FG01612 subjects
FG01711 subjects
Treated
FG00018 subjects
FG00118 subjects
FG00220 subjects
FG003204 subjects
FG004206 subjects
FG005205 subjects
FG006247 subjects
FG007246 subjects
FG008246 subjects
FG009198 subjects
FG010202 subjects
FG011197 subjects
FG01251 subjects
FG01356 subjects
FG01454 subjects
FG01512 subjects
FG01612 subjects
FG01711 subjects
COMPLETED
FG00013 subjects
FG00112 subjects
FG00216 subjects
FG003146 subjects
FG004153 subjects
FG005148 subjects
FG006186 subjects
FG007195 subjects
FG008189 subjects
FG009157 subjects
FG010165 subjects
FG011166 subjects
FG01233 subjects
FG01328 subjects
FG01431 subjects
FG0155 subjects
FG0164 subjects
FG0177 subjects
NOT COMPLETED
FG0008 subjects
FG0017 subjects
FG0024 subjects
FG00362 subjects
FG00458 subjects
FG00562 subjects
FG00665 subjects
FG00757 subjects
FG00863 subjects
FG00944 subjects
FG01040 subjects
FG01137 subjects
FG01219 subjects
FG01330 subjects
FG01423 subjects
FG0157 subjects
FG0168 subjects
FG0174 subjects
Type
Comment
Reasons
Death
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG00327 subjects
FG00425 subjects
FG00521 subjects
FG00642 subjects
FG00723 subjects
FG00837 subjects
FG00914 subjects
FG0108 subjects
FG0117 subjects
FG01213 subjects
FG01325 subjects
FG01419 subjects
FG0157 subjects
FG0168 subjects
FG0174 subjects
Lost to Follow-up
FG0002 subjects
FG0014 subjects
FG0021 subjects
FG00319 subjects
FG004
Participant Decision
FG0001 subjects
FG0012 subjects
FG0022 subjects
FG00312 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Sponsor Request
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Randomized but Never Treated
FG0003 subjects
FG0011 subjects
FG0020 subjects
FG0034 subjects
FG004
The full analysis set (FAS) included all randomized participants who received at least one dose (full or partial) of the study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase 1: Cohort 1 (Placebo)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 1 (Cohort 1)
BG001
Phase 1: Cohort 1 (R10933+R10987 2400 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 1 (Cohort 1)
BG002
Phase 1: Cohort 1 (R10933+R10987 8000 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 1 (Cohort 1)
BG003
Phase 2: Cohort 1 (Placebo)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 1)
BG004
Phase 2: Cohort 1 (R10933+R10987 2400 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1)
BG005
Phase 2: Cohort 1 (R10933+R10987 8000 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1)
BG006
Phase 3: Cohort 1 (Placebo)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1).
BG007
Phase 3: Cohort 1 (R10933+R10987 2400 mg IV)
Phase 1: Cohort 1 (R10933+R10987 2400 mg IV)Edit Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1.
BG008
Phase 3: Cohort 1 (R10933+R10987 8000 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 3 (Cohort 1)
BG009
Phase 2: Cohort 1A (Placebo)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 1A).
BG010
Phase 2: Cohort 1A (R10933+R10987 2400 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1A).
BG011
Phase 2: Cohort 1A (R10933+R10987 8000 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1A).
BG012
Phase 2: Cohort 2 (Placebo)
Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 2).
BG013
Phase 2: Cohort 2 (R10933+R10987 2400 mg IV)
Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 2).
BG014
Phase 2: Cohort 2 (R10933+R10987 8000 mg IV)
Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 2).
BG015
Phase 2: Cohort 3 (Placebo)
Participants on mechanical ventilation received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 3).
BG016
Phase 2: Cohort 3 (R10933+R10987 2400 mg IV)
Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).
BG017
Phase 2: Cohort 3 (R10933+R10987 8000 mg IV)
Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).
BG018
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00018
BG00118
BG00220
BG003204
BG004206
BG005205
BG006247
BG007246
BG008246
BG009198
BG010202
BG011197
BG01251
BG01356
BG01454
BG01512
BG01612
BG01711
BG0182203
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Age: 18- <40 years
Title
Measurements
BG0001
BG0011
BG0022
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0008
BG0018
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00012
BG0017
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Based on Seronegative mFAS
Time-weighted average daily change from Day 1 to Day 7 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.
The seronegative modified full analysis set (mFAS) was defined as all participants in mFAS with documented seronegative status at the baseline. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Least Squares Mean
Standard Error
log10 copies/milliliter (mL)
Day 1 to Day 7
ID
Title
Description
OG000
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).
OG001
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG002
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG003
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Units
Counts
Participants
OG000131
OG001150
OG002160
OG003
Title
Denominators
Categories
Title
Measurements
OG000-1.03± 0.10
OG001-1.28± 0.09
OG002-1.34± 0.09
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.0663
P-value for change from baseline on log scale for each treatment group was based on the Analysis of covariance (ANCOVA) model with treatment group.
Least Square (LS) Mean Difference
-0.25
2-Sided
95
-0.51
0.02
Superiority
OG000
OG002
ANCOVA
Primary
Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on High Viral Load mFAS
Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on high viral load mFAS were reported.
The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (>) 10^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 6 to Day 29
ID
Title
Description
OG000
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).
OG001
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Primary
Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Seronegative mFAS
Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on seronegative mFAS were reported.
The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 6 to Day 29
ID
Title
Description
OG000
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).
OG001
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Primary
Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Overall mFAS
Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on overall FAS were reported.
The mFAS included all FAS participants with a positive SARS-CoV-2 RT-qPCR conducted in the central laboratory in NP swab samples at randomization. Analysis based on treatment allocated (as randomized). "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 6 to Day 29
ID
Title
Description
OG000
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).
OG001
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Primary
Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on High Viral Load mFAS
Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on high viral load mFAS were reported.
The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load > 10^6 copies per mL. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 1 to Day 29
ID
Title
Description
OG000
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).
OG001
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Primary
Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Seronegative mFAS
Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on seronegative mFAS were reported.
The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 1 to Day 29
ID
Title
Description
OG000
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).
OG001
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Primary
Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Overall mFAS
Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on overall mFAS were reported.
The mFAS included all FAS participants with a positive SARS-CoV-2 RT-qPCR conducted in the central laboratory in NP swab samples at randomization. Analysis based on treatment allocated (as randomized). "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 1 to Day 29
ID
Title
Description
OG000
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).
OG001
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Primary
Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Treatment-Emergent Serious Adverse Events
Treatment-emergent adverse events are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the observation period.
The mFAS included all FAS participants with a positive SARS-CoV-2 RT-qPCR conducted in the central laboratory in NP swab samples at randomization. Analysis based on treatment allocated (as randomized). "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.
Posted
Count of Participants
Participants
Up to Day 169
ID
Title
Description
OG000
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1
OG001
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (2400 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1
Primary
Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade >=2 Infusion Related Reactions up to Day 4
Infusion-related reactions are defined as any relevant adverse event that occurs during the infusion or up to day 4. The severity of adverse events (including test findings classified as adverse events) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).
The mFAS included all FAS participants with a positive SARS-CoV-2 RT-qPCR conducted in the central laboratory in NP swab samples at randomization. Analysis based on treatment allocated (as randomized). "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.
Posted
Count of Participants
Participants
Up to Day 4
ID
Title
Description
OG000
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1
OG001
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (2400 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1
Primary
Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade >=2 Hypersensitivity Reactions Up to Day 29
Hypersensitivity reactions are defined as any relevant adverse event that occurs during the infusion or up to study day 29. The severity of adverse events (including test findings classified as adverse events) were graded according to NCI-CTCAE.
The mFAS included all FAS participants with a positive SARS-CoV-2 RT-qPCR conducted in the central laboratory in NP swab samples at randomization. Analysis based on treatment allocated (as randomized). "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.
Posted
Count of Participants
Participants
Up to Day 29
ID
Title
Description
OG000
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1
OG001
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (2400 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1
Primary
Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on Seronegative mFAS
Cumulative incidence percentage was estimated using Kaplan-Meier method.
Seronegative modified full analysis set (mFAS) was defined as all participants in mFAS with documented seronegative status at the baseline. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 1 [Cohort 1] and Phase 2 [Cohort 1].
Posted
Number
80% Confidence Interval
Cumulative Incidence Percentage
Up to Day 29
ID
Title
Description
OG000
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1
OG001
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (2400 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1
OG002
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV)
Primary
Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on High Viral Load mFAS
Cumulative incidence percentage was estimated using Kaplan-Meier method.
High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (>) 10^6 copies per milliliter (mL). As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 1 [Cohort 1] and Phase 2 [Cohort 1].
Posted
Number
80% Confidence Interval
Cumulative Incidence Percentage
Up to Day 29
ID
Title
Description
OG000
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1
OG001
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (2400 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1
OG002
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV)
Secondary
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS
Percentage of participants who went on mechanical ventilation by Day 29 based on High Viral Load mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.
The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load > 10^6 copies per mL. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Percentage of Participants
by Day 29
ID
Title
Description
OG000
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).
OG001
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Secondary
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS
Percentage of participants who went on mechanical ventilation at Day 29 based on Seronegative mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.
The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Percentage of Participants
by Day 29
ID
Title
Description
OG000
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).
OG001
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Secondary
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on High Viral Load mFAS
Percentage of participants who died from Day 6 through Day 29 based on high viral load mFAS were reported.
The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load > 10^6 copies per mL. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 6 to Day 29
ID
Title
Description
OG000
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).
OG001
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Secondary
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS
Percentage of participants who died from Day 6 through Day 29 Based on seronegative mFAS in pooled analysis phase 3 (cohort 1) and phase 2 (cohort 1A) were reported.
The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 6 to Day 29
ID
Title
Description
OG000
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).
OG001
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Secondary
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on High Viral Load mFAS
Percentage of participants who died from Day 1 through Day 29 based on High Viral Load mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.
The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load > 10^6 copies per mL. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 29
ID
Title
Description
OG000
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).
OG001
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Secondary
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS
Percentage of participants who died from Day 1 through Day 29 based on seronegative mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.
The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 1 to Day 29
ID
Title
Description
OG000
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).
OG001
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Secondary
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS
Percentage of participants who were discharged by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported.
The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load > 10^6 copies per mL. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Percentage of Participants
by Day 29
ID
Title
Description
OG000
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).
OG001
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Secondary
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS
Percentage of participants who were discharged by Day 29 based on seronegative mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported.
The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Percentage of Participants
by Day 29
ID
Title
Description
OG000
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).
OG001
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Secondary
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS
Percentage of participants who died or were readmitted to hospital over time based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A)were reported. Readmission to hospital was based on investigator report.
The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load > 10^6 copies per mL. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to Day 29
ID
Title
Description
OG000
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).
OG001
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)
Secondary
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS
Percentage of participants who died or were readmitted to hospital at Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Readmission to hospital was based on investigator report.
The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Percentage of Participants
by Day 29
ID
Title
Description
OG000
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).
OG001
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)
Secondary
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on High Viral Load mFAS
Overall Survival was defined as time interval from randomization to death. Percentage of participants with cumulative incidence of death (ie, overall survival) at Day 29 from randomization based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load > 10^6 copies per mL. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Cumulative Incidence Percentage
by Day 29
ID
Title
Description
OG000
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).
OG001
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)
Secondary
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on Seronegative mFAS
Overall Survival was defined as time interval from randomization to death. Percentage of participants with cumulative incidence of death (ie, overall survival) at Day 29 from randomization based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A)were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Cumulative Incidence Percentage
by Day 29
ID
Title
Description
OG000
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).
OG001
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)
Secondary
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on High Viral Load mFAS
Number of participants with cumulative incidence of mechanical ventilation by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load > 10^6 copies per mL. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Cumulative Incidence Percentage
by Day 29
ID
Title
Description
OG000
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).
OG001
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)
Secondary
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS
Percentage of participants with cumulative incidence of mechanical ventilation by Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Cumulative Incidence Percentage
by Day 29
ID
Title
Description
OG000
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).
OG001
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)
Secondary
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on High Viral Load mFAS
Percentage of participants with cumulative incidence of death or mechanical ventilation by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load > 10^6 copies per mL. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Cumulative Incidence Percentage
by Day 29
ID
Title
Description
OG000
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).
OG001
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)
Secondary
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS
Percentage of participants with cumulative incidence of death or mechanical ventilation by Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Cumulative Incidence Percentage
by Day 29
ID
Title
Description
OG000
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).
OG001
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)
Secondary
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on High Viral Load mFAS
Time to discharge from hospital based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) was reported.
The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load > 10^6 copies per mL. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Median
95% Confidence Interval
Days
Up to Day 56
ID
Title
Description
OG000
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).
OG001
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Secondary
Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS
Time to discharge from hospital based on Seronegative mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) was reported.
The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Median
95% Confidence Interval
Days
Up to Day 56
ID
Title
Description
OG000
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).
OG001
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Secondary
Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Treatment-Emergent Serious Adverse Events
all FAS participants. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.
Posted
Count of Participants
Participants
Up to Day 169
ID
Title
Description
OG000
Pooled Placebo
Participants received single dose of placebo matching to R10933+R10987 intravenously on Day 1
OG001
Pooled R10933+R10987 2400 mg IV
Participants received a single dose of R10933+R10987 2400 mg intravenously on Day 1
OG002
Pooled R10933+R10987 8000 mg IV
Participants received a single dose of R10933+R10987 8000 mg intravenously on Day 1.
OG003
Pooled Combined R10933+R10987 IV
Participants received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1
Secondary
Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade >=2 Infusion Related Reactions up to Day 4
all FAS participants. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.
Posted
Count of Participants
Participants
Up to Day 4
ID
Title
Description
OG000
Pooled Placebo
Participants received single dose of placebo matching to R10933+R10987 intravenously on Day 1
OG001
Pooled R10933+R10987 2400 mg IV
Participants received a single dose of R10933+R10987 2400 mg intravenously on Day 1
OG002
Pooled R10933+R10987 8000 mg IV
Participants received a single dose of R10933+R10987 8000 mg intravenously on Day 1
OG003
Pooled Combined R10933+R10987 IV
Participants received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1
Secondary
Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade >=2 Hypersensitivity Reactions Up to Day 29
all FAS participants. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.
Posted
Count of Participants
Participants
Up to Day 29
ID
Title
Description
OG000
Pooled Placebo
Participants received single dose of placebo matching to R10933+R10987 intravenously on Day 1
OG001
Pooled R10933+R10987 2400 mg IV
Participants received a single dose of R10933+R10987 2400 mg intravenously on Day 1
OG002
Pooled R10933+R10987 8000 mg IV
Participants received a single dose of R10933+R10987 8000 mg intravenously on Day 1
OG003
Pooled Combined R10933+R10987 IV
Participants received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1
Secondary
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS
Percentage of participants who went on mechanical ventilation in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.
The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Percentage of Participants
by Day 29
ID
Title
Description
OG000
Phase 3: Cohort 1 (Placebo)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1
OG001
Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.
OG002
Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)
Secondary
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS
Percentage of participants who died from Day 6 through Day 29 in phase 3 (cohort 1) and phase 2 (cohort 1A) were reported.
The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 6 to Day 29
ID
Title
Description
OG000
Phase 3: Cohort 1 (Placebo)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1
OG001
Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.
OG002
Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)
Secondary
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS
Percentage of participants who died from Day 1 through Day 29 in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.
The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 1 to Day 29
ID
Title
Description
OG000
Phase 3: Cohort 1 (Placebo)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1
OG001
Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1
OG002
Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)
Secondary
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS
Percentage of participants who were discharged in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported.
The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Percentage of Participants
by Day 29
ID
Title
Description
OG000
Phase 3: Cohort 1 (Placebo)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1
OG001
Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.
OG002
Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)
Secondary
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS
Percentage of participants who died or were readmitted to hospital in phase 3 (Cohort 1) and phase 2 (Cohort 1A) by Day 29 were reported. Readmission to hospital was based on investigator report.
The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to Day 29
ID
Title
Description
OG000
Phase 3: Cohort 1 (Placebo)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1
OG001
Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.
Secondary
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death up to Day 29 Based on Seronegative mFAS
Percentage of participants with cumulative incidence of death in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) up to Day 29 from randomization were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Cumulative Incidence Percentage
Up to Day 29
ID
Title
Description
OG000
Phase 3: Cohort 1 (Placebo)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1
OG001
Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.
Secondary
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS
Percentage of participants with cumulative incidence of mechanical ventilation in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Cumulative Incidence Percentage
by Day 29
ID
Title
Description
OG000
Phase 3: Cohort 1 (Placebo)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1
OG001
Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.
Secondary
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS
Percentage of participants with cumulative incidence of death or mechanical ventilation in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Cumulative Incidence Percentage
by Day 29
ID
Title
Description
OG000
Phase 3: Cohort 1 (Placebo)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1
OG001
Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.
Secondary
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS
Time to discharge from hospital up to Day 56 was reported.
The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Median
95% Confidence Interval
Days
Up to Day 56
ID
Title
Description
OG000
Phase 3: Cohort 1 (Placebo)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1
OG001
Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.
OG002
Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)
Secondary
Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 11 Based on Seronegative mFAS
TWA change from baseline in viral load up to Day 11 was calculated for each participant using the trapezoidal rule as the area under the curve for change from baseline at each time point divided by the time interval for the observation period. TWA change from baseline viral load in NP samples through Day 11, was measured by RT-qPCR in NP swab samples was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicate improvement in viral load.
The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Least Squares Mean
Standard Error
log10 copies/mL
Day 1 to Day 11
ID
Title
Description
OG000
Phase 3: Cohort 1 (Placebo)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1
OG001
Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)
Secondary
Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 29
TWA change from baseline in viral load up to Day 29 was calculated for each participant using the trapezoidal rule as the area under the curve for change from baseline at each time point divided by the time interval for the observation period. TWA change from baseline viral load in NP samples through Day 29, was measured by quantitative RT-qPCR in NP swab samples was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicate improvement in viral load.
The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Least Squares Mean
Standard Error
log10 copies/mL
Day 1 to Day 29
ID
Title
Description
OG000
Phase 3: Cohort 1 (Placebo)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1
OG001
Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)
Secondary
Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time
Change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.
The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. "Number of Participants Analyzed" = participants with measurements at baseline. "Number Analyzed" = participants with measurements for both baseline and the specific study day. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Least Squares Mean
Standard Error
log10 copies/mL
Days 3, 5, 7, 9, 11, 13, 15, 22 and 29
ID
Title
Description
OG000
Phase 3: Cohort 1 (Placebo)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1
OG001
Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.
Secondary
Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time
Percent change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.
The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Number of Participants Analyzed" = participants with measurements at baseline. "Number Analyzed" = participants with measurements for both baseline and the specific study day. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Least Squares Mean
95% Confidence Interval
Percent Change
Days 3, 5, 7, 9, 11, 13, 15, 22 and 29
ID
Title
Description
OG000
Phase 3: Cohort 1 (Placebo)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1
OG001
Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.
Secondary
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS
Percentage of participants who went on mechanical ventilation in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.
The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (>) 10^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Percentage of Participants
by Day 29
ID
Title
Description
OG000
Phase 3: Cohort 1 (Placebo)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1
OG001
Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.
OG002
Secondary
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 to Day 29 Based on High Viral Load mFAS
Percentage of participants who died in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.
The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (>) 10^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 6 to Day 29
ID
Title
Description
OG000
Phase 3: Cohort 1 (Placebo)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1
OG001
Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.
OG002
Secondary
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 to Day 29 Based on High Viral Load mFAS
Percentage of participants who died in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.
The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (>) 10^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 1 to Day 29
ID
Title
Description
OG000
Phase 3: Cohort 1 (Placebo)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1
OG001
Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.
OG002
Secondary
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS
Percentage of participants who were discharged in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.
The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (>) 10^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Percentage of Participants
by Day 29
ID
Title
Description
OG000
Phase 3: Cohort 1 (Placebo)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1
OG001
Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.
OG002
Secondary
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS
Percentage of participants who died or were readmitted to hospital in phase 3 (Cohort 1) and phase 2 (Cohort 1A) over time were reported. Readmission to hospital was based on investigator report.
The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (>) 10^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to Day 29
ID
Title
Description
OG000
Phase 3: Cohort 1 (Placebo)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1
OG001
Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1
Secondary
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death Over Time Based on High Viral Load mFAS
Cumulative Incidence of Death Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (>) 10^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Cumulative Incidence Percentage
Up to Day 29
ID
Title
Description
OG000
Phase 3: Cohort 1 (Placebo)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1
OG001
Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.
Secondary
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation Over Time Based on High Viral Load mFAS
Cumulative Incidence of Mechanical Ventilation Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (>) 10^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Cumulative Incidence Percentage
Up to Day 29
ID
Title
Description
OG000
Phase 3: Cohort 1 (Placebo)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1
OG001
Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.
Secondary
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation Over Time Based on High Viral Load mFAS
Cumulative Incidence of Death or Mechanical Ventilation Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (>) 10^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Number
95% Confidence Interval
Cumulative Incidence Percentage
Up to Day 29
ID
Title
Description
OG000
Phase 3: Cohort 1 (Placebo)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1
OG001
Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.
Secondary
Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge Based on High Viral Load mFAS
Time to Discharge in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.
The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (>) 10^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].
Posted
Median
95% Confidence Interval
days
Up to Day 56
ID
Title
Description
OG000
Phase 3: Cohort 1 (Placebo)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1
OG001
Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.
OG002
Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)
Secondary
Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS
Time-weighted average daily change over time up to Day 29 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.
Seronegative modified full analysis set (mFAS) = all participants in mFAS with documented seroneg status at baseline. "Number of Participants Analyzed" = participants with measurements at baseline. "Number Analyzed" = participants with measurements at both baseline and specific study day. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected/reported for Phase 1 [Cohort 1] and Phase 2 [Cohort 1].
Posted
Least Squares Mean
Standard Error
log10 copies/milliliter (mL)
Up to Day 29
ID
Title
Description
OG000
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1
OG001
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (2400 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1
Secondary
Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS
Change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.
Seronegative modified full analysis set (mFAS) = all participants in mFAS with documented seroneg status at baseline. "Number of Participants Analyzed" = participants with measurements at baseline. "Number Analyzed" = participants with measurements at both baseline and specific study day. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected/reported for Phase 1 [Cohort 1] and Phase 2 [Cohort 1].
Posted
Least Squares Mean
Standard Error
log10 copies/milliliter (mL)
Days 3, 5, 7, 9, 11, 13, 15, 22 and 29
ID
Title
Description
OG000
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1
OG001
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (2400 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1
Secondary
Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on Seronegative mFAS
Seronegative modified full analysis set (mFAS) was defined as all participants in mFAS with documented seronegative status at the baseline. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 1 [Cohort 1] and Phase 2 [Cohort 1].
Posted
Number
80% Confidence Interval
Percentage of Participants
Through Day 29
ID
Title
Description
OG000
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1
OG001
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (2400 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1
OG002
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1
Secondary
Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on High Viral Load mFAS
The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (>) 10^6 copies per milliliter (mL). Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 1 [Cohort 1] and Phase 2 [Cohort 1].
Posted
Number
80% Confidence Interval
Percentage of Participants
Through Day 29
ID
Title
Description
OG000
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Placebo
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1
OG001
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (2400 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1
OG002
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV)
Secondary
Phase 1 [Cohort 1]: Area Under the Concentration-Time Curve From Time 0 to 28 Days Post-dose (AUC0-28)
Participants in Phase 1 (Cohort 1) who received any study drug of casirivimab and imdevimab and who had at least 1 non-missing drug concentration measurement following the first dose of study drug
Posted
Mean
Standard Deviation
day*mg/L
Up to Day 28
ID
Title
Description
OG000
Phase 1 [Cohort 1]: R10983+10987 2400mg IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1
OG001
Phase 1 [Cohort 1]: R10983+10987 8000mg IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1
Units
Counts
Participants
OG000
Secondary
Concentration at the End of Infusion (Ceoi)
Participants who received any study drug of casirivimab and imdevimab
Posted
Mean
Standard Deviation
milligrams per liter (mg/L)
Day 1
ID
Title
Description
OG000
Phase 1 [Cohort 1]: R10983+10987 2400mg IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 1 (Cohort 1).
OG001
Phase 1 [Cohort 1]: R10983+10987 8000mg IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 1 (Cohort 1).
OG002
Phase 2 (Cohort 1A): R10933+R10987 2400mg IV
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1A).
OG003
Phase 2 (Cohort 1A): R10933+R10987 8000mg IV
Secondary
Concentration at Day 28 (C28)
Participants who received any study drug of casirivimab and imdevimab and who had at least 1 non-missing drug concentration measurement following the first dose of study drug
Posted
Mean
Standard Deviation
mg/L
Day 28
ID
Title
Description
OG000
Phase 1 [Cohort 1]: R10983+10987 2400mg IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 1 (Cohort 1).
OG001
Phase 1 [Cohort 1]: R10983+10987 8000mg IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 1 (Cohort 1)
OG002
Phase 2 (Cohort 1A): R10933+R10987 2400mg IV
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1A).
OG003
Phase 2 (Cohort 1A): R10933+R10987 8000mg IV
Secondary
Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933
ADA analysis set includes all treated participants from all phases/cohorts who received any amount of study drug and had at least one non-missing antibody variables result following the first dose of study drug or placebo.
Posted
Count of Participants
Participants
Through Day 169
ID
Title
Description
OG000
Pooled Placebo
Participants received single dose of placebo matching to R10933+R10987 intravenously on Day 1
OG001
Pooled R10933+R10987 2400mg IV
Participants received a single 2400mg intravenous dose of R10933+R10987
OG002
Pooled REGN10933+REGN10987 8000mg IV
Participants received a single 8000 mg intravenous dose of R10933+R10987
Units
Counts
Participants
Secondary
Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987
ADA analysis set includes all treated participants from all phases/cohorts who received any amount of study drug and had at least one non-missing antibody variables result following the first dose of study drug or placebo.
Posted
Count of Participants
Participants
Through Day 169
ID
Title
Description
OG000
Pooled Placebo
Participants received a single intravenous dose of placebo matching R10933+R10987
OG001
Pooled R10933+R10987 2400mg IV
Participants received a single 2400mg dose of R10933+R10987 intravenously on Day 1
OG002
Pooled REGN10933+REGN10987 8000mg IV
Participants received a single 8000 mg dose of R10933+R10987 intravenously on Day 1
Units
Counts
Participants
Secondary
Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10933
NAb analysis set includes all Phase 2/3 treated participants who received any study drug, had at least one non-missing antibody result following the first dose of study drug, and either tested negative at all ADA sampling times or tested positive for ADA with at least one non-missing NAb result after first dose of the study drug.
Posted
Count of Participants
Participants
Through Day 57
ID
Title
Description
OG000
Pooled (Phase 2/3) Placebo
Participants received single dose of placebo matching to R10933+R10987 intravenously on Day 1
OG001
Pooled (Phase 2/3) R10933+R10987 2400mg IV
Participants received a single 2400mg intravenous dose of R10933+R10987
OG002
Pooled (Phase 2/3) REGN10933+REGN10987 8000mg IV
Participants received a single 8000 mg intravenous dose of R10933+R10987
Units
Counts
Participants
Secondary
Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10987
NAb analysis set includes all Phase 2/3 treated participants who received any study drug, had at least one non-missing antibody result following the first dose of study drug, and either tested negative at all ADA sampling times or tested positive for ADA with at least one non-missing NAb result after first dose of the study drug.
Posted
Count of Participants
Participants
Through Day 57
ID
Title
Description
OG000
Pooled (Phase 2/3) Placebo
Participants received single dose of placebo matching to R10933+R10987 intravenously on Day 1
OG001
Pooled (Phase 2/3) R10933+R10987 2400mg IV
Participants received a single 2400mg intravenous dose of R10933+R10987
OG002
Pooled (Phase 2/3) REGN10933+REGN10987 8000mg IV
Participants received a single 8000 mg intravenous dose of R10933+R10987
Units
Counts
Participants
Time Frame
From first dose of study drug to Day 169
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Phase 1 Cohort 1: Placebo IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 1 (Cohort 1).
2
18
3
18
0
18
EG001
Phase 1 Cohort 1: R10933+R10987 2400mg IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 milligrams (mg) intravenously on Day 1 in Phase 1 (Cohort 1).
0
18
3
18
0
18
EG002
Phase 1 Cohort 1: R10933+R10987 8000mg IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 1 (Cohort 1).
1
20
2
20
1
20
EG003
Phase 2 Cohort 1A: Placebo IV
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 1A).
15
198
43
198
0
198
EG004
Phase 2 Cohort 1A: R10933+R10987 2400mg IV
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1A).
8
202
29
202
0
202
EG005
Phase 2 Cohort 1A: R10933+R10987 8000mg IV
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1A).
7
197
32
197
0
197
EG006
Phase 2 Cohort 1: Placebo IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 1).
28
204
63
204
0
204
EG007
Phase 2 Cohort 1: R10933+R10987 2400mg IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1).
25
206
47
206
0
206
EG008
Phase 2 Cohort 1: R10933+R10987 8000mg IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1).
21
205
47
205
0
205
EG009
Phase 2 Cohort 2: Placebo IV
Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 2).
13
51
20
51
0
51
EG010
Phase 2 Cohort 2: R10933+R10987 2400mg IV
Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 2).
25
56
31
56
0
56
EG011
Phase 2 Cohort 2: R10933+R10987 8000mg IV
Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 2).
19
54
26
54
0
54
EG012
Phase 2 Cohort 3: Placebo IV
Participants on mechanical ventilation received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 3).
7
12
9
12
0
12
EG013
Phase 2 Cohort 3: R10933+R10987 2400mg IV
Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).
8
12
11
12
1
12
EG014
Phase 2 Cohort 3: R10933+R10987 8000mg IV
Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).
4
11
5
11
1
11
EG015
Phase 3 Cohort 1: Placebo IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1).
42
247
65
247
0
247
EG016
Phase 3 Cohort 1: R10933+R10987 2400mg IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 3 (Cohort 1).
24
246
56
246
1
246
EG017
Phase 3 Cohort 1: R10933+R10987 8000mg IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 3 (Cohort 1).
37
246
69
246
2
246
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG0032 events2 affected198 at risk
EG004
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Alveolar lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Idiopathic pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Laryngeal stenosis
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Organising pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Pneumomediastinum
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Pneumothorax spontaneous
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Pulmonary artery thrombosis
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Respiratory arrest
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
COVID-19
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0001 events1 affected18 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Appendicitis perforated
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Arthritis bacterial
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Aspergillus infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Burkholderia cepacia complex infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Candida infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Candida sepsis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Cytomegalovirus infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Device related bacteraemia
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Emphysematous cholecystitis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Encephalitis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Enterococcal infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Fungaemia
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Ophthalmic herpes zoster
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Osteomyelitis fungal
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Perirectal abscess
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Pneumococcal infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Pneumonia klebsiella
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Pneumonia serratia
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Pneumonia staphylococcal
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Post procedural infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Pseudomonal sepsis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Pulmonary sepsis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Scrotal abscess
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Sepsis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Septic shock
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Serratia infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Superinfection bacterial
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Urinary tract candidiasis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Urinary tract infection enterococcal
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Urosepsis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Viral cardiomyopathy
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Viral myocarditis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (24.0)
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected18 at risk
EG0022 events1 affected20 at risk
EG003
End stage renal disease
Renal and urinary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Renal tubular injury
Renal and urinary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Hypercoagulation
Blood and lymphatic system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Sickle cell anaemia with crisis
Blood and lymphatic system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Acute left ventricular failure
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Atrial tachycardia
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Cardiac failure acute
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Cardiac failure chronic
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Cardiogenic shock
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Chronic left ventricular failure
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Pulseless electrical activity
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Blindness unilateral
Eye disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Intestinal ischaemia
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Mallory-Weiss syndrome
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Retroperitoneal haematoma
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Retroperitoneal haemorrhage
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Asthenia
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Chest pain
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Chills
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Death
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Fatigue
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Generalised oedema
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Pain
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Sudden cardiac death
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Systemic inflammatory response syndrome
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Acute hepatic failure
Hepatobiliary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Hepatic cirrhosis
Hepatobiliary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Ischaemic hepatitis
Hepatobiliary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Lung transplant rejection
Immune system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Acetabulum fracture
Injury, poisoning and procedural complications
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Brain herniation
Injury, poisoning and procedural complications
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Endotracheal intubation complication
Injury, poisoning and procedural complications
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Gastrointestinal stoma complication
Injury, poisoning and procedural complications
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Pancreatic leak
Injury, poisoning and procedural complications
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Stomal hernia
Injury, poisoning and procedural complications
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Blood glucose increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
ECG signs of myocardial ischaemia
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Fibrin D dimer increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Inflammatory marker increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
International normalised ratio increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Klebsiella test positive
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Mean arterial pressure increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Oxygen saturation decreased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Acidosis
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Calciphylaxis
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Compartment syndrome
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Appendix cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Chronic myelomonocytic leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Dementia Alzheimer's type
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Depressed level of consciousness
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Hydrocephalus
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Metabolic encephalopathy
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Multiple sclerosis relapse
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Seizure
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Syncope
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Toxic encephalopathy
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Transverse sinus thrombosis
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Unresponsive to stimuli
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Device occlusion
Product Issues
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Delirium
Psychiatric disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Subcutaneous emphysema
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Ileostomy closure
Surgical and medical procedures
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Arteriosclerosis
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Distributive shock
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Embolism venous
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Haematoma
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Hypertensive urgency
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Hypotension
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0022 events1 affected20 at risk
EG003
Hypovolaemic shock
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Peripheral artery occlusion
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Shock
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Shock haemorrhagic
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Venous thrombosis
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Venous thrombosis limb
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
COVID-19
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected20 at risk
EG0030 events0 affected198 at risk
EG0040 events0 affected202 at risk
EG0050 events0 affected197 at risk
EG0060 events0 affected204 at risk
EG0070 events0 affected206 at risk
EG0080 events0 affected205 at risk
EG0090 events0 affected51 at risk
EG0100 events0 affected56 at risk
EG0110 events0 affected54 at risk
EG0120 events0 affected12 at risk
EG0130 events0 affected12 at risk
EG0140 events0 affected11 at risk
EG0150 events0 affected247 at risk
EG0160 events0 affected246 at risk
EG0170 events0 affected246 at risk
Enterocolitis infectious
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Peroneal nerve palsy
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Delirium
Psychiatric disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Haematoma
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
P-value for change from baseline on log scale for each treatment group was based on the Analysis of covariance (ANCOVA) model with treatment group.
Least Square (LS) Mean Difference
-0.31
95
-0.57
0.05
Superiority
OG000
OG003
To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.
ANCOVA
0.0172
P-value for change from baseline on log scale for each treatment group was based on the Analysis of covariance (ANCOVA) model with treatment group.
Least Square (LS) Mean Difference
-0.28
2-Sided
95
-0.51
-0.05
Superiority
OG002
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG003
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Units
Counts
Participants
OG000211
OG001220
OG002225
OG003445
Title
Denominators
Categories
Title
Measurements
OG00013.3(9.0 to 18.6)
OG0017.3(4.2 to 11.5)
OG00212.4(8.4 to 17.5)
OG0039.9(7.3 to 13.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.0431
P-value was derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value was based on Fisher Exact Test.
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.7975
P-value was derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value was based on Fisher Exact Test.
Superiority
OG000
OG003
To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.
Cochran-Mantel-Haenszel
0.2048
P-value was derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value was based on Fisher Exact Test.
Superiority
OG002
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG003
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Units
Counts
Participants
OG000147
OG001162
OG002179
OG003341
Title
Denominators
Categories
Title
Measurements
OG00015.0(9.6 to 21.8)
OG0014.9(2.2 to 9.5)
OG00210.6(6.5 to 16.1)
OG0037.9(5.3 to 11.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.0039
P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value was based on Fisher Exact Test.
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.2415
P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value was based on Fisher Exact Test.
Superiority
OG000
OG003
To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.
Cochran-Mantel-Haenszel
0.0195
P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value was based on Fisher Exact Test.
Superiority
OG002
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG003
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Units
Counts
Participants
OG000367
OG001387
OG002383
OG003770
Title
Denominators
Categories
Title
Measurements
OG00010.6(7.7 to 14.2)
OG0015.4(3.4 to 8.2)
OG00210.7(7.8 to 14.2)
OG0038.1(6.2 to 10.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.0085
P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < = 5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.9902
P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < = 5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG003
To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.
Cochran-Mantel-Haenszel
0.1486
P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < = 5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG002
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG003
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Units
Counts
Participants
OG000229
OG001231
OG002236
OG003467
Title
Denominators
Categories
Title
Measurements
OG00018.8(13.9 to 24.4)
OG00110.0(6.4 to 14.6)
OG00214.4(10.2 to 19.5)
OG00312.2(9.4 to 15.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.0092
P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < = 5 or n(1-p) <= 5 in any treatment group, p-value was based on Fisher Exact Test.
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.2210
P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < = 5 or n(1-p) <= 5 in any treatment group, p-value was based on Fisher Exact Test.
Superiority
OG000
OG003
To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.
Cochran-Mantel-Haenszel
0.0249
P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < = 5 or n(1-p) <= 5 in any treatment group, p-value was based on Fisher Exact Test.
Superiority
OG002
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG003
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Units
Counts
Participants
OG000160
OG001172
OG002188
OG003360
Title
Denominators
Categories
Title
Measurements
OG00019.4(13.6 to 26.4)
OG0018.1(4.5 to 13.3)
OG00212.2(7.9 to 17.8)
OG00310.3(7.3 to 13.9)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.0045
P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < = 5 or n(1-p) <= 5 in any treatment group, p-value was based on Fisher Exact Test.
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.0714
P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < = 5 or n(1-p) <= 5 in any treatment group, p-value was based on Fisher Exact Test.
Superiority
OG000
OG003
To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.
Cochran-Mantel-Haenszel
0.0061
P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < = 5 or n(1-p) <= 5 in any treatment group, p-value was based on Fisher Exact Test.
Superiority
OG002
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG003
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Units
Counts
Participants
OG000393
OG001406
OG002398
OG003804
Title
Denominators
Categories
Title
Measurements
OG00014.8(11.4 to 18.7)
OG0017.9(5.5 to 10.9)
OG00212.6(9.5 to 16.2)
OG00310.2(8.2 to 12.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.0023
P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < = 5 or n(1-p) <= 5 in any treatment group, p-value was based on Fisher Exact Test.
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.3544
P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < = 5 or n(1-p) <= 5 in any treatment group, p-value was based on Fisher Exact Test.
Superiority
OG000
OG003
To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.
Cochran-Mantel-Haenszel
0.0212
P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < = 5 or n(1-p) <= 5 in any treatment group, p-value was based on Fisher Exact Test.
Superiority
OG002
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1
OG003
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1
Units
Counts
Participants
OG000222
OG001224
OG002225
OG003449
Title
Denominators
Categories
Title
Measurements
OG00054
OG00145
OG00247
OG00392
OG002
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1
OG003
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1
Units
Counts
Participants
OG000222
OG001224
OG002225
OG003449
Title
Denominators
Categories
Title
Measurements
OG0003
OG0012
OG0026
OG0038
OG002
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1
OG003
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1
Units
Counts
Participants
OG000222
OG001224
OG002225
OG003449
Title
Denominators
Categories
Title
Measurements
OG0001
OG0012
OG0022
OG0034
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1
OG003
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1
Units
Counts
Participants
OG00032
OG00146
OG00241
OG00387
Title
Denominators
Categories
Title
Measurements
OG00023.0(16.9 to 30.9)
OG00115.1(10.5 to 21.4)
OG00220.3(14.7 to 27.8)
OG00317.6(13.8 to 22.3)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1
OG003
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1
Units
Counts
Participants
OG00050
OG00153
OG00258
OG003111
Title
Denominators
Categories
Title
Measurements
OG00020.7(15.7 to 26.9)
OG00118.9(14.3 to 24.8)
OG00211.6(8.0 to 16.8)
OG00315.3(12.2 to 19.0)
OG002
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG003
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Units
Counts
Participants
OG000229
OG001231
OG002236
OG003467
Title
Denominators
Categories
Title
Measurements
OG00011.4(7.6 to 16.2)
OG0016.1(3.4 to 10.0)
OG0028.5(5.3 to 12.8)
OG0037.3(5.1 to 10.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.0575
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.3133
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG003
Cochran-Mantel-Haenszel
0.0849
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG002
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG003
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Units
Counts
Participants
OG000160
OG001172
OG002188
OG003360
Title
Denominators
Categories
Title
Measurements
OG00010.0(5.8 to 15.7)
OG0015.8(2.8 to 10.4)
OG0027.4(4.1 to 12.2)
OG0036.7(4.3 to 9.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.2167
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.4123
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG003
Cochran-Mantel-Haenszel
0.2206
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG002
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG003
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Units
Counts
Participants
OG000222
OG001226
OG002228
OG003454
Title
Denominators
Categories
Title
Measurements
OG00013.1(8.9 to 18.2)
OG0017.1(4.1 to 11.2)
OG00210.1(6.5 to 14.8)
OG0038.6(6.2 to 11.6)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.0383
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.3296
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG003
Cochran-Mantel-Haenszel
0.0766
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG002
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG003
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Units
Counts
Participants
OG000153
OG001167
OG002181
OG003348
Title
Denominators
Categories
Title
Measurements
OG00013.7(8.7 to 20.2)
OG0014.8(2.1 to 9.2)
OG0027.2(3.9 to 12.0)
OG0036.0(3.8 to 9.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.0070
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.0507
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG003
Cochran-Mantel-Haenszel
0.0051
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG002
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG003
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Units
Counts
Participants
OG000229
OG001231
OG002236
OG003467
Title
Denominators
Categories
Title
Measurements
OG00014.4(10.1 to 19.6)
OG0017.4(4.3 to 11.5)
OG00211.0(7.3 to 15.7)
OG0039.2(6.7 to 12.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.0174
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.2900
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG003
Cochran-Mantel-Haenszel
0.0454
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG002
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG003
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Units
Counts
Participants
OG000160
OG001172
OG002188
OG003360
Title
Denominators
Categories
Title
Measurements
OG00015.0(9.9 to 21.5)
OG0015.2(2.4 to 9.7)
OG0028.0(4.5 to 12.8)
OG0036.7(4.3 to 9.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.0040
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.0413
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG003
Cochran-Mantel-Haenszel
0.0032
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG002
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG003
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Units
Counts
Participants
OG000229
OG001231
OG002236
OG003467
Title
Denominators
Categories
Title
Measurements
OG00080.3(74.6 to 85.3)
OG00189.2(84.4 to 92.9)
OG00286.9(81.9 to 90.9)
OG00388.0(84.7 to 90.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.0105
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.0622
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG003
Cochran-Mantel-Haenszel
0.0088
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG002
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG003
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Units
Counts
Participants
OG000160
OG001172
OG002188
OG003360
Title
Denominators
Categories
Title
Measurements
OG00081.3(74.3 to 87.0)
OG00190.1(84.6 to 94.1)
OG00289.9(84.7 to 93.8)
OG00390.0(86.4 to 92.9)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.0275
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.0223
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG003
Cochran-Mantel-Haenszel
0.0072
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG002
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG003
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Units
Counts
Participants
OG000229
OG001231
OG002236
OG003467
Title
Denominators
Categories
Title
Measurements
OG00021.0(15.9 to 26.8)
OG00115.2(10.8 to 20.4)
OG00217.4(12.8 to 22.8)
OG00316.3(13.0 to 19.9)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.1032
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.3350
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG003
Cochran-Mantel-Haenszel
0.1314
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG002
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG003
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Units
Counts
Participants
OG000160
OG001172
OG002188
OG003360
Title
Denominators
Categories
Title
Measurements
OG00024.4(17.9 to 31.8)
OG00111.6(7.2 to 17.4)
OG00212.8(8.4 to 18.4)
OG00312.2(9.0 to 16.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.00024
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.0054
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG003
Cochran-Mantel-Haenszel
0.0005
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG002
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG003
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Units
Counts
Participants
OG000181
OG001201
OG002190
OG003391
Title
Denominators
Categories
Title
Measurements
OG00014.9(10.8 to 20.3)
OG0017.7(4.8 to 12.1)
OG00211.7(8.1 to 16.7)
OG0039.7(7.3 to 12.9)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG002
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG003
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Units
Counts
Participants
OG000121
OG001148
OG002160
OG003308
Title
Denominators
Categories
Title
Measurements
OG00015.8(10.9 to 22.7)
OG0015.6(3.0 to 10.5)
OG0028.4(5.1 to 13.5)
OG0037.0(4.8 to 10.3)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG002
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG003
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Units
Counts
Participants
OG000170
OG001194
OG002183
OG003377
Title
Denominators
Categories
Title
Measurements
OG00011.8(8.2 to 16.8)
OG0016.3(3.7 to 10.3)
OG0029.1(6.0 to 13.8)
OG0037.7(5.5 to 10.6)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG002
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG003
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Units
Counts
Participants
OG000114
OG001143
OG002152
OG003295
Title
Denominators
Categories
Title
Measurements
OG00010.6(6.6 to 16.8)
OG0016.0(3.3 to 11.0)
OG0027.9(4.8 to 13.0)
OG0037.0(4.8 to 10.3)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG002
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG003
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Units
Counts
Participants
OG000170
OG001194
OG002183
OG003377
Title
Denominators
Categories
Title
Measurements
OG00019.1(14.6 to 24.9)
OG00110.2(6.9 to 15.0)
OG00215.0(11.0 to 20.4)
OG00312.7(9.9 to 16.1)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG002
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG003
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Units
Counts
Participants
OG000114
OG001143
OG002152
OG003295
Title
Denominators
Categories
Title
Measurements
OG00020.1(14.6 to 27.3)
OG0018.4(5.1 to 13.8)
OG00212.7(8.7 to 18.6)
OG00310.7(7.9 to 14.5)
OG002
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG003
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Units
Counts
Participants
OG000229
OG001231
OG002236
OG003467
Title
Denominators
Categories
Title
Measurements
OG0005.0(4.0 to 6.0)
OG0014.0(4.0 to 5.0)
OG0024.0(3.0 to 5.0)
OG0034.0(4.0 to 5.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.0533
P-value based on stratified log-rank test with the type of background standard-of-care and baseline serostatus as stratification factors.
Superiority
OG000
OG002
Log Rank
0.0411
P-value based on stratified log-rank test with the type of background standard-of-care and baseline serostatus as stratification factors.
Superiority
OG000
OG003
Log Rank
0.0229
P-value based on stratified log-rank test with the type of background standard-of-care and baseline serostatus as stratification factors.
Superiority
OG002
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
OG003
Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).
Units
Counts
Participants
OG000160
OG001172
OG002188
OG003360
Title
Denominators
Categories
Title
Measurements
OG0004.5(4.0 to 6.0)
OG0014.0(3.0 to 5.0)
OG0024.0(3.0 to 4.0)
OG0034.0(3.0 to 4.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Stratified Log Rank Test
0.0218
Superiority
OG000
OG002
Stratified Log Rank Test
0.0156
Superiority
OG000
OG003
Stratified Log Rank Test
0.0067
Superiority
Units
Counts
Participants
OG000730
OG001740
OG002733
OG0031473
Title
Denominators
Categories
Title
Measurements
OG000203
OG001177
OG002181
OG003358
Units
Counts
Participants
OG000730
OG001740
OG002733
OG0031473
Title
Denominators
Categories
Title
Measurements
OG0006
OG00111
OG00215
OG00326
Units
Counts
Participants
OG000730
OG001740
OG002733
OG0031473
Title
Denominators
Categories
Title
Measurements
OG0002
OG0015
OG0027
OG00312
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.
OG003
Phase 3 (Cohort 1): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000mg intravenously on Day 1 in Cohort 1.
OG004
Phase 2: Cohort 1A (Placebo)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.
OG005
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.
OG006
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A
OG007
Phase 2 (Cohort 1A): Combined R10933+R10987 IV
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000mg intravenously on Day 1 in Cohort 1A.
Units
Counts
Participants
OG00070
OG00180
OG00282
OG003162
OG00490
OG00592
OG006106
OG007198
Title
Denominators
Categories
Title
Measurements
OG00017.1(9.2 to 28.0)
OG0018.8(3.6 to 17.2)
OG00217.1(9.7 to 27.0)
OG00313.0(8.2 to 19.1)
OG0044.4(1.2 to 11.0)
OG0053.3(0.7 to 9.2)
OG0060.0(0.0 to 0.0)
OG0071.5(0.3 to 4.4)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.2162
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.8783
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG003
Cochran-Mantel-Haenszel
0.5583
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG004
OG005
Cochran-Mantel-Haenszel
0.7189
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG004
OG006
Cochran-Mantel-Haenszel
0.0429
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG004
OG007
Cochran-Mantel-Haenszel
0.2103
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.
OG003
Phase 3 (Cohort 1): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.
OG004
Phase 2: Cohort 1A (Placebo)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.
OG005
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A
OG006
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.
OG007
Phase 2 (Cohort 1A): Combined R10933+R10987 IV
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.
Units
Counts
Participants
OG00067
OG00179
OG00280
OG003159
OG00486
OG00588
OG006101
OG007189
Title
Denominators
Categories
Title
Measurements
OG00019.4(10.8 to 30.9)
OG0016.3(2.1 to 14.2)
OG00210.0(4.4 to 13.6)
OG0038.2(4.4 to 13.6)
OG0049.3(4.1 to 17.5)
OG0053.4(0.7 to 9.6)
OG0065.0(1.6 to 11.2)
OG0074.2(1.8 to 8.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.0223
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.1256
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG003
Cochran-Mantel-Haenszel
0.0230
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG004
OG005
Cochran-Mantel-Haenszel
0.1298
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG004
OG006
Cochran-Mantel-Haenszel
0.2642
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG004
OG007
Cochran-Mantel-Haenszel
0.0970
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1
OG003
Phase 3 (Cohort 1): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.
OG004
Phase 2: Cohort 1A (Placebo)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.
OG005
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.
OG006
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A
OG007
Phase 2 (Cohort 1A): Combined R10933+R10987 IV
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.
Units
Counts
Participants
OG00070
OG00180
OG00282
OG003162
OG00490
OG00592
OG006106
OG007198
Title
Denominators
Categories
Title
Measurements
OG00022.9(13.7 to 34.4)
OG0017.5(2.8 to 15.6)
OG00211.0(5.1 to 19.8)
OG0039.3(5.3 to 14.8)
OG0048.9(3.9 to 16.8)
OG0053.3(0.7 to 9.2)
OG0065.7(2.1 to 11.9)
OG0074.5(2.1 to 8.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.0147
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.0669
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG003
Cochran-Mantel-Haenszel
0.0094
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG004
OG005
Cochran-Mantel-Haenszel
0.1306
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG004
OG006
Cochran-Mantel-Haenszel
0.3576
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG004
OG007
Cochran-Mantel-Haenszel
0.1476
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.
OG003
Phase 3 (Cohort 1): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.
OG004
Phase 2: Cohort 1A (Placebo)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.
OG005
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.
OG006
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.
OG007
Phase 2 (Cohort 1A): Combined R10933+R10987 IV
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.
Units
Counts
Participants
OG00070
OG00180
OG00282
OG003162
OG00490
OG00592
OG006106
OG007198
Title
Denominators
Categories
Title
Measurements
OG00070.0(57.9 to 80.4)
OG00185.0(75.3 to 92.0)
OG00284.1(74.4 to 91.3)
OG00384.6(78.1 to 89.8)
OG00490.0(81.9 to 95.3)
OG00594.6(87.8 to 98.2)
OG00694.3(88.1 to 97.9)
OG00794.4(90.3 to 97.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.0481
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.0535
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG003
Cochran-Mantel-Haenszel
0.0199
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG004
OG005
Cochran-Mantel-Haenszel
0.2784
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG004
OG006
Cochran-Mantel-Haenszel
0.2510
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG004
OG007
Cochran-Mantel-Haenszel
0.1702
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG002
Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1
OG003
Phase 3 (Cohort 1): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.
OG004
Phase 2: Cohort 1A (Placebo)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.
OG005
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A
OG006
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.
OG007
Phase 2 (Cohort 1A): Combined R10933+R10987 IV
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.
Units
Counts
Participants
OG00070
OG00180
OG00282
OG003162
OG00490
OG00592
OG006106
OG007198
Title
Denominators
Categories
Title
Measurements
OG00027.1(17.2 to 39.1)
OG00113.8(7.1 to 23.3)
OG00214.6(7.8 to 24.2)
OG00314.2(9.2 to 20.5)
OG00422.2(14.1 to 32.2)
OG0059.8(4.6 to 17.8)
OG00611.3(6.0 to 18.9)
OG00710.6(6.7 to 15.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.0500
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.0663
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG003
Cochran-Mantel-Haenszel
0.0229
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG004
OG005
Cochran-Mantel-Haenszel
0.0208
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG004
OG006
Cochran-Mantel-Haenszel
0.0388
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG004
OG007
Cochran-Mantel-Haenszel
0.0092
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG002
Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.
OG003
Phase 3 (Cohort 1): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.
OG004
Phase 2: Cohort 1A (Placebo)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.
OG005
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.
OG006
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A
OG007
Phase 2: Cohort 1A Combined R10933+R10987
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg or 8000 mg) intravenously on Day 1 in Cohort 1A.
Units
Counts
Participants
OG00051
OG00170
OG00270
OG003140
OG00470
OG00578
OG00690
OG007168
Title
Denominators
Categories
Title
Measurements
OG00023.6(15.1 to 35.6)
OG0017.8(3.6 to 16.5)
OG00211.4(6.1 to 20.7)
OG0039.6(5.9 to 15.4)
OG0049.6(4.9 to 18.3)
OG0053.6(1.2 to 10.9)
OG0065.9(2.7 to 12.8)
OG0074.8(2.6 to 9.1)
OG002
Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1
OG003
Phase 3 (Cohort 1): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.
OG004
Phase 2: Cohort 1A (Placebo)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.
OG005
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A
OG006
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A
OG007
Phase 2 (Cohort 1A): Combined R10933+R10987 IV
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.
Units
Counts
Participants
OG00046
OG00166
OG00262
OG003128
OG00468
OG00577
OG00690
OG007167
Title
Denominators
Categories
Title
Measurements
OG00018.2(10.8 to 30.0)
OG0018.9(4.4 to 17.8)
OG00217.6(10.8 to 27.9)
OG00313.4(8.9 to 19.8)
OG0044.7(1.8 to 12.1)
OG0053.5(1.1 to 10.5)
OG0060.0(0.0 to 0.0)
OG0071.7(0.5 to 5.1)
OG002
Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1
OG003
Phase 3 (Cohort 1): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.
OG004
Phase 2: Cohort 1A (Placebo)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.
OG005
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.
OG006
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.
OG007
Phase 2 (Cohort 1A): Combined R10933+R10987 IV
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.
Units
Counts
Participants
OG00046
OG00166
OG00262
OG003128
OG00468
OG00577
OG00690
OG007167
Title
Denominators
Categories
Title
Measurements
OG00030.4(21.0 to 42.7)
OG00112.7(7.0 to 22.3)
OG00221.2(13.8 to 31.9)
OG00317.0(12.0 to 23.8)
OG00411.8(6.5 to 20.8)
OG0054.7(1.8 to 12.1)
OG0065.9(2.7 to 12.8)
OG0075.4(2.9 to 9.7)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.
OG003
Phase 3 (Cohort 1): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.
OG004
Phase 2: Cohort 1A (Placebo)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.
OG005
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A
OG006
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.
OG007
Phase 2 (Cohort 1A): Combined R10933+R10987 IV
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.
Units
Counts
Participants
OG00070
OG00180
OG00282
OG003162
OG00490
OG00586
OG00699
OG007198
Title
Denominators
Categories
Title
Measurements
OG0008.5(5.0 to 15.0)
OG0015.0(4.0 to 7.0)
OG0026.0(4.0 to 9.0)
OG0036.0(4.0 to 7.0)
OG0044.0(3.0 to 4.0)
OG0053.0(2.0 to 4.0)
OG0063.0(2.0 to 4.0)
OG0073.0(2.0 to 4.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
stratified log-rank test
0.0370
Superiority
OG000
OG002
stratified log-rank test
0.1596
Superiority
OG000
OG003
stratified log-rank test
0.0444
Superiority
OG004
OG005
stratified log-rank test
0.1802
Superiority
OG004
OG006
stratified log-rank test
0.0407
Superiority
OG004
OG007
stratified log-rank test
0.0523
Superiority
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.
OG002
Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.
OG003
Phase 3 (Cohort 1): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.
OG004
Phase 2: Cohort 1A (Placebo)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.
OG005
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.
OG006
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.
OG007
Phase 2 (Cohort 1A): Combined R10933+R10987 IV
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.
Units
Counts
Participants
OG00059
OG00176
OG00278
OG003154
OG00480
OG00579
OG00688
OG007167
Title
Denominators
Categories
Title
Measurements
OG000-1.52± 0.17
OG001-2.03± 0.15
OG002-1.95± 0.15
OG003-2.00± 0.10
OG004-1.28± 0.14
OG005-1.88± 0.14
OG006-2.01± 0.14
OG007-1.95± 0.10
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.0245
Superiority
OG000
OG002
ANCOVA
0.0554
Superiority
OG000
OG003
ANCOVA
0.0179
Superiority
OG004
OG005
ANCOVA
0.0035
Superiority
OG004
OG006
ANCOVA
0.0003
Superiority
OG004
OG007
ANCOVA
0.0002
Superiority
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.
OG002
Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.
OG003
Phase 3 (Cohort 1): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.
OG004
Phase 2: Cohort 1A (Placebo)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.
OG005
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.
OG006
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.
OG007
Phase 2 (Cohort 1A): Combined R10933+R10987 IV
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.
Units
Counts
Participants
OG00064
OG00177
OG00279
OG003156
OG00484
OG00582
OG00693
OG007175
Title
Denominators
Categories
Title
Measurements
OG000-2.72± 0.22
OG001-3.68± 0.20
OG002-3.69± 0.20
OG003-3.69± 0.14
OG004-2.66± 0.21
OG005-3.31± 0.21
OG006-3.58± 0.20
OG007-3.45± 0.14
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.0013
Superiority
OG000
OG002
ANCOVA
0.0010
Superiority
OG000
OG003
ANCOVA
0.0002
Superiority
OG004
OG005
ANCOVA
0.0250
Superiority
OG004
OG006
ANCOVA
0.0012
Superiority
OG004
OG007
ANCOVA
0.0014
Superiority
OG002
Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.
OG003
Phase 3 (Cohort 1): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.
OG004
Phase 2: Cohort 1A (Placebo)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.
OG005
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.
OG006
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.
OG007
Phase 2 (Cohort 1A): Combined R10933+R10987 IV
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.
Units
Counts
Participants
OG00070
OG00180
OG00282
OG003162
OG00490
OG00592
OG006106
OG007198
Title
Denominators
Categories
Change at Day 3
ParticipantsOG00051
ParticipantsOG00168
ParticipantsOG00269
ParticipantsOG003137
ParticipantsOG00462
ParticipantsOG00568
ParticipantsOG00676
ParticipantsOG007144
Title
Measurements
OG000-1.10± 0.22
OG001-0.90± 0.19
OG002-0.93± 0.19
OG003
Change at Day 5
ParticipantsOG00046
ParticipantsOG00162
ParticipantsOG00254
ParticipantsOG003116
Change at Day 7
ParticipantsOG00035
ParticipantsOG00150
ParticipantsOG00255
ParticipantsOG003105
Change at Day 9
ParticipantsOG00033
ParticipantsOG00152
ParticipantsOG00249
ParticipantsOG003101
Change at Day 11
ParticipantsOG00031
ParticipantsOG00147
ParticipantsOG00245
ParticipantsOG00392
Change at Day 13
ParticipantsOG00029
ParticipantsOG00145
ParticipantsOG00247
ParticipantsOG00392
Change at Day 15
ParticipantsOG00034
ParticipantsOG00147
ParticipantsOG00251
ParticipantsOG00398
Change at Day 22
ParticipantsOG00028
ParticipantsOG00147
ParticipantsOG00247
ParticipantsOG00394
Change at Day 29
ParticipantsOG00029
ParticipantsOG00152
ParticipantsOG00256
ParticipantsOG003108
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference vs. Placebo by Day 29
MMRM
0.0623
Superiority
OG000
OG002
Difference vs. Placebo by Day 29
MMRM
0.0203
Superiority
OG000
OG003
Difference vs. Placebo by Day 29
MMRM
0.0193
Superiority
OG004
OG005
Difference vs. Placebo by Day 29
MMRM
0.1206
Superiority
OG004
OG006
Difference vs. Placebo by Day 29
MMRM
0.0911
Superiority
OG004
OG007
Difference vs. Placebo by Day 29
MMRM
0.0645
Superiority
OG002
Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.
OG003
Phase 3 (Cohort 1): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.
OG004
Phase 2: Cohort 1A (Placebo)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.
OG005
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.
OG006
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A
OG007
Phase 2 (Cohort 1A): Combined R10933+R10987 IV
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.
Units
Counts
Participants
OG00070
OG00180
OG00282
OG003162
OG00490
OG00592
OG006106
OG007198
Title
Denominators
Categories
Percent change at Day 3
ParticipantsOG00051
ParticipantsOG00168
ParticipantsOG00269
ParticipantsOG003137
ParticipantsOG00462
ParticipantsOG00568
ParticipantsOG00676
ParticipantsOG007144
Title
Measurements
OG000-92.04(-97.12 to -78.01)
OG001-87.52(-94.82 to -69.93)
OG002-88.15(-95.07 to -71.52)
OG003
Percent change at Day 5
ParticipantsOG00046
ParticipantsOG00162
ParticipantsOG00254
ParticipantsOG003116
Percent change at Day 7
ParticipantsOG00035
ParticipantsOG00150
ParticipantsOG00255
ParticipantsOG003105
Percent change at Day 9
ParticipantsOG00033
ParticipantsOG00152
ParticipantsOG00249
ParticipantsOG003101
Percent change at Day 11
ParticipantsOG00031
ParticipantsOG00147
ParticipantsOG00245
ParticipantsOG00392
Percent change at Day 13
ParticipantsOG00029
ParticipantsOG00145
ParticipantsOG00247
ParticipantsOG00392
Percent change at Day 15
ParticipantsOG00034
ParticipantsOG00147
ParticipantsOG00251
ParticipantsOG00398
Percent change at Day 22
ParticipantsOG00028
ParticipantsOG00147
ParticipantsOG00247
ParticipantsOG00394
Percent change at Day 29
ParticipantsOG00029
ParticipantsOG00152
ParticipantsOG00256
ParticipantsOG003108
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Percent Difference vs. Placebo at Day 29
MMRM
0.0623
Superiority
OG000
OG002
Percent Difference vs. Placebo at Day 29
MMRM
0.0203
Superiority
OG000
OG003
Percent Difference vs. Placebo at Day 29
MMRM
0.0193
Superiority
OG004
OG005
Percent Difference vs. Placebo at Day 29
MMRM
0.1206
Superiority
OG004
OG006
Percent Difference vs. Placebo at Day 29
MMRM
0.0911
Superiority
OG004
OG007
Percent Difference vs. Placebo at Day 29
MMRM
0.0645
Superiority
Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.
OG003
Phase 3 (Cohort 1): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.
OG004
Phase 2: Cohort 1A (Placebo)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.
OG005
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A
OG006
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.
OG007
Phase 2 (Cohort 1A): Combined R10933+R10987 IV
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.
Units
Counts
Participants
OG000126
OG001129
OG002118
OG003247
OG004103
OG005102
OG006118
OG007220
Title
Denominators
Categories
Title
Measurements
OG00017.5(11.3 to 25.2)
OG0018.5(4.3 to 14.7)
OG00216.9(10.7 to 25.0)
OG00312.6(8.7 to 17.3)
OG0043.9(1.1 to 9.6)
OG0052.9(0.6 to 8.4)
OG0060.0(0.0 to 0.0)
OG0071.4(0.3 to 3.9)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.0481
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.9880
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG003
Cochran-Mantel-Haenszel
0.2498
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG004
OG005
Cochran-Mantel-Haenszel
1.0000
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG004
OG006
Cochran-Mantel-Haenszel
0.0457
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG004
OG007
Cochran-Mantel-Haenszel
0.2153
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.
OG003
Phase 3 (Cohort 1): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.
OG004
Phase 2: Cohort 1A (Placebo)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.
OG005
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A
OG006
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.
OG007
Phase 2 (Cohort 1A): Combined R10933+R10987 IV
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.
Units
Counts
Participants
OG000122
OG001128
OG002115
OG003243
OG004100
OG00598
OG006113
OG007211
Title
Denominators
Categories
Title
Measurements
OG00018.0(11.7 to 26.0)
OG00110.2(5.5 to 16.7)
OG00215.7(9.5 to 23.6)
OG00312.8(8.8 to 17.6)
OG0047.0(2.9 to 13.9)
OG0053.1(0.6 to 8.7)
OG0064.4(1.5 to 10.0)
OG0073.8(1.7 to 7.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.0811
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.6701
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG003
Cochran-Mantel-Haenszel
0.2006
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG004
OG005
Cochran-Mantel-Haenszel
0.3313
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG004
OG006
Cochran-Mantel-Haenszel
0.5542
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG004
OG007
Cochran-Mantel-Haenszel
0.2214
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.
OG003
Phase 3 (Cohort 1): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.
OG004
Phase 2: Cohort 1A (Placebo)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.
OG005
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.
OG006
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.
OG007
Phase 2 (Cohort 1A): Combined R10933+R10987 IV
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.
Units
Counts
Participants
OG000126
OG001129
OG002118
OG003247
OG004103
OG005102
OG006118
OG007220
Title
Denominators
Categories
Title
Measurements
OG00020.6(13.9 to 28.8)
OG00110.9(6.1 to 17.5)
OG00216.9(10.7 to 25.0)
OG00313.8(9.7 to 18.7)
OG0046.8(2.8 to 13.5)
OG0052.9(0.6 to 8.4)
OG0065.1(1.9 to 10.7)
OG0074.1(1.9 to 7.6)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.0389
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.5208
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG003
Cochran-Mantel-Haenszel
0.1079
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG004
OG005
Cochran-Mantel-Haenszel
0.3315
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG004
OG006
Cochran-Mantel-Haenszel
0.5797
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG004
OG007
Cochran-Mantel-Haenszel
0.3036
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.
OG003
Phase 3 (Cohort 1): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.
OG004
Phase 2: Cohort 1A (Placebo)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.
OG005
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.
OG006
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.
OG007
Phase 2 (Cohort 1A): Combined R10933+R10987 IV
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.
Units
Counts
Participants
OG000126
OG001129
OG002118
OG003247
OG004103
OG005102
OG006118
OG007220
Title
Denominators
Categories
Title
Measurements
OG00072.2(63.5 to 79.8)
OG00183.7(76.2 to 89.6)
OG00278.8(70.3 to 85.8)
OG00381.4(76.0 to 86.0)
OG00490.3(82.9 to 95.2)
OG00596.1(90.3 to 98.9)
OG00694.9(89.3 to 98.1)
OG00795.5(91.8 to 97.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.0364
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.2795
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG003
Cochran-Mantel-Haenszel
0.0588
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG004
OG005
Cochran-Mantel-Haenszel
0.0364
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG004
OG006
Cochran-Mantel-Haenszel
0.2795
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG004
OG007
Cochran-Mantel-Haenszel
0.0588
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG002
Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.
OG003
Phase 3 (Cohort 1): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.
OG004
Phase 2: Cohort 1A (Placebo)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.
OG005
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.
OG006
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.
OG007
Phase 2 (Cohort 1A): Combined R10933+R10987 IV
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.
Units
Counts
Participants
OG000126
OG001129
OG002118
OG003247
OG004103
OG005102
OG006118
OG007220
Title
Denominators
Categories
Title
Measurements
OG00024.6(17.4 to 33.1)
OG00118.6(12.3 to 26.4)
OG00222.9(15.7 to 31.5)
OG00320.6(15.8 to 26.2)
OG00416.5(9.9 to 25.1)
OG00510.8(5.5 to 18.5)
OG00611.9(6.6 to 19.1)
OG00711.4(7.5 to 16.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.2635
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.8013
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG000
OG003
Cochran-Mantel-Haenszel
0.4160
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG004
OG005
Cochran-Mantel-Haenszel
0.2194
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG004
OG006
Cochran-Mantel-Haenszel
0.3240
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG004
OG007
Cochran-Mantel-Haenszel
0.1981
P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.
Superiority
OG002
Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.
OG003
Phase 3 (Cohort 1): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.
OG004
Phase 2: Cohort 1A (Placebo)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.
OG005
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.
OG006
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.
OG007
Phase 2 (Cohort 1A): Combined R10933+R10987 IV
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.
Units
Counts
Participants
OG00096
OG001110
OG00290
OG003200
OG00485
OG00591
OG006100
OG007191
Title
Denominators
Categories
Title
Measurements
OG00021.1(14.9 to 29.4)
OG00111.2(6.8 to 18.2)
OG00217.9(11.9 to 26.3)
OG00314.3(10.5 to 19.5)
OG0047.2(3.5 to 14.4)
OG0053.1(1.0 to 9.4)
OG0065.3(2.4 to 11.5)
OG0074.3(2.3 to 8.2)
OG002
Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.
OG003
Phase 3 (Cohort 1): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.
OG004
Phase 2: Cohort 1A (Placebo)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.
OG005
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.
OG006
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A
OG007
Phase 2 (Cohort 1A): Combined R10933+R10987 IV
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.
Units
Counts
Participants
OG00087
OG001104
OG00283
OG003187
OG00483
OG00590
OG006100
OG007190
Title
Denominators
Categories
Title
Measurements
OG00018.1(12.3 to 26.2)
OG0018.8(5.0 to 15.3)
OG00218.0(12.0 to 26.5)
OG00313.1(9.4 to 18.1)
OG0044.0(1.5 to 10.4)
OG0053.1(1.0 to 9.2)
OG0060.0(0.0 to 0.0)
OG0071.5(0.5 to 4.5)
OG002
Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.
OG003
Phase 3 (Cohort 1): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.
OG004
Phase 2: Cohort 1A (Placebo)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.
OG005
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.
OG006
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.
OG007
Phase 2 (Cohort 1A): Combined R10933+R10987 IV
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.
Units
Counts
Participants
OG00087
OG001104
OG00283
OG003187
OG00483
OG00590
OG006100
OG007190
Title
Denominators
Categories
Title
Measurements
OG00027.2(20.2 to 35.9)
OG00115.0(9.8 to 22.5)
OG00224.4(17.6 to 33.4)
OG00319.5(15.0 to 25.1)
OG0049.1(4.9 to 16.8)
OG0054.1(1.6 to 10.5)
OG0065.3(2.4 to 11.5)
OG0074.8(2.6 to 8.7)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.
OG003
Phase 3 (Cohort 1): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.
OG004
Phase 2: Cohort 1A (Placebo)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.
OG005
Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.
OG006
Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.
OG007
Phase 2 (Cohort 1A): Combined R10933+R10987 IV
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.
Units
Counts
Participants
OG000126
OG001129
OG002118
OG003247
OG004103
OG005102
OG006118
OG007220
Title
Denominators
Categories
Title
Measurements
OG0007.0(5.0 to 10.0)
OG0017.0(5.0 to 8.0)
OG0027.0(5.0 to 8.0)
OG0037.0(6.0 to 8.0)
OG0044.0(3.0 to 4.0)
OG0053.0(2.0 to 4.0)
OG0063.0(2.0 to 3.0)
OG0073.0(3.0 to 3.0)
OG002
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1
OG003
Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 Combined IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1
Units
Counts
Participants
OG00068
OG00179
OG00270
OG003149
Title
Denominators
Categories
Time-weighted average change from baseline from Day 1 to Day 3
ParticipantsOG00055
ParticipantsOG00152
ParticipantsOG00246
ParticipantsOG00398
Title
Measurements
OG000-0.33± 0.11
OG001-0.40± 0.11
OG002-0.60± 0.12
OG003
Time-weighted average change from baseline from Day 1 to Day 5
ParticipantsOG00058
ParticipantsOG00157
ParticipantsOG00252
ParticipantsOG003
Time-weighted average change from baseline from Day 1 to Day 7
ParticipantsOG00061
ParticipantsOG00160
ParticipantsOG00255
ParticipantsOG003
Time-weighted average change from baseline from Day 1 to Day 9
ParticipantsOG00061
ParticipantsOG00161
ParticipantsOG00257
ParticipantsOG003
Time-weighted average change from baseline from Day 1 to Day 11
ParticipantsOG00061
ParticipantsOG00163
ParticipantsOG00258
ParticipantsOG003
Time-weighted average change from baseline from Day 1 to Day 13
ParticipantsOG00061
ParticipantsOG00164
ParticipantsOG00258
ParticipantsOG003
Time-weighted average change from baseline from Day 1 to Day 15
ParticipantsOG00061
ParticipantsOG00164
ParticipantsOG00258
ParticipantsOG003
Time-weighted average change from baseline from Day 1 to Day 22
ParticipantsOG00061
ParticipantsOG00164
ParticipantsOG00258
ParticipantsOG003
Time-weighted average change from baseline from Day 1 to Day 29
ParticipantsOG00061
ParticipantsOG00164
ParticipantsOG00258
ParticipantsOG003
OG002
Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1
OG003
Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 Combined IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1
Units
Counts
Participants
OG00068
OG00179
OG00270
OG003149
Title
Denominators
Categories
Time-weighted average change from baseline from Day 1 to Day 3
ParticipantsOG00055
ParticipantsOG00152
ParticipantsOG00246
ParticipantsOG00398
Title
Measurements
OG000-0.66± 0.22
OG001-0.81± 0.21
OG002-1.08± 0.23
OG003
Time-weighted average change from baseline from Day 1 to Day 5
ParticipantsOG00047
ParticipantsOG00143
ParticipantsOG00240
ParticipantsOG003
Time-weighted average change from baseline from Day 1 to Day 7
ParticipantsOG00036
ParticipantsOG00143
ParticipantsOG00237
ParticipantsOG003
Time-weighted average change from baseline from Day 1 to Day 9
ParticipantsOG00027
ParticipantsOG00132
ParticipantsOG00231
ParticipantsOG003
Time-weighted average change from baseline from Day 1 to Day 11
ParticipantsOG00031
ParticipantsOG00130
ParticipantsOG00233
ParticipantsOG003
Time-weighted average change from baseline from Day 1 to Day 13
ParticipantsOG00025
ParticipantsOG00131
ParticipantsOG00223
ParticipantsOG003
Time-weighted average change from baseline from Day 1 to Day 15
ParticipantsOG00021
ParticipantsOG00127
ParticipantsOG00226
ParticipantsOG003
Time-weighted average change from baseline from Day 1 to Day 22
ParticipantsOG00018
ParticipantsOG00128
ParticipantsOG00226
ParticipantsOG003
Time-weighted average change from baseline from Day 1 to Day 29
ParticipantsOG00019
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG003
OG003
Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of 2400mg or 8000 mg R10933+R10987 intravenously on Day 1
Units
Counts
Participants
OG00052
OG00162
OG00259
OG003121
Title
Denominators
Categories
Title
Measurements
OG00026.9(19.0 to 34.8)
OG00117.7(11.5 to 24.0)
OG00222.0(15.1 to 28.9)
OG00319.8(15.2 to 24.5)
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1
OG003
Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of 2400mg or 8000 mg R10933+R10987 intravenously on Day 1
Units
Counts
Participants
OG00078
OG00177
OG00280
OG003157
Title
Denominators
Categories
Title
Measurements
OG00023.1(17.0 to 29.2)
OG00123.4(17.2 to 29.6)
OG00213.8(8.8 to 18.7)
OG00318.5(14.5 to 22.4)
16
OG00120
Title
Denominators
Categories
AUC0-28 of Casirivimab
ParticipantsOG0009
ParticipantsOG00112
Title
Measurements
OG0003026± 719
OG0019678± 3362
AUC0-28 of Imdevimab
ParticipantsOG0009
ParticipantsOG00114
Title
Measurements
OG0002582± 581
OG001
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1A).
OG004
Phase 2 (Cohort 1): R10933+R10987 2400mg IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1).
OG005
Phase 2 (Cohort 1): R10933+R10987 8000mg IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1).
OG006
Phase 2 (Cohort 2): R10933+R10987 2400mg IV
Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 2).
OG007
Phase 2 (Cohort 2): R10933+R10987 8000mg IV
Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 2).
OG008
Phase 2 (Cohort 3): R10933+R10987 2400mg IV
Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).
OG009
Phase 2 (Cohort 3): R10933+R10987 8000mg IV
Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).
OG010
Phase 3 (Cohort 1): R10933+R10987 2400mg IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 3 (Cohort 1).
OG011
Phase 3 (Cohort 1): R10933+R10987 8000mg IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 3 (Cohort 1).
Units
Counts
Participants
OG00016
OG00120
OG002167
OG003155
OG004181
OG005178
OG00655
OG00750
OG00810
OG00911
OG010214
OG011207
Title
Denominators
Categories
Ceoi of Casirivimab
ParticipantsOG00015
ParticipantsOG00120
ParticipantsOG002167
ParticipantsOG003155
ParticipantsOG004181
ParticipantsOG005178
ParticipantsOG00655
ParticipantsOG00750
ParticipantsOG00810
ParticipantsOG00911
ParticipantsOG010214
ParticipantsOG011207
Title
Measurements
OG000231± 110
OG001776± 372
OG002272± 124
OG003
Ceoi of Imdevimab
ParticipantsOG00015
ParticipantsOG00120
ParticipantsOG002167
ParticipantsOG003155
Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1A).
OG004
Phase 2 (Cohort 1): R10933+R10987 2400mg IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1).
OG005
Phase 2 (Cohort 1): R10933+R10987 8000mg IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1).
OG006
Phase 2 (Cohort 2): R10933+R10987 2400mg IV
Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 2).
OG007
Phase 2 (Cohort 2): R10933+R10987 8000mg IV
Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 2).
OG008
Phase 2 (Cohort 3): R10933+R10987 2400mg IV
Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).
OG009
Phase 2 (Cohort 3): R10933+R10987 8000mg IV
Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).
OG010
Phase 3 (Cohort 1): R10933+R10987 2400mg IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 3 (Cohort 1).
OG011
Phase 3 (Cohort 1): R10933+R10987 8000mg IV
Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 3 (Cohort 1).