Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS... | NCT04425629 | Trialant
NCT04425629
Sponsor
Regeneron Pharmaceuticals
Status
Terminated
Last Update Posted
Dec 21, 2023Actual
Enrollment
10,078Actual
Phase
Phase 3
Conditions
COVID-19
Interventions
casirivimab+imdevimab combination therapy
Countries
United States
Mexico
Romania
Protocol Section
Identification Module
NCT ID
NCT04425629
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
R10933-10987-COV-2067
Secondary IDs
ID
Type
Description
Link
2020-003690-21
EudraCT Number
Brief Title
Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult and Pediatric 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 Ambulatory Patients With COVID-19
Acronym
Not provided
Organization
Regeneron PharmaceuticalsINDUSTRY
Status Module
Record Verification Date
Dec 2023
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Emerging SARS-CoV-2 variants impacting susceptibility to study drug
Expanded Access Info
YesNCT04617535No longer available
Start Date
Jun 16, 2020Actual
Primary Completion Date
Jan 21, 2022Actual
Completion Date
Jun 9, 2022Actual
First Submitted Date
Jun 8, 2020
First Submission Date that Met QC Criteria
Jun 8, 2020
First Posted Date
Jun 11, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Jan 20, 2023
Results First Submitted that Met QC Criteria
Dec 20, 2023
Results First Posted Date
Dec 21, 2023Actual
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
Dec 20, 2023
Last Update Posted Date
Dec 21, 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
Phase 1
To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo
To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2
Phase 2
• To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2
Phase 3
Cohort 1 (≥18 Years Old, Not Pregnant at Randomization)
• To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo as measured by COVID-19-related hospitalizations or all-cause death
Cohort 2 (<18 Years Old, Not Pregnant at Randomization)
To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo
To further characterize the concentrations of REGN10933 and REGN10987 in serum over time
Cohort 3 (Pregnant at Randomization) • To evaluate the safety and tolerability of REGN10933+REGN10987
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
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
10,078Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
casirivimab+imdevimab low dose
Experimental
Low dose or body-weight equivalent for those under 18 years of age.
Drug: casirivimab+imdevimab combination therapy
Interventions
Name
Type
Description
Arm Group Labels
Other Names
casirivimab+imdevimab combination therapy
Drug
Administered intravenously (IV) single dose
casirivimab+imdevimab low dose
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) - [Ph1, Ph2, Ph3 Cohort 1 - Cohort 3]
Primary:
Phase 1, Phase 3 (Cohort 2 and Cohort 3)
Secondary:
Phase 2, Phase 3 (Cohort 1)
Through Day 29
Number of Participants With Infusion-related Reactions (Ph1, Ph2, Ph3 Cohort 1 - Cohort 3)
Primary:
Phase 1, Phase 3 (Cohort 2 and Cohort 3)
Secondary:
Phase 2, Phase 3 (Cohort 1)
Through Day 4
Number of Participants With Hypersensitivity Reactions (Ph1, Ph2, Ph3 Cohort 1 - Cohort 3)
Primary:
Phase 1, Phase 3 (Cohort 2 and Cohort 3)
Secondary:
Phase 2, Phase 3 (Cohort 1)
Through Day 29
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) From Day 1 to Day 7, as Measured by Quantitative Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) in Nasopharyngeal (NP) Swab Samples (Ph1, Ph2)
Primary:
Phase 1, Phase 2
Baseline up to Day 7
Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Ph3 Cohort 1- 1.2g vs Placebo)
Phase 3 Cohort 1
Through Day 29
Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Ph3 Cohort 1 - 2.4g vs Placebo)
Primary:
Phase 3 (Cohort 1)
Through Day 29
Concentration of REGN10983 + REGN10987 in Serum Over Time (Ph3 Cohort 2)
Secondary Outcomes
Measure
Description
Time Frame
Time to COVID-19 Symptoms Resolution (Ph3 Cohort 1 - 1.2g vs Placebo)
Phase 3 Cohort 1
Up to Day 29
Time to COVID-19 Symptoms Resolution (Ph3 Cohort 1 - 2.4g vs Placebo)
Phase 3 (Cohort 1)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Has SARS-CoV-2-positive diagnostic test (from a sample collected ≤72 hours prior to randomization, using a validated SARS-CoV-2 antigen, RT-PCR, or other molecular diagnostic assay, and an appropriate sample such as nasopharyngeal [NP], nasal, oropharyngeal [OP], or saliva)
Has symptoms consistent with COVID-19, as determined by the investigator, with onset ≤7 days before randomization
Maintains O2 saturation ≥93% on room air
Is able to understand and complete study-related questionnaires (patients aged ≥12 years only)
Key Exclusion Criteria:
Was admitted to a hospital for COVID-19 prior to randomization, or is hospitalized (inpatient) for any reason at randomization
Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, mAbs against SARS-CoV-2 (eg, bamlanivimab), or intravenous immunoglobulin (IVIG) within 3 months or within 5 half-lives of the investigational product (whichever is longer) prior to the screening visit
Prior, current, or planned future use of any of the following treatments: COVID-19 convalescent plasma, mAbs against SARS-CoV-2 (eg, bamlanivimab), IVIG (any indication), systemic corticosteroids (any indication), or COVID-19 treatments (authorized, approved, or investigational)
Prior use (prior to randomization), current use (at randomization) or planned use (within 90 days of study drug administration or per current CDC recommendations, as applicable) of any authorized or approved vaccine for COVID-19
Has participated, is participating or plans to participate in a clinical research study evaluation any authorized, approved or investigational vaccine for COVID-19
NOTE: Other Protocol defined Inclusion/Exclusion criteria apply
Norton TD, Thakur M, Ganguly S, Ali S, Chao J, Waldron A, Xiao J, Patel Y, Turner KC, Davis JD, Irvin SC, Pan C, Atmodjo-Watkins D, Hooper AT, Hamilton JD, Subramaniam D, Bocchini JA, Kowal B, DiCioccio AT, Bhore R, Geba GP, Cox E, Braunstein N, Dakin P, Herman GA. Assessing the safety and pharmacokinetics of casirivimab and imdevimab (CAS+IMD) in a cohort of pregnant outpatients with COVID-19: results from an adaptive, multicentre, randomised, double-blind, phase 1/2/3 study. BMJ Open. 2024 Oct 8;14(10):e087431. doi: 10.1136/bmjopen-2024-087431.
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).
(TE&TB+;NAb+) = TE = Treatment-emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay
Through Day 29
Number of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Phase 3 Cohort 2)
Phase 3 (Cohort 2)
Through Day 29
Percentage of Participants With ≥1 COVID-19-related Medically-attended Visit (Phase 1, Phase 2)
Phase 1, Phase 2 Medically-attended Visits include Hospitalizations, ER visits, Urgent Care Clinic visits, Outpatient/physician office/telemedicine visits
Through Day 29
Percentage of Participants With ≥2 COVID-19-related Medically-attended Visit - (Ph3 Cohort 1) - Placebo vs. 1.2g IV
Phase 3 (Cohort 1)
Through Day 29
Percentage of Participants With ≥2 COVID-19-related Medically-attended Visit - (Ph3 Cohort 1) - Placebo vs. 2.4g IV
Phase 3 Cohort 1
Through Day 29
Total Number of COVID-19-related Medically-attended Visits (Phase 1 and Phase 2)
Phase 1 and Phase 2
Through Day 29
Assessment of Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of REGN10933 and REGN10987 (Phase 1 Only)
Phase 1 Only
Through Day 29
Assessment of PK Parameter: Cmax-to-dose Ratio (Cmax/Dose) of REGN10933 and REGN10987 (Phase 1 Only)
Phase 1 Only
Though Day 29
Assessment of PK Parameter: Time to Cmax (Tmax) for REGN10933 and REGN10987 (Phase 1 Only)
Phase 1 Only
Through Day 29
Assessment of PK Parameter: Area Under the Curve (AUC) Computed From Time Zero to the Time of the Last Positive Concentration (AUClast) for REGN10933 - (Phase 1 Only)
Phase 1 Only - Tlast (Time of last quantifiable concentration)
Through Day 29
Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Phase 3 Cohort 1
Day 4 Through Day 29
Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Phase 3 Cohort 1
Day 4 Through Day 29
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Phase 3 Cohort 1
Through Day 29
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Phase 3 Cohort 1
Through Day 29
Number of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Phase 3 Cohort 2)
Phase 3 (Cohort 2)
Through Day 29
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit by Type of Visit Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Phase 3 Cohort 1
Through Day 29
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit by Type of Visit Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Phase 3 Cohort 1
Through Day 29
Total Number of COVID-19-related Medically-attended Visits by Type of Visit Through Day 29 (Phase 3 Cohort 2)
Phase 3 (Cohort 2)
Through Day 29
Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Phase 3 Cohort 1
Through Day 29
Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Phase 3 Cohort 1
Through Day 29
Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization, Emergency Room (ER) or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Phase 3 Cohort 1
Through Day 29
Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization, Emergency Room (ER) or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Phase 3 Cohort 1
Through Day 29
Cumulative Incidence Percentage of Patients With COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Phase 3 Cohort 1
Through Day 29
Cumulative Incidence Percentage of Patients With COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Phase 3 Cohort 1
Through Day 29
Proportion of Participants Requiring Supplemental Oxygen Due to COVID-19 by Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Phase 3 Cohort 1
Through Day 29
Proportion of Participants Requiring Supplemental Oxygen Due to COVID-19 by Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Phase 3 Cohort 1
Through Day 29
Percentage of Participants With All-Cause Death (Ph3 Cohort 1) Placebo vs. 1.2g
Phase 3 Cohort 1
by Day 29, Day 120, and Day 169
Percentage of Participants With All-Cause Death (Ph3 Cohort 1) Placebo vs. 2.4g
Phase 3 Cohort 1 Placebo vs. 2.4g IV
by Day 29, Day 120, and Day 169
Proportion of Participants With High Viral Load at Each Visit - (Phase 2 Only)
Next Phase 2 Only
Through Day 29
Correlation of RT-qPCR Results Over Time Between Different Sample Types (NP, Nasal, and Saliva) - (Phase 1 Only)
Phase 1 Only
Up to Day 29
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasal Swabs - (Phase 1 Only)
Phase 1 Only
Baseline Up To Day 29
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Saliva Samples - (Phase 1 Only)
Phase 1 Only
Baseline Up to Day 29
Concordance of RT-qPCR Results Over Time Between Different Sample Types (NP, Nasal, and Saliva) - (Phase 1 Only)
Phase 1 Only
Up To Day 29
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL), as Measured by RT-qPCR in Saliva Samples - (Phase 1)
Phase 1 Only
Baseline up to Day 22
Number of Participants With Viral Loads Below the Limit of Detection at Each Visit - (Phase 2 Only)
Phase 2 Only
Through Day 29
Duration of Symptoms Consistent With COVID-19 (Phase 2 Only)
Phase 2 Only
Through Day 29
Time to First Onset of Symptoms Consistent With COVID-19 (Phase 2 Asymptomatic Cohort Only)
Phase 2 Only
Through Day 29
Number of Participants Admitted to a Hospital Due to COVID-19 (Phase 1, Phase 2)
Phase 1, Phase 2
Through Day 29
Time to Negative RT-qPCR in All Tested Samples With no Subsequent Positive RT-qPCR in Any Tested Samples - (Phase 1 Only)
Phase 1 Only
Through Day 29
Proportion of Participants With All-cause Mortality (Phase 2 Asymptomatic)
Phase 2 Asymptomatic
Through Day 29
Time to All-cause Death (Ph3 Cohort 1- 1.2g vs Placebo)
Phase 3 Cohort 1 (1.2g IV)
Through Day 169
Time to All-cause Death (Ph3 Cohort 1- 2.4g vs Placebo)
Phase 3 Cohort 1 (2.4g IV)
Through Day 169
Time to All-cause Death (Phase 3 Cohort 2)
Phase 3 (Cohort 2)
Through Day 29
Proportion of Participants Requiring Mechanical Ventilation Due to COVID-19 (Ph3 Cohort 1- 1.2g vs Placebo)
Through Day 29
Proportion of Participants Requiring Mechanical Ventilation Due to COVID-19 (Ph3 Cohort 1- 2.4g vs Placebo)
Through Day 29
Proportion of Participants Requiring Mechanical Ventilation Due to COVID-19 (Phase 3 Cohort 2)
Phase 3 (Cohort 2)
Through Day 29
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 1 - 1.2g vs. Placebo)
Phase 3 Cohort 1
Baseline up to Day 29
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 1 - 2.4g vs. Placebo)
Phase 3 Cohort 1
Baseline up to Day 29
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 2)
Phase 3 Cohort 2
Baseline up to Day 29
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL), as Measured by Quantitative Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) in Nasopharyngeal (NP) Swab Samples (Ph3 Cohort 1)
Phase 3 (Cohort 1)
Baseline to Day 7
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL), as Measured by Quantitative Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) in Nasopharyngeal (NP) Swab Samples (Ph3 Cohort 2)
Phase 3 (Cohort 2)
Baseline to Day 7
Proportion of Participants With Viral Loads Below the Lower Limit of Detection at Each Visit - (Phase 2 Only)
Next Phase 2 Symptomatic
Day 0, Day 5, Day 7, Day 15, Day 29
Proportion of Participants With Viral Loads Below the Lower Limit of Quantitation at Each Visit - (Phase 2 Only)
Next Phase 2 Symptomatic
Day 0, Day 5, Day 7, Day 15, Day 29
Number of Days of Hospitalization Due to COVID-19 (Ph3 Cohort 1) Placebo vs. 1.2g IV
Phase 3 (Cohort 1)
Through Day 29
Number of Days of Hospitalization Due to COVID-19 (Ph3 Cohort 1) Placebo vs. 2.4g IV
Phase 3 (Cohort 1)
Through Day 29
Number of Days of Hospitalization Due to COVID-19 (Ph3 Cohort 2)
Phase 3 (Cohort 2)
Through Day 29
Number of Days of Hospitalization Due to COVID-19 (Phase 2 Asymptomatic)
Phase 2 Only
Up to Day 29
Proportion of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Ph 3 Cohort 1) Placebo vs. 1.2g IV
Phase 3 (Cohort 1)
Through Day 29
Percentage of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Ph 3 Cohort 1) Placebo vs. 2.4g IV
Phase 3 (Cohort 1)
Through Day 29
Proportion of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Ph 3 Cohort 2)
Phase 3 (Cohort 2)
Through Day 29
Proportion of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Next Phase 2) #87
Next Phase 2
Through Day 29
Total Number of COVID-19-related Medically-attended Visits (Phase 3 Cohort 1) Placebo vs. 1.2g
Phase 3 Cohort 1
Through Day 29
Total Number of COVID-19-related Medically-attended Visits (Phase 3 Cohort 1) Placebo vs. 2.4g
Phase 3 Cohort 1
Through Day 29
Total Number of COVID-19-related Medically-attended Visits (Phase 3 Cohort 2)
Phase 3 Cohort 2
Through Day 29
Tucson
Arizona
85712
United States
Regeneron Study Site
Tucson
Arizona
85724
United States
Regeneron Study Site
Canoga Park
California
91303
United States
Regeneron Study Site
La Mesa
California
91942
United States
Regeneron Study Site
La Palma
California
90623
United States
Regeneron Study Site 1
Long Beach
California
90806
United States
Regeneron Study Site 2
Long Beach
California
90806
United States
Regeneron Study Site 3
Long Beach
California
90806
United States
Regeneron Study Site
Los Angeles
California
90036
United States
Regeneron Study Site
Montclair
California
91763
United States
Regeneron Study Site
Rolling Hills Estates
California
90274
United States
Regeneron Study Site
Sacramento
California
95817
United States
Regeneron Study Site
San Francisco
California
94127
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
Colorado Springs
Colorado
80907
United States
Regeneron Study Site
Washington D.C.
District of Columbia
20037
United States
Regeneron Study Site
Boca Raton
Florida
33487
United States
Regeneron Study Site
DeLand
Florida
32720
United States
Regeneron Study Site
Ft. Pierce
Florida
34982
United States
Regeneron Study Site
Hialeah
Florida
33010
United States
Regeneron Study Site
Loxahatchee Groves
Florida
33470
United States
Regeneron Study Site
Maitland
Florida
32751
United States
Regeneron Study Site
Miami
Florida
33012
United States
Regeneron Study Site 1
Miami
Florida
33126
United States
Regeneron Study Site 2
Miami
Florida
33126
United States
Regeneron Study Site
Miami
Florida
33130
United States
Regeneron Study Site
Miami
Florida
33144
United States
Regeneron Study Site
Miami
Florida
33184
United States
Regeneron Study Site
Sarasota
Florida
34239
United States
Regeneron Study Site
St. Petersburg
Florida
33705
United States
Regeneron Study Site
Tampa
Florida
33606
United States
Regeneron Study Site
West Palm Beach
Florida
33407
United States
Regeneron Study Site
Winter Haven
Florida
33880
United States
Regeneron Study Site
Winter Park
Florida
32789
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
Columbus
Georgia
31904
United States
Regeneron Study Site
Marietta
Georgia
30060
United States
Regeneron Study Site
Chicago
Illinois
60607
United States
Regeneron Study Site 1
Downers Grove
Illinois
60515
United States
Regeneron Study Site 2
Downers Grove
Illinois
60515
United States
Regeneron Study Site
Downers Grove
Illinois
60515
United States
Regeneron Study Site
Ames
Iowa
50010-3014
United States
Regeneron Study Site
Iowa City
Iowa
52242
United States
Regeneron Study Site
Lake Charles
Louisiana
70601
United States
Regeneron Study Site
Marrero
Louisiana
70072
United States
Regeneron Study Site
New Orleans
Louisiana
70114
United States
Regeneron Study Site
Shreveport
Louisiana
71118
United States
Regeneron Study Site
Baltimore
Maryland
21201
United States
Regeneron Study Site
Royal Oak
Michigan
48073
United States
Regeneron Study Site
Jackson
Mississippi
39216
United States
Regeneron Study Site
Las Vegas
Nevada
89109
United States
Regeneron Study Site
Ridgewood
New Jersey
07450
United States
Regeneron Study Site
Teaneck
New Jersey
07666
United States
Regeneron Study Site
Santa Fe
New Mexico
87505
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
The Bronx
New York
10451
United States
Regeneron Study Site
The Bronx
New York
10461
United States
Regeneron Study Site
Charlotte
North Carolina
28209
United States
Regeneron Study Site
Durham
North Carolina
27710
United States
Regeneron Study Site
Wilmington
North Carolina
28401
United States
Regeneron Study Site
Columbus
Ohio
43215
United States
Regeneron Study Site
Dayton
Ohio
45409
United States
Regeneron Study Site
Dayton
Ohio
45432
United States
Regeneron Study Site
Philadelphia
Pennsylvania
19140
United States
Regeneron Study Site
Providence
Rhode Island
02903
United States
Regeneron Study Site
Charleston
South Carolina
29425
United States
Regeneron Study Site
Clinton
South Carolina
29325
United States
Regeneron Study Site
Sioux Falls
South Dakota
57108
United States
Regeneron Study Site 2
Memphis
Tennessee
38103
United States
Regeneron Study Site
Memphis
Tennessee
38103
United States
Regeneron Study Site
Amarillo
Texas
79109
United States
Regeneron Study Site
Corpus Christi
Texas
78413
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
77008
United States
Regeneron Study Site
Houston
Texas
77030
United States
Regeneron Study Site
Houston
Texas
77055
United States
Regeneron Study Site
Houston
Texas
77057
United States
Regeneron Study Site
Houston
Texas
77093
United States
Regeneron Study Site
Pearland
Texas
77584
United States
Regeneron Study Site
Red Oak
Texas
75154
United States
Regeneron Study Site
San Antonio
Texas
78215
United States
Regeneron Study Site
San Antonio
Texas
78217
United States
Regeneron Study Site
San Antonio
Texas
78249
United States
Regeneron Study Site
Tyler
Texas
75708
United States
Regeneron Study Site
Falls Church
Virginia
22042
United States
Regeneron Study Site
Everett
Washington
98201
United States
Regeneron Study Site
Seattle
Washington
98109
United States
Regeneron Study Site
Seattle
Washington
98122
United States
Regeneron Study Site
Madison
Wisconsin
53792
United States
Regeneron Study Site
Guadalajara
Jalisco
44280
Mexico
Regeneron Study Site
Guadalajara
Jalisco
44340
Mexico
Regeneron Study Site
Zapopan
Jalisco
45070
Mexico
Regeneron Study Site
Monterrey
Nuevo León
64710
Mexico
Regeneron Study Site
Monterrey
Nuevo León
64718
Mexico
Regeneron Study Site
Mérida
Yucatán
97070
Mexico
Regeneron Study Site
Chihuahua City
31238
Mexico
Regeneron Study Site
Durango
34000
Mexico
Regeneron Study Site
Mexico City
3100
Mexico
Regeneron Study Site
Mérida
97000
Mexico
Regeneron Study Site
Veracruz
91900
Mexico
Regeneron Study Site
Bucharest
021105
Romania
Derived
Rofail D, Hussein M, Naumann U, Podolanczuk AJ, Norton T, Ali S, Mastey V, Ivanescu C, Hirshberg B, Geba GP. Patient-Reported Outcomes in COVID-19 Treatment with Monoclonal Antibodies Reveal Benefits in Return to Usual Activities. Infect Dis Ther. 2024 Aug;13(8):1861-1876. doi: 10.1007/s40121-024-01013-1. Epub 2024 Jul 3.
Murayama A. Industry Payments to Pediatricians in the United States Between 2013 and 2021. Clin Pediatr (Phila). 2024 Oct;63(9):1308-1317. doi: 10.1177/00099228231218850. Epub 2023 Dec 15.
Bermejo-Gomez A, Aguilera-Alonso D, Rincon-Lopez EM, Catalan-Alonso P, Bardon-Cancho EJ, Garcia-Morin M, Manrique-Rodriguez S, Navarro-Gomez ML. Use of Monoclonal Antibodies in a Pediatric Patient With Severe Combined Immunodeficiency and Persistent SARS-CoV-2 Infection. Pediatr Infect Dis J. 2023 Aug 1;42(8):e290-e292. doi: 10.1097/INF.0000000000003938. Epub 2023 Apr 27.
Weinreich DM, Sivapalasingam S, Norton T, Ali S, Gao H, Bhore R, Xiao J, Hooper AT, Hamilton JD, Musser BJ, Rofail D, Hussein M, Im J, Atmodjo DY, Perry C, Pan C, Mahmood A, Hosain R, Davis JD, Turner KC, Baum A, Kyratsous CA, Kim Y, Cook A, Kampman W, Roque-Guerrero L, Acloque G, Aazami H, Cannon K, Simon-Campos JA, Bocchini JA, Kowal B, DiCioccio AT, Soo Y, Geba GP, Stahl N, Lipsich L, Braunstein N, Herman G, Yancopoulos GD; Trial Investigators. REGEN-COV Antibody Combination and Outcomes in Outpatients with Covid-19. N Engl J Med. 2021 Dec 2;385(23):e81. doi: 10.1056/NEJMoa2108163. Epub 2021 Sep 29.
Weinreich DM, Sivapalasingam S, Norton T, Ali S, Gao H, Bhore R, Musser BJ, Soo Y, Rofail D, Im J, Perry C, Pan C, Hosain R, Mahmood A, Davis JD, Turner KC, Hooper AT, Hamilton JD, Baum A, Kyratsous CA, Kim Y, Cook A, Kampman W, Kohli A, Sachdeva Y, Graber X, Kowal B, DiCioccio T, Stahl N, Lipsich L, Braunstein N, Herman G, Yancopoulos GD; Trial Investigators. REGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with Covid-19. N Engl J Med. 2021 Jan 21;384(3):238-251. doi: 10.1056/NEJMoa2035002. Epub 2020 Dec 17.
FG002
Phase 1 Symptomatic: 8.0 IV
8.0g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
FG003
Phase 2 Symptomatic: Placebo
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
FG004
Phase 2 Symptomatic: 2.4 IV
2.4g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
FG005
Phase 2 Symptomatic: 8.0 IV
8.0g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
FG006
Phase 2 Asymptomatic: Placebo
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
FG007
Phase 2 Asymptomatic: 2.4 IV
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
FG008
Phase 2 Asymptomatic: 8.0 IV
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
FG009
Phase 3 Age>=18: Placebo
Placebo of R10933 + R10987 Participants >= 18 with COVID-19, not pregnant at randomization
FG010
Phase 3 Age>=18: 1.2 IV
1.2g of R10933 + R10987 Participants >= 18 with COVID-19, not pregnant at randomization
FG011
Phase 3 Age>=18: 2.4 IV
2.4g of R10933 + R10987 Participants >= 18 with COVID-19, not pregnant at randomization
FG012
Phase 3 Age>=18: 8.0 IV
8.0g of R10933 + R10987 Participants >= 18 with COVID-19, not pregnant at randomization
FG013
Phase 3 Age <18: Placebo
Placebo of R10933 + R10987 Participants <18 with COVID-19, not pregnant at randomization
FG014
Phase 3 Age <18: 1.2 IV
1.2g of R10933 + R10987 Participants <18 with COVID-19
FG015
Phase 3 Age <18: 2.4 IV
2.4g of R10933 + R10987 Participants <18 with COVID-19
FG016
Phase 3 Pregnant Placebo
Placebo of R10933 + R10987 Participants who are pregnant with COVID-19
FG017
Phase 3 Pregnant 1.2 IV
1.2g of R10933 + R10987 Participants who are pregnant with COVID-19
FG018
Phase 3 Pregnant: 2.4 IV
2.4g of R10933 + R10987 Participants who are pregnant with COVID-19
FG00024 subjects
FG00124 subjects
FG00224 subjects
FG003242 subjects
FG004242 subjects
FG005243 subjects
FG00676 subjects
FG00776 subjects
FG00876 subjects
FG0092378 subjects
FG0102156 subjects
FG0113189 subjects
FG0121027 subjects
FG0132 subjects
FG014129 subjects
FG01575 subjects
FG0163 subjects
FG01743 subjects
FG01836 subjects
COMPLETED
FG00023 subjects
FG00119 subjects
FG00222 subjects
FG003230 subjects
FG004232 subjects
FG005233 subjects
FG00671 subjects
FG00773 subjects
FG00874 subjects
FG0092217 subjects
FG0101974 subjects
FG0112947 subjects
FG012962 subjects
FG0132 subjects
FG014123 subjects
FG01565 subjects
FG0162 subjects
FG01740 subjects
FG01833 subjects
NOT COMPLETED
FG0001 subjects
FG0015 subjects
FG0022 subjects
FG00312 subjects
FG00410 subjects
FG00510 subjects
FG0065 subjects
FG0073 subjects
FG0082 subjects
FG009161 subjects
FG010182 subjects
FG011242 subjects
FG01265 subjects
FG0130 subjects
FG0146 subjects
FG01510 subjects
FG0161 subjects
FG0173 subjects
FG0183 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0093 subjects
FG0102 subjects
FG0111 subjects
FG0121 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
Lost to Follow-up
FG0001 subjects
FG0013 subjects
FG0021 subjects
FG0037 subjects
FG004
Subject Decision
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0033 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Sponsor Request
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase 1 Symptomatic: Placebo
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
BG001
Phase 1 Symptomatic: 2.4 IV
2.4g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
BG002
Phase 1 Symptomatic: 8.0 IV
8.0g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
BG003
Phase 2 Symptomatic: Placebo
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
BG004
Phase 2 Symptomatic: 2.4 IV
2.4g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
BG005
Phase 2 Symptomatic: 8.0 IV
8.0g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
BG006
Phase 2 Asymptomatic: Placebo
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
BG007
Phase 2 Asymptomatic: 2.4 IV
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
BG008
Phase 2 Asymptomatic: 8.0 IV
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
BG009
Phase 3 Age>=18: Placebo
Placebo of R10933 + R10987 Participants >=18 with COVID-19, not pregnant at randomization
BG010
Phase 3 Age>=18: 1.2 IV
1.2g of R10933 + R10987 Participants >=18 with COVID-19, not pregnant at randomization
BG011
Phase 3 Age>=18: 2.4 IV
2.4g of R10933 + R10987 Participants >=18 with COVID-19, not pregnant at randomization
BG012
Phase 3 Age>=18: 8.0 IV
8.0g of R10933 + R10987 Participants >=18 with COVID-19, not pregnant at randomization
BG013
Phase 3 Age <18: Placebo
Placebo of R10933 + R10987 Participants <18 with COVID-19, not pregnant at randomization
BG014
Phase 3 Age <18: 1.2 IV
1.2g of R10933 + R10987 Participants <18 with COVID-19
BG015
Phase 3 Age <18: 2.4 IV
2.4g of R10933 + R10987 Participants <18 with COVID-19
BG016
Phase 3 Pregnant Placebo
Placebo of R10933 + R10987 Participants who are pregnant with COVID-19
BG017
Phase 3 Pregnant 1.2 IV
1.2g of R10933 + R10987 Participants who are pregnant with COVID-19
BG018
Phase 3 Pregnant: 2.4 IV
2.4g of R10933 + R10987 Participants who are pregnant with COVID-19
BG019
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00024
BG00124
BG00224
BG003242
BG004242
BG005243
BG00676
BG00776
BG00876
BG0092378
BG0102156
BG0113189
BG0121027
BG0132
BG014129
BG01575
BG0163
BG01743
BG01836
BG01910065
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Median
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00040.5(18 to 72)
BG00139.5(18 to 65)
BG00239.0(20 to 72)
BG003
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<18
BG0000
BG0010
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00010
BG00114
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0001
BG0010
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0008
BG00111
BG002
Race
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG00020
BG00116
BG002
Age Continous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00043.8± 14.42
BG00138.9± 11.11
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
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) - [Ph1, Ph2, Ph3 Cohort 1 - Cohort 3]
Primary:
Phase 1, Phase 3 (Cohort 2 and Cohort 3)
Secondary:
Phase 2, Phase 3 (Cohort 1)
Analysis populations were prespecified in the SAP. Pooled analyses were performed for symptomatic adult participants randomized in Phase 1, 2, or 3 (cohort 1) on or before 2/24/21 to placebo, R10933+R10987 1.2 g, 2.4 g, or 8.0 g IV. No phase 1 or 2 participants were randomized to R10933+R10987 1.2 g IV. Asymptomatic adult participants randomized to the asymptomatic cohort of phase 2, symptomatic pediatric / pregnant participants randomized in phase 3 to cohort 2 or 3 were analyzed separately
Number of Participants With Infusion-related Reactions (Ph1, Ph2, Ph3 Cohort 1 - Cohort 3)
Primary:
Phase 1, Phase 3 (Cohort 2 and Cohort 3)
Secondary:
Phase 2, Phase 3 (Cohort 1)
Analysis populations were prespecified in the SAP. Pooled analyses were performed for symptomatic adult participants randomized in Phase 1, 2, or 3 (cohort 1) on or before 2/24/21 to placebo, R10933+R10987 1.2 g, 2.4 g, or 8.0 g IV. No phase 1 or 2 participants were randomized to R10933+R10987 1.2 g IV. Asymptomatic adult participants randomized to the asymptomatic cohort of phase 2, symptomatic pediatric / pregnant participants randomized in phase 3 to cohort 2 or 3 were analyzed separately.
Pooled analysis of Phases 1, 2, & 3 Cohort 1 Symptomatic Participants for dosage of 8.0g IV
Primary
Number of Participants With Hypersensitivity Reactions (Ph1, Ph2, Ph3 Cohort 1 - Cohort 3)
Primary:
Phase 1, Phase 3 (Cohort 2 and Cohort 3)
Secondary:
Phase 2, Phase 3 (Cohort 1)
Analysis populations were prespecified in the SAP. Pooled analyses were performed for symptomatic adult participants randomized in Phase 1, 2, or 3 (cohort 1) on or before 2/24/21 to placebo, R10933+R10987 1.2 g, 2.4 g, or 8.0 g IV. No phase 1 or 2 participants were randomized to R10933+R10987 1.2 g IV. Asymptomatic adult participants randomized to the asymptomatic cohort of phase 2, symptomatic pediatric / pregnant participants randomized in phase 3 to cohort 2 or 3 were analyzed separately.
8.0g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
Primary
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) From Day 1 to Day 7, as Measured by Quantitative Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) in Nasopharyngeal (NP) Swab Samples (Ph1, Ph2)
Primary:
Phase 1, Phase 2
All randomized participants in Phase 1 or Phase 2 with qualitatively positive RT-qPCR in NP swab samples at randomization or collected within 2 hours after study drug infusion was initiated. This pooled modified full analysis set (mFAS) includes all randomized patients with positive RT-qPCR in NP swab samples at randomization and is based on the treatment allocated (as randomized).
Posted
Mean
Standard Deviation
log10 copies/mL
Baseline up to Day 7
ID
Title
Description
OG000
Phase 1 + Phase 2 Symptomatic (Placebo)
Pooled Phase 1 + Phase 2 Symptomatic Placebo Participants
OG001
Phase 1 + Phase 2 Symptomatic (2.4g IV)
Pooled Phase 1 + Phase 2 Symptomatic 2.4g IV Participants
OG002
Phase 1 + Phase 2 Symptomatic (8.0g IV)
Pooled Phase 1 + Phase 2 Symptomatic 8.0g IV Participants
Primary
Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Ph3 Cohort 1- 1.2g vs Placebo)
Phase 3 Cohort 1
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Number
95% Confidence Interval
Percentage of Participants
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo) >=18
Phase 3 Cohort 1 (Placebo)
OG001
Phase 3 Cohort 1 (1.2g IV) >= 18
Phase 3 Cohort 1 (1.2g IV)
Units
Counts
Participants
OG000
Primary
Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Ph3 Cohort 1 - 2.4g vs Placebo)
Primary:
Phase 3 (Cohort 1)
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Number
95% Confidence Interval
Percentage of Participants
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo) >=18
Phase 3 Cohort 1 (Placebo)
OG001
Phase 3 Cohort 1 (2.4g IV) >= 18
Phase 3 Cohort 1 (2.4g IV)
Units
Counts
Participants
OG000
Primary
Concentration of REGN10983 + REGN10987 in Serum Over Time (Ph3 Cohort 2)
Phase 3 Cohort 2
[Nominal Sampling Time] = [Clinical Study Time (Visit Day - 1)]
The pharmacokinetics (PK) analysis population includes all patients who received any study drug (safety population) and who had at least 1 non-missing result following the first dose of study drug
Posted
Mean
Standard Deviation
mg/L
Up to Nominal Sampling Day 28
ID
Title
Description
OG000
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
OG001
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
Units
Counts
Participants
OG000
Secondary
Time to COVID-19 Symptoms Resolution (Ph3 Cohort 1 - 1.2g vs Placebo)
Phase 3 Cohort 1
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Median
95% Confidence Interval
Days
Up to Day 29
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo)
Phase 3 Cohort 1 (Placebo)
OG001
Phase 3 Cohort 1 (1.2 g IV)
Phase 3 Cohort 1 (1.2 g IV) - Post PA6 mFAS
Units
Counts
Participants
OG000
Secondary
Time to COVID-19 Symptoms Resolution (Ph3 Cohort 1 - 2.4g vs Placebo)
Phase 3 (Cohort 1)
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Median
95% Confidence Interval
Days
Through Day 29
ID
Title
Description
OG000
Phase 3 Age>=18: Placebo
Placebo of R10933 + R10987 Participants >= 18 with COVID-19, not pregnant at randomization
OG001
Phase 3 Age>=18: 2.4 IV
2.4g of R10933 + R10987 Participants >= 18 with COVID-19, not pregnant at randomization
Units
Counts
Participants
OG000
Secondary
Proportion of Participants With ≥1 COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1 - 1.2g vs. Placebo)
Phase 3 (Cohort 1)
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Number
Participants
Day 4 thru Day 29
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo) >=18
Phase 3 Cohort 1 (Placebo)
OG001
Phase 3 Cohort 1 (1.2g IV) >= 18
Phase 3 Cohort 1 (1.2g IV)
Units
Counts
Participants
OG000
Secondary
Proportion of Participants With ≥1 COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1 - 2.4g vs. Placebo)
Phase 3 (Cohort 1)
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Number
Participants
From Day 4 Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo) >=18
Phase 3 Cohort 1 (Placebo)
OG001
Phase 3 Cohort 1 (2.4g IV) >= 18
Phase 3 Cohort 1 (2.4g IV)
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs (Next Phase 2 Cohort)
Next Phase 2 Symptomatic
Participants analyzed are part of modified Full Analysis Set (mFAS) and have documented status at baseline. Next Phase 2 participants included the next 524 participants randomized to Phase 2 subsequent to the first 275 symptomatic participants randomized in Phase 1 / 2
Posted
Least Squares Mean
Standard Error
log10 copies/mL
Day 5, Day 7, Day 15, Day 29
ID
Title
Description
OG000
Next Phase 2 (Placebo)
Next Phase 2 Placebo Participants
OG001
Next Phase 2 (2.4g IV)
Next Phase 2 Participants 2.4g IV
OG002
Next Phase 2 (8.0g IV)
Next Phase 2 Participants 8.0g IV
Units
Counts
Participants
Secondary
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) From Day 1 to Post-baseline Study Days (Ph1, Ph2)
Phase 1, Phase 2
All randomized participants pooled in Phase 1 or Phase 2 with qualitatively positive RT-qPCR in NP swab samples at randomization or collected within 2 hours after study drug infusion was initiated. This modified full analysis set (mFAS) includes all randomized patients with positive RT-qPCR in NP swab samples at randomization and is based on the treatment allocated (as randomized).
Posted
Least Squares Mean
Standard Error
log10 copies/mL
Day 1 to Day 29
ID
Title
Description
OG000
Phase 1 + Phase 2 Symptomatic (Placebo)
Pooled Phase 1 + Phase 2 Symptomatic Placebo Participants
OG001
Phase 1 + Phase 2 Symptomatic (2.4g IV)
Pooled Phase 1 + Phase 2 Symptomatic 2.4g IV Participants
OG002
Phase 1 + Phase 2 Symptomatic (8.0g IV)
Pooled Phase 1 + Phase 2 Symptomatic 8.0g IV Participants
Secondary
Percentage of Participants With ≥1 COVID-19-related Medically-attended Visit Through Day 29 (Ph1, Ph2)
Phase 1, Phase 2
All randomized participants pooled in Phase 1 or Phase 2 with qualitatively positive RT-qPCR in NP swab samples at randomization or collected within 2 hours after study drug infusion was initiated. This modified full analysis set (mFAS) includes all randomized patients with positive RT-qPCR in NP swab samples at randomization and is based on the treatment allocated (as randomized).
Posted
Number
95% Confidence Interval
Percentage of Participants
Through Day 29
ID
Title
Description
OG000
Phase 1 + Phase 2 Symptomatic (Placebo)
Pooled Phase 1 + Phase 2 Symptomatic Placebo Participants
OG001
Phase 1 + Phase 2 Symptomatic (2.4g IV)
Pooled Phase 1 + Phase 2 Symptomatic 2.4g IV Participants
OG002
Phase 1 + Phase 2 Symptomatic (8.0g IV)
Pooled Phase 1 + Phase 2 Symptomatic 8.0g IV Participants
Units
Secondary
Percentage of Participants With ≥1 COVID-19 Related Hospitalization, Emergency Room, or Urgent Care Visit Through Day 29 (Ph1, Ph2)
Phase 1, Phase 2
All randomized participants pooled in Phase 1 or Phase 2 with qualitatively positive RT-qPCR in NP swab samples at randomization or collected within 2 hours after study drug infusion was initiated. This modified full analysis set (mFAS) includes all randomized patients with positive RT-qPCR in NP swab samples at randomization and is based on the treatment allocated (as randomized).
Posted
Number
95% Confidence Interval
Percentage of Participants
Through Day 29
ID
Title
Description
OG000
Phase 1 + Phase 2 Symptomatic (Placebo)
Pooled Phase 1 + Phase 2 Symptomatic Placebo Participants
OG001
Phase 1 + Phase 2 Symptomatic (2.4g IV)
Pooled Phase 1 + Phase 2 Symptomatic 2.4g IV Participants
OG002
Phase 1 + Phase 2 Symptomatic (8.0g IV)
Pooled Phase 1 + Phase 2 Symptomatic 8.0g IV Participants
Secondary
Time to First Onset of Symptoms Consistent With COVID-19 (Phase 2 Asymptomatic Cohort Only)
Phase 2 Only
Phase 2 asymptomatic cohort
Posted
Median
95% Confidence Interval
Days
Up to Day 29
ID
Title
Description
OG000
Placebo
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
OG001
Phase 2 Asymptomatic: 2.4 IV
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
OG002
Phase 2 Asymptomatic: 8.0 IV
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
Units
Counts
Participants
OG000
Secondary
Proportion of Participants With ≥1 COVID-19-related Hospitalization, Emergency Room Visit, or All-cause Death (Ph3 Cohort 1) - Placebo vs. 1.2g IV
Phase 3 Cohort 1 - Placebo vs. 1.2 g IV
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Number
Participants
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo) >=18
Phase 3 Cohort 1 (Placebo)
OG001
Phase 3 Cohort 1 (1.2g IV) >= 18
Phase 3 Cohort 1 (1.2g IV)
Units
Counts
Participants
OG000
Secondary
Proportion of Participants With ≥1 COVID-19-related Hospitalization, Emergency Room Visit, or All-cause Death (Ph3 Cohort 1) - Placebo vs. 2.4g IV
Phase 3 (Cohort 1)
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Number
Participants
Through day 29
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo) >=18
Phase 3 Cohort 1 (Placebo)
OG001
Phase 3 Cohort 1 (2.4g IV) >= 18
Phase 3 Cohort 1 (2.4g IV)
Units
Counts
Participants
OG000
Secondary
Concentration of REGN10933 + REGN10987 in Serum Over Time (Ph1 Cohort 1, Ph2 Cohort 1, Ph3 Cohort 1 and Cohort 3)
[Nominal Sampling Time] = [Clinical Study Time (Visit Day - 1)]
The pharmacokinetics (PK) analysis population includes all patients who received any study drug (safety population) and who had at least 1 non-missing result following the first dose of study drug
Posted
Mean
Standard Deviation
mg/L
Up to Nominal Sampling Day 28
ID
Title
Description
OG000
Phase 1 (2.4g IV)
Phase 1 (2.4g IV) - PK Analysis Set
OG001
Phase 1 (8.0g IV)
Phase 1 (8.0g IV) - PK Analysis Set
OG002
Phase 2 (2.4g IV)
Phase 2 (2.4g IV) - PK Analysis Set
OG003
Phase 2 (8.0g IV)
Phase 2 (8.0g IV) - PK Analysis Set
OG004
Secondary
Assessment of Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of REGN10933+REGN10987 (Phase 1)
Phase 1 Only
The pharmacokinetics (PK) analysis population includes all patients who received any study drug (safety population) and who had at least 1 non-missing result following the first dose of study drug
Posted
Mean
Standard Deviation
mg/L
Through Day 29
ID
Title
Description
OG000
Phase 1 PK-AS
Phase 1 PK-AS (Pharmacokinetic Analysis Set)
Units
Counts
Participants
OG00045
Secondary
Assessment of PK Parameter: Time to Cmax (Tmax) for REGN10933+REGN10987 (Phase 1)
Phase 1 Only
The pharmacokinetics (PK) analysis population includes all patients who received any study drug (safety population) and who had at least 1 non-missing result following the first dose of study drug
Posted
Median
Full Range
Days
Through Day 29
ID
Title
Description
OG000
Phase 1 PK-AS
Phase 1 PK-AS (Pharmacokinetic Analysis Set)
Units
Counts
Participants
OG00045
Secondary
Assessment of PK Parameter: Area Under the Curve (AUC) Computed From Time Zero to Day 28 Concentration (AUC 0-28) for REGN10933+REGN10987 (Phase 1)
Phase 1 Only
The pharmacokinetics (PK) analysis population includes all patients who received any study drug (safety population) and who had at least 1 non-missing result following the first dose of study drug
Posted
Mean
Standard Deviation
day*milligram/Liter
Through Day 29
ID
Title
Description
OG000
Phase 1 PK-AS
Phase 1 PK-AS (Pharmacokinetic Analysis Set)
Units
Counts
Participants
OG00045
Secondary
Immunogenicity as Measured by Anti-drug (ADA) to REGN10933 (Ph1 Cohort 1, Ph2 Cohort 1, Ph3 Cohort 1)
The anti-drug antibody (ADA) analysis set (AAS) includes all subjects who received any study drug (safety population) and had at least one non-missing ADA result from the ADA assay after first dose of the study drug(s). Pooled participants will be analyzed according to the treatment actually received. This is an adaptive master protocol design, to allow for flexible adaptation for participants with symptomatic COVID-19, as well as with those with asymptomatic SARS-CoV-2.
Posted
Number
Participants
Through Day 29
ID
Title
Description
OG000
Phases 1,2, & 3 Cohort 1 Symptomatic (Placebo)
Pooled analysis of Phases 1, 2, & 3 Cohort 1 Symptomatic Participants for Placebo
OG001
Phases 3 Cohort 1 Symptomatic (1.2g IV)
Phase 3 Cohort 1 Symptomatic Participants for dosage of 1.2g IV
OG002
Phases 1, 2, & 3 Cohort 1 Symptomatic (2.4g IV)
Pooled analysis of Phases 1, 2, & 3 Cohort 1 Symptomatic Participants for dosage of 2.4g IV
Secondary
Immunogenicity as Measured by Anti-drug (ADA) to REGN10933 (Ph3 Cohort 2 - Cohort 3)
The anti-drug antibody (ADA) analysis set (AAS) includes all subjects who received any study drug (safety population) and had at least one non-missing ADA result from the ADA assay after first dose of the study drug(s). Participants will be analyzed according to the treatment actually received. This is an adaptive master protocol design, to allow for flexible adaptation for participants with symptomatic COVID-19, as well as with those with asymptomatic SARS-CoV-2.
Posted
Number
Participants
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 2 (Placebo)
Phase 3 Cohort 2 (Placebo) - ADA Analysis Set
OG001
Phase 3 Cohort 2 (1.2g IV)
Phase 3 Cohort 2 (1.2g IV) - ADA Analysis Set
OG002
Phase 3 Cohort 2 (2.4g IV)
Phase 3 Cohort 2 (2.4g IV) - ADA Analysis Set
OG003
Phase 3 Cohort 3 (Placebo)
Secondary
Immunogenicity as Measured by ADA to REGN10987 (Ph1 Cohort 1, Ph2 Cohort 1, Ph3 Cohort 1)
The anti-drug antibody (ADA) analysis set (AAS) includes all subjects who received any study drug (safety population) and had at least one non-missing ADA result from the ADA assay after first dose of the study drug(s). Pooled participants will be analyzed according to the treatment actually received. This is an adaptive master protocol design, to allow for flexible adaptation for participants with symptomatic COVID-19, as well as with those with asymptomatic SARS-CoV-2.
Posted
Number
Participants
Through Day 29
ID
Title
Description
OG000
Pooled Phases 1,2, & 3 Cohort 1 Symptomatic (Placebo)
Pooled analysis of Phases 1, 2, & 3 Cohort 1 Symptomatic Participants for Placebo
OG001
Phase 3 Cohort 1 Symptomatic (1.2g IV)
Phases 3 Cohort 1 Symptomatic Participants for dosage of 1.2g IV
The anti-drug antibody (ADA) analysis set (AAS) includes all subjects who received any study drug (safety population) and had at least one non-missing ADA result from the ADA assay after first dose of the study drug(s). Participants will be analyzed according to the treatment actually received. This is an adaptive master protocol design, to allow for flexible adaptation for participants with symptomatic COVID-19, as well as with those with asymptomatic SARS-CoV-2.
Posted
Number
Participants
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 2 (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
OG001
Phase 3 Cohort 2 (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
OG002
Phase 3 Cohort 2 (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
OG003
Phase 3 Cohort 3 (Placebo)
Secondary
Immunogenicity as Measured by Neutralizing Antibodies (NAbs) to REGN10933 (Ph3 Cohort 2, Ph3 Cohort 3)
(TE&TB+;NAb+) = TE = Treatment-emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay
The anti-drug antibody (ADA) analysis set (AAS) includes all subjects who received any study drug (safety population) and had at least one non-missing ADA result from the ADA assay after first dose of the study drug(s). Participants will be analyzed according to the treatment actually received. This is an adaptive master protocol design, to allow for flexible adaptation for participants with symptomatic COVID-19, as well as with those with asymptomatic SARS-CoV-2.
Posted
Number
Participants
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 2 (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
OG001
Phase 3 Cohort 2 (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
OG002
Phase 3 Cohort 2 (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
OG003
Phase 3 Cohort 3 (Placebo)
Secondary
Immunogenicity as Measured by NAbs to REGN10987 (Ph3 Cohort 2 - Cohort 3)
(TE&TB+;NAb+) = TE = Treatment-emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay
The anti-drug antibody (ADA) analysis set (AAS) includes all subjects who received any study drug (safety population) and had at least one non-missing ADA result from the ADA assay after first dose of the study drug(s). Participants will be analyzed according to the treatment actually received.
Posted
Number
Participants
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 2 (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
OG001
Phase 3 Cohort 2 (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
OG002
Phase 3 Cohort 2 (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
OG003
Phase 3 Cohort 3 (Placebo)
Phase 3 Cohort 3 Pregnant (Placebo)
Secondary
Number of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death (Phase 3 Cohort 2)
Phase 3 (Cohort 2)
Participants <18 years old who, at baseline, were not pregnant, had symptomatic COVID-19, and had at least 1 risk factor for developing severe disease
Posted
Count of Participants
Participants
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
OG001
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
OG002
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
Units
Counts
Participants
OG000
Secondary
Percentage of Participants With ≥1 COVID-19-related Medically-attended Visit (Phase 1, Phase 2)
Phase 1, Phase 2 Medically-attended Visits include Hospitalizations, ER visits, Urgent Care Clinic visits, Outpatient/physician office/telemedicine visits
All randomized participants in Phase 1 or Phase 2 with qualitatively positive RT-qPCR in NP swab samples at randomization or collected within 2 hours after study drug infusion was initiated. This modified full analysis set (mFAS) includes all randomized patients with positive RT-qPCR in NP swab samples at randomization and is based on the treatment allocated (as randomized).
Posted
Number
95% Confidence Interval
Percentage of Participants
Through Day 29
ID
Title
Description
OG000
Phase 1 + Phase 2 Symptomatic (Placebo)
Pooled Phase 1 + Phase 2 Symptomatic Placebo Participants
OG001
Phase 1 + Phase 2 Symptomatic (2.4g IV)
Pooled Phase 1 + Phase 2 Symptomatic 2.4g IV Participants
OG002
Phase 1 + Phase 2 Symptomatic (8.0g IV)
Pooled Phase 1 + Phase 2 Symptomatic 8.0g IV Participants
Secondary
Percentage of Participants With ≥2 COVID-19-related Medically-attended Visit - (Ph3 Cohort 1) - Placebo vs. 1.2g IV
Phase 3 (Cohort 1)
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Number
95% Confidence Interval
Percentage of Participants
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo)
Phase 3 Cohort 1 (Placebo) Participants
OG001
Phase 3 Cohort 1 (1.2g IV) >=18
Phase 3 Cohort 1 (1.2g IV) Participants
Units
Counts
Participants
OG000
Secondary
Percentage of Participants With ≥2 COVID-19-related Medically-attended Visit - (Ph3 Cohort 1) - Placebo vs. 2.4g IV
Phase 3 Cohort 1
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Number
95% Confidence Interval
Percentage of Participants
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo)
Phase 3 Cohort 1 (Placebo) Participants
OG001
Phase 3 Cohort 1 (2.4g IV) >=18
Phase 3 Cohort 1 (2.4g IV) Participants
Units
Counts
Participants
OG000
Secondary
Total Number of COVID-19-related Medically-attended Visits (Phase 1 and Phase 2)
Phase 1 and Phase 2
Analysis populations were prespecified in the SAP. Pooled analyses were performed for symptomatic adult participants randomized in Phase 1, 2, or 3 (cohort 1) on or before 2/24/21 to placebo, R10933+R10987 1.2 g, 2.4 g, or 8.0 g IV. No phase 1 or 2 participants were randomized to R10933+R10987 1.2 g IV. Asymptomatic adult participants randomized to the asymptomatic cohort of phase 2, symptomatic pediatric / pregnant participants randomized in phase 3 to cohort 2 or 3 were analyzed separately.
Posted
Number
Number of Participants
Through Day 29
ID
Title
Description
OG000
Phase 1 + Phase 2 Symptomatic
Pooled Phase 1 + Phase 2 Symptomatic Participants mFAS (modified Full Analysis Set)
OG001
Phase 1 + Phase 2 Symptomatic 2.4g IV
Pooled Phase 1 + Phase 2 Symptomatic 2.4g IV mFAS (modified Full Analysis Set)
OG002
Phase 1 + Phase 2 Symptomatic 8.0g IV mFAS (Modified Full Analysis Set)
Pooled Phase 1 + Phase 2 Symptomatic 8.0g IV mFAS (modified Full Analysis Set)
Secondary
Assessment of Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of REGN10933 and REGN10987 (Phase 1 Only)
Phase 1 Only
The pharmacokinetics (PK) analysis pooled population includes all patients who received any study drug (safety population) and who had at least 1 non-missing result following the first dose of study drug
PK-AS of participants in Phase 1 Adult Symptomatic Participants with COVID-19
Units
Counts
Participants
OG000
Secondary
Assessment of PK Parameter: Cmax-to-dose Ratio (Cmax/Dose) of REGN10933 and REGN10987 (Phase 1 Only)
Phase 1 Only
The pharmacokinetics (PK) analysis population includes all patients who received any study drug (safety population) and who had at least 1 non-missing result following the first dose of study drug
PK-AS of participants in Phase 1 Adult Symptomatic Participants with COVID-19
Units
Counts
Participants
OG000
Secondary
Assessment of PK Parameter: Time to Cmax (Tmax) for REGN10933 and REGN10987 (Phase 1 Only)
Phase 1 Only
The pharmacokinetics (PK) analysis population includes all patients who received any study drug (safety population) and who had at least 1 non-missing result following the first dose of study drug
PK-AS of participants in Phase 1 Adult Symptomatic Participants with COVID-19
Units
Counts
Participants
OG00045
Secondary
Assessment of PK Parameter: Area Under the Curve (AUC) Computed From Time Zero to the Time of the Last Positive Concentration (AUClast) for REGN10933 - (Phase 1 Only)
Phase 1 Only - Tlast (Time of last quantifiable concentration)
The pharmacokinetics (PK) analysis population includes all patients who received any study drug (safety population) and who had at least 1 non-missing result following the first dose of study drug
Posted
Median
Full Range
((day*mg/L)/mg)
Through Day 29
ID
Title
Description
OG000
Phase 1 PK-AS (Pharmacokinetic Analysis Set)
PK-AS of participants in Phase 1 Adult Symptomatic Participants with COVID-19
Units
Counts
Participants
OG000
Secondary
Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Phase 3 Cohort 1
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 4 Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo) >=18
Phase 3 Cohort 1 (Placebo)
OG001
Phase 3 Cohort 1 (1.2g IV) >= 18
Phase 3 Cohort 1 (1.2g IV)
Units
Counts
Participants
OG000
Secondary
Proportion of Participants With at Least One (≥1) COVID-19-related Hospitalization or All-cause Death From Day 4 Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Phase 3 Cohort 1
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 4 Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo) >=18
Phase 3 Cohort 1 (Placebo)
OG001
Phase 3 Cohort 1 (2.4g IV) >= 18
Phase 3 Cohort 1 (2.4g IV)
Units
Counts
Participants
OG000
Secondary
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Phase 3 Cohort 1
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Number
95% Confidence Interval
Percentage of Participants
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo) >=18
Phase 3 Cohort 1 (Placebo)
OG001
Phase 3 Cohort 1 (1.2g IV) >= 18
Phase 3 Cohort 1 (1.2g IV)
Units
Counts
Participants
OG000
Secondary
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Phase 3 Cohort 1
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Number
95% Confidence Interval
Percentage of Participants
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo) >=18
Phase 3 Cohort 1 (Placebo)
OG001
Phase 3 Cohort 1 (2.4g IV) >= 18
Phase 3 Cohort 1 (2.4g IV)
Units
Counts
Participants
OG000
Secondary
Number of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Phase 3 Cohort 2)
Phase 3 (Cohort 2)
Participants <18 years old who, at baseline, were not pregnant, had symptomatic COVID-19, and had at least 1 risk factor for developing severe disease
Posted
Count of Participants
Participants
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
OG001
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
OG002
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
Units
Counts
Participants
Secondary
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit by Type of Visit Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Phase 3 Cohort 1
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Number
95% Confidence Interval
Percentage of Participants
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo) >=18
Phase 3 Cohort 1 (Placebo)
OG001
Phase 3 Cohort 1 (1.2g IV) >= 18
Phase 3 Cohort 1 (1.2g IV)
Units
Counts
Participants
OG000
Secondary
Proportion of Participants With at Least One (≥1) COVID-19-related Medically-attended Visit by Type of Visit Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Phase 3 Cohort 1
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Number
95% Confidence Interval
Percentage of Participants
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo) >=18
Phase 3 Cohort 1 (Placebo)
OG001
Phase 3 Cohort 1 (2.4g IV) >= 18
Phase 3 Cohort 1 (2.4g IV)
Units
Counts
Participants
OG000
Secondary
Total Number of COVID-19-related Medically-attended Visits by Type of Visit Through Day 29 (Phase 3 Cohort 2)
Phase 3 (Cohort 2)
Participants <18 years old who, at baseline, were not pregnant, had symptomatic COVID-19, and had at least 1 risk factor for developing severe disease
Posted
Number
Medically-Attended Visit
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
OG001
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
OG002
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
Units
Counts
Participants
OG000
Secondary
Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Phase 3 Cohort 1
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Number
95% Confidence Interval
Cumulative Incidence Percentage
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo) >=18
Phase 3 Cohort 1 (Placebo)
OG001
Phase 3 Cohort 1 (1.2g IV) >= 18
Phase 3 Cohort 1 (1.2g IV)
Units
Counts
Participants
OG000
Secondary
Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Phase 3 Cohort 1
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Number
95% Confidence Interval
Cumulative Incidence Percentage
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo) >=18
Phase 3 Cohort 1 (Placebo)
OG001
Phase 3 Cohort 1 (2.4g IV) >= 18
Phase 3 Cohort 1 (2.4g IV)
Units
Counts
Participants
OG000
Secondary
Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization, Emergency Room (ER) or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Phase 3 Cohort 1
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Number
95% Confidence Interval
Cumulative Incidence Percentage
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo) >=18
Phase 3 Cohort 1 (Placebo)
OG001
Phase 3 Cohort 1 (1.2g IV) >= 18
Phase 3 Cohort 1 (1.2g IV)
Units
Counts
Participants
OG000
Secondary
Cumulative Incidence Percentage of Patients With COVID-19-related Hospitalization, Emergency Room (ER) or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Phase 3 Cohort 1
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Number
95% Confidence Interval
Cumulative Incidence Percentage
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo) >=18
Phase 3 Cohort 1 (Placebo)
OG001
Phase 3 Cohort 1 (2.4g IV) >= 18
Phase 3 Cohort 1 (2.4g IV)
Units
Counts
Participants
OG000
Secondary
Cumulative Incidence Percentage of Patients With COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Phase 3 Cohort 1
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Number
95% Confidence Interval
Cumulative Incidence Percentage
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo) >=18
Phase 3 Cohort 1 (Placebo)
OG001
Phase 3 Cohort 1 (1.2g IV) >= 18
Phase 3 Cohort 1 (1.2g IV)
Units
Counts
Participants
OG000
Secondary
Cumulative Incidence Percentage of Patients With COVID-19-related Medically-attended Visit or All-cause Death Through Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Phase 3 Cohort 1
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Number
95% Confidence Interval
Cumulative Incidence Percentage
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo) >=18
Phase 3 Cohort 1 (Placebo)
OG001
Phase 3 Cohort 1 (2.4g IV) >= 18
Phase 3 Cohort 1 (2.4g IV)
Units
Counts
Participants
OG000
Secondary
Proportion of Participants Requiring Supplemental Oxygen Due to COVID-19 by Day 29 (Ph3 Cohort 1- 1.2g vs Placebo)
Phase 3 Cohort 1
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Number
95% Confidence Interval
Percentage of Participants
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo) >=18
Phase 3 Cohort 1 (Placebo)
OG001
Phase 3 Cohort 1 (1.2g IV) >= 18
Phase 3 Cohort 1 (1.2g IV)
Units
Counts
Participants
OG000
Secondary
Proportion of Participants Requiring Supplemental Oxygen Due to COVID-19 by Day 29 (Ph3 Cohort 1- 2.4g vs Placebo)
Phase 3 Cohort 1
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Number
95% Confidence Interval
Percentage of Participants
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo) >=18
Phase 3 Cohort 1 (Placebo)
OG001
Phase 3 Cohort 1 (2.4g IV) >= 18
Phase 3 Cohort 1 (2.4g IV)
Units
Counts
Participants
OG000
Secondary
Percentage of Participants With All-Cause Death (Ph3 Cohort 1) Placebo vs. 1.2g
Phase 3 Cohort 1
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Number
95% Confidence Interval
Percentage of Participants
by Day 29, Day 120, and Day 169
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo) >=18
Phase 3 Cohort 1 (Placebo)
OG001
Phase 3 Cohort 1 (1.2g IV) >= 18
Phase 3 Cohort 1 (1.2g IV)
Units
Counts
Participants
OG000
Secondary
Percentage of Participants With All-Cause Death (Ph3 Cohort 1) Placebo vs. 2.4g
Phase 3 Cohort 1 Placebo vs. 2.4g IV
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Number
95% Confidence Interval
Percentage of Participants
by Day 29, Day 120, and Day 169
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo) >=18
Phase 3 Cohort 1 (Placebo)
OG001
Phase 3 Cohort 1 (2.4g IV) >= 18
Phase 3 Cohort 1 (2.4g IV)
Units
Counts
Participants
OG000
Secondary
Proportion of Participants With High Viral Load at Each Visit - (Phase 2 Only)
Next Phase 2 Only
In light of evolving information concerning SARS-CoV-2 infection, including the profile of viral load among patients and the adequacy of sampling methodologies, virologic efficacy endpoints and sampling methods were modified during the course of the study.
Posted
Number
95% Confidence Interval
Percentage of Participants
Through Day 29
ID
Title
Description
OG000
Placebo
Placebo Phase 2 Participants
OG001
R10933+R10987 2.4 g IV
R10933+R10987 2.4 g IV
OG002
R10933+R10987 8.0 g IV
R10933+R10987 8.0 g IV
Units
Counts
Participants
OG000
Secondary
Correlation of RT-qPCR Results Over Time Between Different Sample Types (NP, Nasal, and Saliva) - (Phase 1 Only)
Phase 1 Only
Nasal and saliva sample collection was discontinued early in the study because nasopharyngeal samples were determined to be more reliable for quantitative analysis. Therefore, data was not collected for this outcome measure. The Phase 1/2 SAP does not specify any analyses related to nasal and saliva samples collections
Posted
Up to Day 29
ID
Title
Description
OG000
Phase 1 Only
Phase 1 Only Participants
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasal Swabs - (Phase 1 Only)
Phase 1 Only
Nasal and saliva sample collection was discontinued early in the study because nasopharyngeal samples were determined to be more reliable for quantitative analysis. Therefore, data was not collected for this outcome measure. The Phase 1/2 SAP does not specify any analyses related to nasal and saliva samples collections
Posted
Baseline Up To Day 29
ID
Title
Description
OG000
Phase 1 Only
Phase 1 Participants
Units
Counts
Participants
OG0000
Secondary
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Saliva Samples - (Phase 1 Only)
Phase 1 Only
Nasal and saliva sample collection was discontinued early in the study because nasopharyngeal samples were determined to be more reliable for quantitative analysis. Therefore, data was not collected for this outcome measure. The Phase 1/2 SAP does not specify any analyses related to nasal and saliva samples collections
Posted
Baseline Up to Day 29
ID
Title
Description
OG000
Phase 1
Adult Symptomatic Participants with COVID-19
Units
Counts
Participants
OG000
Secondary
Concordance of RT-qPCR Results Over Time Between Different Sample Types (NP, Nasal, and Saliva) - (Phase 1 Only)
Phase 1 Only
Nasal and saliva sample collection was discontinued early in the study because nasopharyngeal samples were determined to be more reliable for quantitative analysis. Therefore, data was not collected for this outcome measure. The Phase 1/2 SAP does not specify any analyses related to nasal and saliva samples collections
Posted
Up To Day 29
ID
Title
Description
OG000
Phase 1 Only
Phase 1 Participants Only
Units
Counts
Participants
OG000
Secondary
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL), as Measured by RT-qPCR in Saliva Samples - (Phase 1)
Phase 1 Only
In light of evolving information concerning SARS-CoV-2 infection, including the profile of viral load among patients and the adequacy of sampling methodologies, virologic efficacy endpoints and sampling methods were modified during the course of the study
Posted
Baseline up to Day 22
ID
Title
Description
OG000
Phase 1
Phase 1 Participants
Units
Counts
Participants
OG0000
Secondary
Number of Participants With Viral Loads Below the Limit of Detection at Each Visit - (Phase 2 Only)
Phase 2 Only
In light of evolving information concerning SARS-CoV-2 infection, including the profile of viral load among patients and the adequacy of sampling methodologies, virologic efficacy endpoints and sampling methods were modified during the course of the study
Posted
Number
Number of Participants
Through Day 29
ID
Title
Description
OG000
Phase 2 Only (Placebo)
Phase 2 (Placebo) Asymptomatic Participants
OG001
Phase 2 (2.4g IV) Participants
Phase 2 (2.4 g IV) Asymptomatic Participants of modified Full Analysis Set (mFAS)
OG002
Phase 2 (8.0g IV) Participants
Phase 2 (8.0g IV) Asymptomatic Participants of modified Full Analysis Set (mFAS)
Units
Counts
Participants
Secondary
Duration of Symptoms Consistent With COVID-19 (Phase 2 Only)
Phase 2 Only
Participants who were part of Phase 2 Asymptomatic modified Full Analysis Set (mFAS)
Posted
Mean
Standard Deviation
Days
Through Day 29
ID
Title
Description
OG000
Phase 2 Placebo
Phase 2 (Placebo) Asymptomatic Participants
OG001
Phase 2 (2.4 g IV) Participants
Phase 2 (2.4 g IV) Asymptomatic Participants of modified Full Analysis Set (mFAS)
OG002
Phase 2 (8.0g IV) Participants
Phase 2 (8.0g IV) Asymptomatic Participants of modified Full Analysis Set (mFAS)
Units
Counts
Participants
OG000
Secondary
Time to First Onset of Symptoms Consistent With COVID-19 (Phase 2 Asymptomatic Cohort Only)
Phase 2 Only
Phase 2 asymptomatic cohort
Posted
Median
Full Range
Days
Through Day 29
ID
Title
Description
OG000
Phase 2 Only
Phase 2 Participants
OG001
Phase 2 2.4g IV
Phase 2 asymptomatic participants
OG002
Phase 2 8.0g IV
Phase 2 asymptomatic participants 8.0g IV
Units
Counts
Participants
OG000
Secondary
Number of Participants Admitted to a Hospital Due to COVID-19 (Phase 1, Phase 2)
Phase 1, Phase 2
All pooled randomized participants in Phase 1 or Phase 2 with qualitatively positive RT-qPCR in NP swab samples at randomization or collected within 2 hours after study drug infusion was initiated. This modified full analysis set (mFAS) includes all randomized patients with positive RT-qPCR in NP swab samples at randomization and is based on the treatment allocated (as randomized).
Pooled Phase 1 + Phase 2 Symptomatic (8.0g IV) Participants
Units
Secondary
Time to Negative RT-qPCR in All Tested Samples With no Subsequent Positive RT-qPCR in Any Tested Samples - (Phase 1 Only)
Phase 1 Only
In light of evolving information concerning SARS-CoV-2 infection, including the profile of viral load among patients and the adequacy of sampling methodologies, virologic efficacy endpoints and sampling methods were modified during the course of the study
Posted
Through Day 29
ID
Title
Description
OG000
Phase 1 Only
Phase 1 Participants
Units
Counts
Participants
OG0000
Secondary
Proportion of Participants With All-cause Mortality (Phase 2 Asymptomatic)
Phase 2 Asymptomatic
Phase 2 asymptomatic cohort
Posted
Number
Participants
Through Day 29
ID
Title
Description
OG000
Phase 2 Asymptomatic Placebo
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
OG001
Phase 2 Asymptomatic R10933+R10987 2.4g IV
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
OG002
Phase 2 Asymptomatic R10933+R10987 8.0g IV
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
Units
Counts
Participants
OG000
Secondary
Time to All-cause Death (Ph3 Cohort 1- 1.2g vs Placebo)
Phase 3 Cohort 1 (1.2g IV)
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Median
95% Confidence Interval
Days
Through Day 169
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo) >= 18
Phase 3 Cohort 1 Participants (Placebo)
OG001
Phase 3 Cohort 1 (1.2g IV) >= 18
Phase 3 Cohort 1 Participants (1.2g IV)
Units
Counts
Participants
OG000
Secondary
Time to All-cause Death (Ph3 Cohort 1- 2.4g vs Placebo)
Phase 3 Cohort 1 (2.4g IV)
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Median
95% Confidence Interval
Days
Through Day 169
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo) >= 18
Phase 3 Cohort 1 Participants (Placebo)
OG001
Phase 3 Cohort 1 (2.4g IV) >= 18
Phase 3 Cohort 1 Participants (2.4g IV)
Units
Counts
Participants
OG000
Secondary
Time to All-cause Death (Phase 3 Cohort 2)
Phase 3 (Cohort 2)
There were no deaths in this cohort. Phase 3 Cohort 2 data was not analyzed for this endpoint as there were no deaths.
Posted
Number
Days
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
OG001
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
OG002
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
Units
Counts
Participants
OG000
Secondary
Proportion of Participants Requiring Mechanical Ventilation Due to COVID-19 (Ph3 Cohort 1- 1.2g vs Placebo)
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Number
95% Confidence Interval
Percentage of Participants
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo) >= 18
Phase 3 Cohort 1 Participants (Placebo)
OG001
Phase 3 Cohort 1 (1.2g IV) >= 18
Phase 3 Cohort 1 Participants (1.2g IV)
Units
Counts
Participants
OG000
Secondary
Proportion of Participants Requiring Mechanical Ventilation Due to COVID-19 (Ph3 Cohort 1- 2.4g vs Placebo)
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Number
95% Confidence Interval
Proportion of Participants
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo)
Phase 3 Cohort 1 Participants (Placebo)
OG001
Phase 3 Cohort 1 (2.4g IV) >= 18
Phase 3 Cohort 1 Participants (2.4g IV)
Units
Counts
Participants
OG000
Secondary
Proportion of Participants Requiring Mechanical Ventilation Due to COVID-19 (Phase 3 Cohort 2)
Phase 3 (Cohort 2)
There were 0 events in this endpoint. Phase 3 Cohort 2 data was not analyzed for this endpoint as there were 0 events in in this cohort
Posted
Number
Percent
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo)
OG001
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV)
OG002
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV)
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 1 - 1.2g vs. Placebo)
Phase 3 Cohort 1
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Mean
Standard Deviation
log10 copies/mL
Baseline up to Day 29
ID
Title
Description
OG000
Phase 3 Cohort 1 Placebo
Modified Full Analysis Set (mFAS) of Next Phase 3 Cohort 1 Participants
OG001
Phase 3 Cohort 1 (1.2g IV)
Phase 3 Cohort 1 Pediatric Participants Modified Full Analysis Set (mFAS)
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 1 - 2.4g vs. Placebo)
Phase 3 Cohort 1
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Mean
Standard Deviation
log10 copies/mL
Baseline up to Day 29
ID
Title
Description
OG000
Phase 3 Cohort 1 Placebo
Modified Full Analysis Set (mFAS) of Next Phase 3 Cohort 1 Participants
OG001
Phase 3 Cohort 1 (2.4g IV)
Phase 3 Cohort 1 Pediatric Participants Modified Full Analysis Set (mFAS)
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Viral Load at Each Visit, as Measured by RT-qPCR in Nasopharyngeal Swabs - (Phase 3 Cohort 2)
Phase 3 Cohort 2
Participants <18 years old who, at baseline, were not pregnant, had symptomatic COVID-19, and had at least 1 risk factor for developing severe disease
Posted
Mean
Standard Deviation
log10 copies/mL
Baseline up to Day 29
ID
Title
Description
OG000
Phase 3 Cohort 2 Placebo
Modified Full Analysis Set (mFAS) of Next Phase 3 Cohort 2 Participants
OG001
Phase 3 Cohort 2 (1.2g IV)
Phase 3 Cohort 2 (1.2g IV) Pediatric Participants Modified Full Analysis Set (mFAS)
OG002
Phase 3 Cohort 2 (2.4g IV)
Modified Full Analysis Set (mFAS) of Phase 3 Cohort (2.4g IV) Participants
Units
Counts
Participants
Secondary
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL), as Measured by Quantitative Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) in Nasopharyngeal (NP) Swab Samples (Ph3 Cohort 1)
Phase 3 (Cohort 1)
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Mean
Standard Deviation
log10 copies/mL
Baseline to Day 7
ID
Title
Description
OG000
Phase 3 Cohort 1 Placebo
(Placebo) Participants who were ≥18 and not pregnant at time of randomization
OG001
Phase 3 Cohort 1 2.4g IV
(2.4g IV) Participants who were ≥18 and not pregnant at time of randomization
OG002
Phase 3 Cohort 1 8.0g IV
(8.0g IV) Participants who were ≥18 and not pregnant at time of randomization
Units
Secondary
Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL), as Measured by Quantitative Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) in Nasopharyngeal (NP) Swab Samples (Ph3 Cohort 2)
Phase 3 (Cohort 2)
Participants <18 years old who, at baseline, were not pregnant, had symptomatic COVID-19, and had at least 1 risk factor for developing severe disease
Posted
Mean
Standard Deviation
log10 copies/mL
Baseline to Day 7
ID
Title
Description
OG000
Phase 3 Cohort 2 Placebo
(Placebo) Participants who were less than 18 and not pregnant at time of randomization
OG001
Phase 3 Cohort 2 (1.2g IV)
(1.2g IV) Participants who were less than 18 and not pregnant at time of randomization
OG002
Phase 3 Cohort 2 (2.4g IV)
(2.4g IV) Participants who were less than 18 and not pregnant at time of randomization
Units
Counts
Secondary
Proportion of Participants With Viral Loads Below the Lower Limit of Detection at Each Visit - (Phase 2 Only)
Next Phase 2 Symptomatic
Participants analyzed are part of modified Full Analysis Set (mFAS) and have documented status at baseline. Next Phase 2 participants included the next 524 participants randomized to Phase 2 subsequent to the first 275 symptomatic participants randomized in Phase 1 / 2
Posted
Count of Participants
Participants
Day 0, Day 5, Day 7, Day 15, Day 29
ID
Title
Description
OG000
Next Phase 2 (Placebo)
Next Phase 2 Placebo Participants
OG001
Next Phase 2 (2.4g IV)
Next Phase 2 Participants 2.4g IV
OG002
Next Phase 2 (8.0g IV)
Next Phase 2 Participants 8.0g IV
Units
Counts
Participants
Secondary
Proportion of Participants With Viral Loads Below the Lower Limit of Quantitation at Each Visit - (Phase 2 Only)
Next Phase 2 Symptomatic
Participants analyzed are part of modified Full Analysis Set (mFAS) and have documented status at baseline. Next Phase 2 participants included the next 524 participants randomized to Phase 2 subsequent to the first 275 symptomatic participants randomized in Phase 1 / 2
Posted
Count of Participants
Participants
Day 0, Day 5, Day 7, Day 15, Day 29
ID
Title
Description
OG000
Next Phase 2 (Placebo)
Next Phase 2 Placebo Participants
OG001
Next Phase 2 (2.4g IV)
Next Phase 2 Participants 2.4g IV
OG002
Next Phase 2 (8.0g IV)
Next Phase 2 Participants 8.0g IV
Units
Counts
Participants
Secondary
Number of Days of Hospitalization Due to COVID-19 (Ph3 Cohort 1) Placebo vs. 1.2g IV
Phase 3 (Cohort 1)
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Mean
Standard Deviation
Days
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo)
Modified Full Analysis Set (mFAS) of Next Phase 3 Cohort 1 Participants
OG001
Phase 3 Cohort 1 1.2g IV
Modified Full Analysis Set (mFAS) of Next Phase 3 Cohort 1 Participants 1.2g IV
Units
Counts
Participants
OG000
Secondary
Number of Days of Hospitalization Due to COVID-19 (Ph3 Cohort 1) Placebo vs. 2.4g IV
Phase 3 (Cohort 1)
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Mean
Standard Deviation
Days
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo)
Phase 3 Cohort 1 (Placebo)
OG001
Phase 3 Cohort 1 Pediatric (2.4g IV)
Phase 3 Cohort 1 Pediatric (2.4g IV)
Units
Counts
Participants
OG000
Secondary
Number of Days of Hospitalization Due to COVID-19 (Ph3 Cohort 2)
Phase 3 (Cohort 2)
Participants <18 years old who, at baseline, were not pregnant, had symptomatic COVID-19, and had at least 1 risk factor for developing severe disease. No participants were hospitalized, therefore no hospitalizations days took place.
Posted
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo) modified Full Analysis Set (mFAS)
OG001
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV) modified Full Analysis Set (mFAS)
OG002
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV) modified Full Analysis Set (mFAS)
Units
Counts
Participants
Secondary
Number of Days of Hospitalization Due to COVID-19 (Phase 2 Asymptomatic)
Phase 2 Only
Phase 2 asymptomatic cohort. No participants were hospitalized, therefore no hospitalizations days took place.
Posted
Up to Day 29
ID
Title
Description
OG000
Placebo
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
OG001
Phase 2 Asymptomatic: 2.4 IV
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
OG002
Phase 2 Asymptomatic: 8.0 IV
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
Units
Counts
Participants
OG000
Secondary
Proportion of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Ph 3 Cohort 1) Placebo vs. 1.2g IV
Phase 3 (Cohort 1)
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Number
95% Confidence Interval
Proportion of Participants
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo)
Symptomatic Participants with COVID-19
OG001
Phase 3 Cohort 1 (1.2g IV)
Phase 3 Cohort 1 (1.2g IV)
Units
Counts
Participants
OG000
Secondary
Percentage of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Ph 3 Cohort 1) Placebo vs. 2.4g IV
Phase 3 (Cohort 1)
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Number
95% Confidence Interval
Percentage of Participants
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 1 (Placebo)
Phase 3 Cohort 1 (Placebo)
OG001
Phase 3 Cohort 1 (2.4g IV)
Phase 3 Cohort 1 (2.4g IV)
Units
Counts
Participants
OG000
Secondary
Proportion of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Ph 3 Cohort 2)
Phase 3 (Cohort 2)
Participants <18 years old who, at baseline, were not pregnant, had symptomatic COVID-19, and had at least 1 risk factor for developing severe disease
Posted
Number
Participants
Through Day 29
ID
Title
Description
OG000
Phase 3 Cohort 2 Pediatric (Placebo)
Phase 3 Cohort 2 Pediatric (Placebo) modified Full Analysis Set (mFAS)
OG001
Phase 3 Cohort 2 Pediatric (1.2g IV)
Phase 3 Cohort 2 Pediatric (1.2g IV) modified Full Analysis Set (mFAS)
OG002
Phase 3 Cohort 2 Pediatric (2.4g IV)
Phase 3 Cohort 2 Pediatric (2.4g IV) modified Full Analysis Set (mFAS)
Units
Counts
Participants
Secondary
Proportion of Participants Admitted to an Intensive Care Unit (ICU) Due to COVID-19 - (Next Phase 2) #87
Next Phase 2
Participants analyzed are part of modified Full Analysis Set (mFAS) and have documented status at baseline. Next Phase 2 participants included the next 524 participants randomized to Phase 2 subsequent to the first 275 symptomatic participants randomized in Phase 1 / 2
Posted
Number
Participants
Through Day 29
ID
Title
Description
OG000
Next Phase 2 (Placebo)
Next Phase 2 Placebo Participants
OG001
Next Phase 2 (2.4g IV)
Next Phase 2 Participants 2.4g IV
OG002
Next Phase 2 (8.0g IV)
Next Phase 2 Participants 8.0g IV
Units
Counts
Participants
Secondary
Total Number of COVID-19-related Medically-attended Visits (Phase 3 Cohort 1) Placebo vs. 1.2g
Phase 3 Cohort 1
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Mean
Standard Deviation
Number of Visits
Through Day 29
ID
Title
Description
OG000
Placebo
Placebo mFAS (modified Full Analysis Set)
OG001
Phase 3 Cohort 1 1.2g IV
Phase 3 Cohort 1 1.2 g IV mFAS (modified Full Analysis Set)
Units
Counts
Participants
OG000
Secondary
Total Number of COVID-19-related Medically-attended Visits (Phase 3 Cohort 1) Placebo vs. 2.4g
Phase 3 Cohort 1
Participants that were ≥18 years old and not pregnant at randomization, and randomized on or before 17-Jan-2021 with detectable SARS-CoV-2 RNA by RT-qPCR in nasopharyngeal swabs at randomization and at least 1 risk factor for severe COVID-19 at baseline
Posted
Mean
Standard Deviation
Number of Visits
Through Day 29
ID
Title
Description
OG000
Placebo
Placebo mFAS (modified Full Analysis Set)
OG001
Phase 3 Cohort 1 2.4g IV
Phase 3 Cohort 1 2.4g IV mFAS (modified Full Analysis Set)
Units
Counts
Participants
OG000
Secondary
Total Number of COVID-19-related Medically-attended Visits (Phase 3 Cohort 2)
Phase 3 Cohort 2
Participants <18 years old who, at baseline, were not pregnant, had symptomatic COVID-19, and had at least 1 risk factor for developing severe disease
Posted
Mean
Standard Deviation
Number of Visits
Through Day 29
ID
Title
Description
OG000
Placebo
Placebo mFAS (modified Full Analysis Set)
OG001
Phase 3 Cohort 2 1.2g IV
Phase 3 Cohort 2 1.2g IV mFAS (modified Full Analysis Set)
OG002
Phase 3 Cohort 2 2.4g IV
Phase 3 Cohort 2 2.4g IV mFAS (modified Full Analysis Set)
Units
Counts
Participants
OG000
Time Frame
From first dose to end of study (approx. 8 months)
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 Symptomatic Placebo
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
0
24
0
24
0
24
EG001
Phase 1 Symptomatic R10933+R10987 2.4g IV
2.4g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
0
22
1
22
0
22
EG002
Phase 1 Symptomatic R10933+R10987 8.0g IV
8.0g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
0
23
0
23
0
23
EG003
Phase 2 Symptomatic Placebo
Placebo of R10933 + R10987 Adult Symptomatic Participants with COVID-19
0
238
6
238
2
238
EG004
Phase 2 Symptomatic R10933+R10987 2.4g IV
2.4g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
0
236
3
236
1
236
EG005
Phase 2 Symptomatic R10933+R10987 8.0g IV
8.0g of R10933 + R10987 Adult Symptomatic Participants with COVID-19
0
237
2
237
1
237
EG006
Phase 2 Asymptomatic Placebo
Placebo of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
0
73
0
73
0
73
EG007
Phase 2 Asymptomatic R10933+R10987 2.4g IV
2.4g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
0
74
0
74
0
74
EG008
Phase 2 Asymptomatic R10933+R10987 8.0g IV
8.0g of R10933 + R10987 Adult Participants with asymptomatic SARS-CoV-2 infection
0
75
0
75
0
75
EG009
Phase 3 Age>=18 Placebo
Placebo of R10933 + R10987 Participants >=18 with COVID-19, not pregnant at randomization
11
2,347
103
2,347
16
2,347
EG010
Phase 3 Age>=18 R10933+R10987 1.2g IV
1.2g of R10933 + R10987 Participants >=18 with COVID-19, not pregnant at randomization
2
2,130
39
2,130
16
2,130
EG011
Phase 3 Age>=18 R10933+R10987 2.4g IV
2.4g of R10933 + R10987 Participants >=18 with COVID-19, not pregnant at randomization
4
3,157
52
3,157
19
3,157
EG012
Phase 3 Age>=18 R10933+R10987 8.0g IV
8.0g of R10933 + R10987 Participants >=18 with COVID-19, not pregnant at randomization
0
1,012
19
1,012
4
1,012
EG013
Phase 3 Age<18 Placebo
Placebo of R10933 + R10987 Participants <18 with COVID-19, not pregnant at randomization
0
2
0
2
1
2
EG014
Phase 3 Age<18 R10933+R10987 1.2g IV
1.2g of R10933 + R10987 Participants <18 with COVID-19
0
129
3
129
0
129
EG015
Phase 3 Age<18 R10933+R10987 2.4g IV
2.4g of R10933 + R10987 Participants <18 with COVID-19
0
71
0
71
1
71
EG016
Phase 3 Pregnant Placebo
Placebo of R10933 + R10987 Participants who are pregnant with COVID-19
0
2
0
2
0
2
EG017
Phase 3 Pregnant R10933+R10987 1.2g IV
1.2g of R10933 + R10987 Participants who are pregnant with COVID-19
0
43
11
43
5
43
EG018
Phase 3 Pregnant R10933+R10987 2.4g IV
2.4g of R10933 + R10987 Participants who are pregnant with COVID-19
0
35
7
35
3
35
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG0030 events0 affected238 at risk
EG0040 events0 affected236 at risk
EG0050 events0 affected237 at risk
EG0060 events0 affected73 at risk
EG0070 events0 affected74 at risk
EG0080 events0 affected75 at risk
EG0091 events1 affected2,347 at risk
EG0100 events0 affected2,130 at risk
EG0110 events0 affected3,157 at risk
EG0120 events0 affected1,012 at risk
EG0130 events0 affected2 at risk
EG0140 events0 affected129 at risk
EG0150 events0 affected71 at risk
EG0160 events0 affected2 at risk
EG0170 events0 affected43 at risk
EG0180 events0 affected35 at risk
Immune thrombocytopenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Arrhythmia neonatal
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Cardiac failure acute
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Mitral valve calcification
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Anal atresia
Congenital, familial and genetic disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Craniosynostosis
Congenital, familial and genetic disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Foetal malformation
Congenital, familial and genetic disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Macrocephaly
Congenital, familial and genetic disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Tracheo-oesophageal fistula
Congenital, familial and genetic disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Abdominal wall haematoma
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Colitis ischaemic
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Diverticulum
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Peptic ulcer perforation
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Death
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Fever neonatal
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Impaired healing
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Pyrexia
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Hyperbilirubinaemia neonatal
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Abscess
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Abscess neck
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Breast abscess
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
COVID-19
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Kidney infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Lung abscess
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Metapneumovirus pneumonia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Sepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Acetabulum fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Cervical vertebral fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Fractured sacrum
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Gastrointestinal anastomotic stenosis
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Continuous glucose monitoring
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Rectal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Haemorrhagic stroke
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Hyporesponsive to stimuli
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Migraine
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Abnormal labour
Pregnancy, puerperium and perinatal conditions
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Ectopic pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Foetal growth restriction
Pregnancy, puerperium and perinatal conditions
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Pre-eclampsia
Pregnancy, puerperium and perinatal conditions
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Premature baby
Pregnancy, puerperium and perinatal conditions
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Premature separation of placenta
Pregnancy, puerperium and perinatal conditions
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Preterm premature rupture of membranes
Pregnancy, puerperium and perinatal conditions
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Ruptured ectopic pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Bipolar disorder
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Depression
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Perinatal depression
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Abnormal uterine bleeding
Reproductive system and breast disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Haemothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Pneumothorax spontaneous
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Pulmonary congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Pulmonary mass
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Hospitalisation
Surgical and medical procedures
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Hypertension
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
May-Thurner syndrome
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG0030 events0 affected238 at risk
EG0040 events0 affected236 at risk
EG0050 events0 affected237 at risk
EG0060 events0 affected73 at risk
EG0070 events0 affected74 at risk
EG0080 events0 affected75 at risk
EG0090 events0 affected2,347 at risk
EG0100 events0 affected2,130 at risk
EG0117 events7 affected3,157 at risk
EG0121 events1 affected1,012 at risk
EG0130 events0 affected2 at risk
EG0140 events0 affected129 at risk
EG0151 events1 affected71 at risk
EG0160 events0 affected2 at risk
EG0173 events3 affected43 at risk
EG0180 events0 affected35 at risk
Gestational diabetes
Pregnancy, puerperium and perinatal conditions
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Nasal and saliva sample collection was discontinued early in the study because nasopharyngeal samples were determined to be more reliable for quantitative analysis, as such endpoints related to nasal or saliva samples were not analyzed. The Phase 1/2 SAP does not specify any analyses related to nasal and saliva samples collections
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.