Study in Participants With Early Stage Coronavirus Diseas... | NCT04539262 | Trialant
NCT04539262
Sponsor
Gilead Sciences
Status
Completed
Last Update Posted
Mar 3, 2022Actual
Enrollment
156Actual
Phase
Phase 1Phase 2
Conditions
COVID-19
Interventions
Remdesivir (RDV)
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT04539262
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GS-US-553-9020
Secondary IDs
Not provided
Brief Title
Study in Participants With Early Stage Coronavirus Disease 2019 (COVID-19) to Evaluate the Safety, Efficacy, and Pharmacokinetics of Remdesivir Administered by Inhalation
Official Title
A Phase 1b/2a Study in Participants With Early Stage COVID-19 to Evaluate the Safety, Efficacy, and Pharmacokinetics of Remdesivir Administered by Inhalation
Acronym
Not provided
Organization
Gilead SciencesINDUSTRY
Status Module
Record Verification Date
Feb 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 14, 2020Actual
Primary Completion Date
Feb 26, 2021Actual
Completion Date
Mar 22, 2021Actual
First Submitted Date
Aug 26, 2020
First Submission Date that Met QC Criteria
Sep 3, 2020
First Posted Date
Sep 4, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Feb 18, 2022
Results First Submitted that Met QC Criteria
Feb 18, 2022
Results First Posted Date
Mar 3, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 18, 2022
Last Update Posted Date
Mar 3, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Gilead SciencesINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary objective of this study is to characterize the impact of inhaled remdesivir (RDV) on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load in participants with early stage coronavirus disease 2019 (COVID-19).
Detailed Description
This study will have multiple parts: Part A, Part B, and Part C. Part B will be conducted if supported by evaluation in healthy volunteers in another Phase 1a Gilead study (GS-US-553-9018). Participants in Part C will be enrolled after review of preliminary safety and available efficacy data from Parts A and B through at least Day 7.
GS-US-553-9018 is a Phase 1a randomized, blinded, placebo-controlled, single- and multiple-dose study in healthy volunteers to evaluate the safety, tolerability, and pharmacokinetics of remdesivir administered by inhalation.
Conditions Module
Conditions
COVID-19
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
156Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Remdesivir (RDV), Part A
Experimental
Participants will receive inhaled RDV 31 mg administered daily for 5 days.
Drug: Remdesivir (RDV)
RDV + Placebo, Part A
Experimental
Participants will receive inhaled RDV 31 mg administered daily for 3 days followed by placebo to match RDV daily for 2 days.
Drug: Remdesivir (RDV)
Drug: Placebo
Placebo, Part A
Placebo Comparator
Participants will receive placebo to match inhaled RDV in Part A daily for 5 days.
Drug: Placebo
RDV, Part B
Experimental
Participants will receive inhaled RDV 62 mg administered daily for up to 5 days.
Drug: Remdesivir (RDV)
RDV + Placebo, Part B
Experimental
Participants will receive inhaled RDV 62 mg administered daily for up to 3 days followed by placebo to match RDV daily for 2 days.
Drug: Remdesivir (RDV)
Drug: Placebo
Placebo, Part B
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Remdesivir (RDV)
Drug
Administered as an aerosolized solution
RDV + Placebo, Part A
RDV + Placebo, Part B
RDV, Part B
RDV, Part C
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Time-weighted Average Change From Baseline in Nasopharyngeal Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Through Day 7
Time-weighted average change in SARS-CoV-2 viral load was defined as area under the concentration versus time curve (AUC) of viral load change divided by time between baseline through Day 7.
Baseline, Day 7
Time-weighted Average Change From Baseline in Oropharyngeal SARS-CoV-2 Viral Load Through Day 7
Time-weighted average change in SARS-CoV-2 viral load was defined as AUC of viral load change divided by time between baseline through Day 7.
Baseline, Day 7
Time-weighted Average Change From Baseline in Saliva SARS-CoV-2 Viral Load Through Day 7
Time-weighted average change in SARS-CoV-2 viral load was defined as AUC of viral load change divided by time between baseline through Day 7.
Baseline, Day 7
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant administered a study drug, which did not necessarily have a causal relationship with the treatment. AE was therefore any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. TEAEs: AE with an onset date on or after the study drug start date and no later than 30 days after study drug stop date; or any AE leading to study drug discontinuation.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Willing and able to provide written informed consent, or with a legal representative who can provide informed consent
SARS-CoV-2 infection first confirmed by polymerase chain reaction (PCR) (Parts A and B) or by nucleic acid testing or direct antigen testing (Part C) with sample collected ≤ 4 days prior to randomization
COVID-19 symptom onset ≤ 7 days prior to randomization
Oxygen saturation as measured by pulse oximetry (SpO2) > 94% on room air
Key Exclusion Criteria:
Ongoing or prior participation in any other clinical trial of an experimental vaccine or treatment for COVID-19
Prior or current hospitalization for COVID-19 or need for hospitalization
Treatment of COVID-19 with other agents with actual or possible direct antiviral activity against SARS-CoV-2 including intravenous (IV) RDV or administration of any SARS-CoV-2 (or COVID-19) vaccine
Participants chronically administered chloroquine or hydroxychloroquine for any reason are to be excluded
Requiring oxygen supplementation
Positive pregnancy test
Breastfeeding female
Known hypersensitivity to the study treatment, its metabolites, or formulation excipient
Pre-existing pulmonary conditions such as chronic obstructive pulmonary disease or asthma (Parts A and B only)
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Gilead Study Director
Gilead Sciences
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
The Institute for Liver Health
Mesa
Arizona
85210
United States
The Institute for Liver Health
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
168 participants were screened.
Recruitment Details
Participants were enrolled at study sites in the United States. The first participant was screened on 14 September 2020. The last study visit occurred on 22 March 2021.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Remdesivir (RDV), Part A
Participants received inhaled remdesivir (RDV) 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
FG001
RDV + Placebo, Part A
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jan 13, 2021
Jan 17, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Placebo Comparator
Participants will receive placebo to match inhaled RDV in Part B daily for 5 days.
Drug: Placebo
RDV, Part C
Experimental
Participants will receive inhaled RDV 39 mg administered daily for 5 days.
Drug: Remdesivir (RDV)
Placebo, Part C
Placebo Comparator
Participants will receive placebo to match inhaled RDV in Part C daily for 5 days.
Drug: Placebo
Remdesivir (RDV), Part A
GS-5734â„¢
Placebo
Drug
Administered as an aerosolized solution
Placebo, Part A
Placebo, Part B
Placebo, Part C
RDV + Placebo, Part A
RDV + Placebo, Part B
First dose date up to 5 days plus 30 days
Percentage of Participants With Treatment-Emergent Laboratory Abnormalities as Per Severity Grade
Treatment-emergent laboratory abnormalities were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 July 2017. Laboratory abnormalities were graded as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening). Percentage of participants with any severity grade were reported.
First dose date up to 5 days plus 30 days
Percentage of Participants With Treatment-Emergent Adverse Events Leading to Study Treatment Discontinuation
First dose date up to 5 days plus 30 days
Number of Participants With All-Cause Medically Attended Visits (MAVs) or Death by Day 28
The composite outcome of all-cause MAVs (medical visits attended in person by the participant and a health care professional) or all-cause death by Study Day 28 were estimated using Kaplan-Meier methods by treatment group.
Randomization up to Day 28
Number of Participants With COVID-19 Related MAVs or Death by Day 28
The composite outcome of COVID-19 related MAVs (medical visits attended in person by the participant and a health care professional) or all-cause death by Study Day 28 were estimated using Kaplan-Meier methods by treatment group.
Randomization up to Day 28
Number of Participants With Hospitalization by Day 28
The composite of all-cause hospitalization was estimated using Kaplan-Meier methods by treatment group.
Day 1 up to Day 28
Pharmacokinetic (PK) Parameter: AUC0-24h of Remdesivir (RDV) and Its Metabolites (GS-441524 and GS-704277) in Parts A and B
AUC0-24h was defined as the concentration of drug over time between time 0 to time 24 hours. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.
PK Parameter: AUClast of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B
AUClast was defined as the concentration of drug from time zero to the last observable concentration.Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.
PK Parameter: CLss/F of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B
CLss/F was defined as apparent oral clearance at steady state after administration of the drug. CLss/F = Dose/AUCtau, where "Dose" is the dose of the drug. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.
PK Parameter: t1/2 of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B
t1/2 was defined as the estimate of the terminal elimination half-life of the drug. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.
PK Parameter: Vz/F of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B
Vz/F was defined as the apparent volume of distribution of the drug. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.
PK Parameter: Cmax of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B
Cmax was defined as the maximum observed concentration of drug.Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.
PK Parameter: Tmax of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B
Tmax was defined as the time (observed time point) of Cmax. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.
PK Parameter: Clast of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B
Clast was defined as the last observable concentration of drug. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.
PK Parameter: Tlast of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B
Tlast was defined as the time (observed time point) of Clast. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.
PK Parameter: AUCtau of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B
AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval). Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.
PK Parameter: λz of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B
λz was defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.
PK Parameter: Ctau of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B
Ctau was defined as the observed drug concentration at the end of the dosing interval. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.
Change in Nasopharyngeal SARS-CoV-2 Viral Load From Baseline to Day 5
Baseline, Day 5
Change in Oropharyngeal SARS-CoV-2 Viral Load From Baseline to Day 5
Baseline, Day 5
Change in Saliva SARS-CoV-2 Viral Load From Baseline to Day 5
Baseline, Day 5
Change in Nasopharyngeal SARS-CoV-2 Viral Load From Baseline to Day 7
Baseline, Day 7
Change in Oropharyngeal SARS-CoV-2 Viral Load From Baseline to Day 7
Baseline, Day 7
Change in Saliva SARS-CoV-2 Viral Load From Baseline to Day 7
Baseline, Day 7
Change in Nasopharyngeal SARS-CoV-2 Viral Load From Baseline to Day 14 in Parts A and B
Baseline, Day 14
Change in Oropharyngeal SARS-CoV-2 Viral Load From Baseline to Day 14 in Parts A and B
Baseline, Day 14
Change in Saliva SARS-CoV-2 Viral Load From Baseline to Day 14 in Parts A and B
Baseline, Day 14
Time to Negative Nasopharyngeal SARS-CoV-2 Polymerase Chain Reaction (PCR)
The time to negative nasopharyngeal SARS-CoV-2 PCR was defined as the number of days to first confirmed negative (first date of two consecutive dates achieving negative result) using nasopharyngeal sample. Time to negative nasopharyngeal SARS-CoV-2 PCR was calculated using Kaplan-Meier estimates.
Baseline up to Day 17
Time to Negative Oropharyngeal SARS-CoV-2 Polymerase Chain Reaction (PCR)
The time to negative oropharyngeal SARS-CoV-2 PCR was defined as the number of days to first confirmed negative (first date of two consecutive dates achieving negative result) using an oropharyngeal sample. Time to negative oropharyngeal SARS-CoV-2 PCR was calculated using Kaplan-Meier estimates.
Baseline up to Day 17
Time to Negative Saliva SARS-CoV-2 Polymerase Chain Reaction (PCR)
The time to saliva SARS-CoV-2 PCR was defined as the number of days to first confirmed negative (first date of two consecutive dates achieving negative result) using saliva sample. Time to negative saliva SARS-CoV-2 PCR was calculated using Kaplan-Meier estimates.
Westchester Research Center at Westchester General Hospital
Miami
Florida
33155
United States
MedBio Trials
Miami
Florida
33180
United States
Nuovida Research Center, Corp
Miami
Florida
33186
United States
IMIC Inc
Palmetto Bay
Florida
33157
United States
Triple O Research Institute, PA
West Palm Beach
Florida
33401
United States
Family Care Research
Boise
Idaho
83704
United States
CTU Covid Research Center
New Orleans
Louisiana
70112
United States
STAT Research
Vandalia
Ohio
45066
United States
Inquest Clinical Research
Baytown
Texas
77521
United States
DFW Clinical Research
Dallas
Texas
75234
United States
Baylor Research Institute
Dallas
Texas
75246
United States
PCP for Life-Tidwell
Houston
Texas
77093
United States
Providence Regional Medical Center Everett
Everett
Washington
98201
United States
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
FG002
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
FG003
RDV, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
FG004
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
FG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
FG006
RDV, Part C
Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.
FG007
Placebo, Part C
Participants received placebo to match inhaled RDV in Part C daily for 5 days.
FG00012 subjects
FG00113 subjects
FG00212 subjects
FG00312 subjects
FG00412 subjects
FG00513 subjects
FG00662 subjects
FG00720 subjects
COMPLETED
FG00012 subjects
FG00112 subjects
FG00211 subjects
FG00311 subjects
FG00412 subjects
FG00513 subjects
FG00661 subjects
FG00720 subjects
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Withdrew Consent
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Randomized, Not treated
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
BG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
BG002
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
BG003
RDV, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
BG004
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
BG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
BG006
RDV, Part C
Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.
BG007
Placebo, Part C
Participants received placebo to match inhaled RDV in Part C daily for 5 days.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00012
BG00112
BG00212
BG00312
BG00412
BG00513
BG00661
BG00720
BG008154
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
< 60 years
ParticipantsBG00012
ParticipantsBG00112
ParticipantsBG00212
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG00012
ParticipantsBG00112
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG00012
ParticipantsBG00112
ParticipantsBG002
Race/Ethnicity, Customized
Not Permitted means local regulators did not allow collection of race information.
Count of Participants
Participants
No
Title
Denominators
Categories
Race
ParticipantsBG00012
ParticipantsBG00112
ParticipantsBG002
SARS-CoV-2 Viral load - Nasopharyngeal
Participants in the Safety Analysis Set with available data were analyzed.
Mean
Standard Deviation
log10 copies/mL
Title
Denominators
Categories
ParticipantsBG00012
ParticipantsBG00111
ParticipantsBG002
SARS-CoV-2 Viral load - Oropharyngeal
Participants in the Safety Analysis Set with available data were analyzed.
Mean
Standard Deviation
log10 copies/mL
Title
Denominators
Categories
ParticipantsBG00011
ParticipantsBG00111
ParticipantsBG002
SARS-CoV-2 Viral load - Saliva
Participants in the Safety Analysis Set with available data were analyzed.
Mean
Standard Deviation
log10 copies/mL
Title
Denominators
Categories
ParticipantsBG00010
ParticipantsBG00111
ParticipantsBG002
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
Time-weighted Average Change From Baseline in Nasopharyngeal Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Through Day 7
Time-weighted average change in SARS-CoV-2 viral load was defined as area under the concentration versus time curve (AUC) of viral load change divided by time between baseline through Day 7.
Participants in the Nasopharyngeal Modified Full Analysis Set (mFAS) (all participants who were randomized into the study, had received at least 1 dose of study treatment and had positive SARS-CoV-2 viral load using nasopharyngeal swab sample at baseline [the result of 'No SARS-CoV-2 detected' was considered as negative]) with available data were analyzed.
Posted
Mean
Standard Deviation
log10 copies/mL
Baseline, Day 7
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG002
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
OG003
RDV, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG004
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
OG006
RDV, Part C
Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.
OG007
Placebo, Part C
Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Units
Counts
Participants
OG00011
OG00111
OG00211
OG003
Title
Denominators
Categories
Title
Measurements
OG000-2.04± 0.999
OG001-1.51± 0.812
OG002-1.24± 0.961
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
ANCOVA
0.1117
Least square (LS) Mean, Standard Error (SE), 95% CI and p-value were from Analysis of covariance (ANCOVA) with baseline viral load as a covariate.
Least Square Mean Difference by Day 7
-0.66
Standard Error of the Mean
0.40
2-Sided
95
-1.49
0.16
Superiority
OG001
OG002
Primary
Time-weighted Average Change From Baseline in Oropharyngeal SARS-CoV-2 Viral Load Through Day 7
Time-weighted average change in SARS-CoV-2 viral load was defined as AUC of viral load change divided by time between baseline through Day 7.
Participants in the Oropharyngeal mFAS (all participants who were randomized into the study, had received at least 1 dose of study treatment and had positive SARS-CoV-2 viral load using oropharyngeal swab sample at baseline [the result of 'No SARS-CoV-2 detected' was considered as negative]) with available data were analyzed.
Posted
Mean
Standard Deviation
log10 copies/mL
Baseline, Day 7
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG002
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
Primary
Time-weighted Average Change From Baseline in Saliva SARS-CoV-2 Viral Load Through Day 7
Time-weighted average change in SARS-CoV-2 viral load was defined as AUC of viral load change divided by time between baseline through Day 7.
Participants in the saliva mFAS (all participants who were randomized into the study, had received at least 1 dose of study treatment and had positive SARS-CoV-2 viral load using saliva swab sample at baseline [the result of 'No SARS-CoV-2 detected' was considered as negative]) with available data were analyzed.
Posted
Mean
Standard Deviation
log10 copies/mL
Baseline, Day 7
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG002
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
OG003
Secondary
Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant administered a study drug, which did not necessarily have a causal relationship with the treatment. AE was therefore any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. TEAEs: AE with an onset date on or after the study drug start date and no later than 30 days after study drug stop date; or any AE leading to study drug discontinuation.
The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment.
Posted
Number
percentage of participants
First dose date up to 5 days plus 30 days
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG002
Placebo, Part A
Secondary
Percentage of Participants With Treatment-Emergent Laboratory Abnormalities as Per Severity Grade
Treatment-emergent laboratory abnormalities were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 July 2017. Laboratory abnormalities were graded as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening). Percentage of participants with any severity grade were reported.
Participants in the Safety Analysis Set with available data were analyzed.
Posted
Number
percentage of participants
First dose date up to 5 days plus 30 days
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG002
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
Secondary
Percentage of Participants With Treatment-Emergent Adverse Events Leading to Study Treatment Discontinuation
Participants in the Safety Analysis Set were analyzed.
Posted
Number
percentage of participants
First dose date up to 5 days plus 30 days
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG002
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
OG003
RDV, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG004
Secondary
Number of Participants With All-Cause Medically Attended Visits (MAVs) or Death by Day 28
The composite outcome of all-cause MAVs (medical visits attended in person by the participant and a health care professional) or all-cause death by Study Day 28 were estimated using Kaplan-Meier methods by treatment group.
Participants in the Full Analysis Set (all participants who were randomized into the study, and had received at least 1 dose of study treatment) were analyzed.
Posted
Count of Participants
Participants
No
Randomization up to Day 28
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG002
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
OG003
RDV, Part B
Secondary
Number of Participants With COVID-19 Related MAVs or Death by Day 28
The composite outcome of COVID-19 related MAVs (medical visits attended in person by the participant and a health care professional) or all-cause death by Study Day 28 were estimated using Kaplan-Meier methods by treatment group.
Participants in the Full Analysis Set were analyzed.
Posted
Count of Participants
Participants
No
Randomization up to Day 28
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG002
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
OG003
RDV, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
Secondary
Number of Participants With Hospitalization by Day 28
The composite of all-cause hospitalization was estimated using Kaplan-Meier methods by treatment group.
Participants in the Full Analysis Set were analyzed.
Posted
Count of Participants
Participants
No
Day 1 up to Day 28
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG002
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
OG003
RDV, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
Secondary
Pharmacokinetic (PK) Parameter: AUC0-24h of Remdesivir (RDV) and Its Metabolites (GS-441524 and GS-704277) in Parts A and B
AUC0-24h was defined as the concentration of drug over time between time 0 to time 24 hours. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
As only 1 participant was evaluated, results for PK parameters were not reported for the protection of personal data and to avoid re-identification.
Posted
Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
Secondary
PK Parameter: AUClast of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B
AUClast was defined as the concentration of drug from time zero to the last observable concentration.Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
As only 1 participant was evaluated, results for PK parameters were not reported for the protection of personal data and to avoid re-identification.
Posted
Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
Secondary
PK Parameter: CLss/F of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B
CLss/F was defined as apparent oral clearance at steady state after administration of the drug. CLss/F = Dose/AUCtau, where "Dose" is the dose of the drug. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
As only 1 participant was evaluated, results for PK parameters were not reported for the protection of personal data and to avoid re-identification.
Posted
Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
Secondary
PK Parameter: t1/2 of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B
t1/2 was defined as the estimate of the terminal elimination half-life of the drug. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
As only 1 participant was evaluated, results for PK parameters were not reported for the protection of personal data and to avoid re-identification.
Posted
Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG002
Secondary
PK Parameter: Vz/F of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B
Vz/F was defined as the apparent volume of distribution of the drug. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
As only 1 participant was evaluated, results for PK parameters were not reported for the protection of personal data and to avoid re-identification.
Posted
Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG002
Secondary
PK Parameter: Cmax of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B
Cmax was defined as the maximum observed concentration of drug.Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
As only 1 participant was evaluated, results for PK parameters were not reported for the protection of personal data and to avoid re-identification.
Posted
Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG002
Secondary
PK Parameter: Tmax of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B
Tmax was defined as the time (observed time point) of Cmax. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
As only 1 participant was evaluated, results for PK parameters were not reported for the protection of personal data and to avoid re-identification.
Posted
Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG002
Secondary
PK Parameter: Clast of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B
Clast was defined as the last observable concentration of drug. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
As only 1 participant was evaluated, results for PK parameters were not reported for the protection of personal data and to avoid re-identification.
Posted
Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG002
Secondary
PK Parameter: Tlast of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B
Tlast was defined as the time (observed time point) of Clast. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
As only 1 participant was evaluated, results for PK parameters were not reported for the protection of personal data and to avoid re-identification.
Posted
Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG002
Secondary
PK Parameter: AUCtau of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B
AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval). Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
As only 1 participant was evaluated, results for PK parameters were not reported for the protection of personal data and to avoid re-identification.
Posted
Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
Secondary
PK Parameter: λz of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B
λz was defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
As only 1 participant was evaluated, results for PK parameters were not reported for the protection of personal data and to avoid re-identification.
Posted
Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
Secondary
PK Parameter: Ctau of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B
Ctau was defined as the observed drug concentration at the end of the dosing interval. Time Frame for PK samples: Sparse PK (all participants): Day 1 (end of nebulization, and optional 2-hour post nebulization), and Day 3 (predose and end of nebulization); Intensive PK (Up to 6 participants/group in Part A & Part B): Day 1 and an additional sample at Day 3 or Day 5 at the following time points: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization.
As only 1 participant was evaluated, results for PK parameters were not reported for the protection of personal data and to avoid re-identification.
Posted
Sparse PK: Day 1 (end of nebulization) and Day 3 (predose and end of nebulization); Intensive PK: Day 1 and Day 3 or Day 5 (0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, and 24 hours post end of nebulization); Nebulization duration: 17-34 minutes.
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG002
Secondary
Change in Nasopharyngeal SARS-CoV-2 Viral Load From Baseline to Day 5
Participants in the Nasopharyngeal mFAS with available data were analyzed.
Posted
Mean
Standard Deviation
log10 copies/mL
Baseline, Day 5
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG002
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
OG003
RDV, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG004
Secondary
Change in Oropharyngeal SARS-CoV-2 Viral Load From Baseline to Day 5
Participants in the Oropharyngeal mFAS with available data were analyzed.
Posted
Mean
Standard Deviation
log10 copies/mL
Baseline, Day 5
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG002
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
OG003
RDV, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG004
Secondary
Change in Saliva SARS-CoV-2 Viral Load From Baseline to Day 5
Participants in the Saliva mFAS with available data were analyzed.
Posted
Mean
Standard Deviation
log10 copies/mL
Baseline, Day 5
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG002
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
OG003
RDV, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG004
RDV + Placebo, Part B
Secondary
Change in Nasopharyngeal SARS-CoV-2 Viral Load From Baseline to Day 7
Participants in the Nasopharyngeal mFAS with available data were analyzed.
Posted
Mean
Standard Deviation
log10 copies/mL
Baseline, Day 7
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG002
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
OG003
RDV, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG004
Secondary
Change in Oropharyngeal SARS-CoV-2 Viral Load From Baseline to Day 7
Participants in the Oropharyngeal mFAS with available data were analyzed.
Posted
Mean
Standard Deviation
log10copies/mL
Baseline, Day 7
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG002
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
OG003
RDV, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG004
Secondary
Change in Saliva SARS-CoV-2 Viral Load From Baseline to Day 7
Participants in the Saliva mFAS with available data were analyzed.
Posted
Mean
Standard Deviation
log10 copies/mL
Baseline, Day 7
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG002
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
OG003
RDV, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG004
RDV + Placebo, Part B
Secondary
Change in Nasopharyngeal SARS-CoV-2 Viral Load From Baseline to Day 14 in Parts A and B
Participants in the Nasopharyngeal mFAS with available were analyzed.
Posted
Mean
Standard Deviation
log10 copies/mL
Baseline, Day 14
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG002
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
OG003
RDV, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG004
Secondary
Change in Oropharyngeal SARS-CoV-2 Viral Load From Baseline to Day 14 in Parts A and B
Participants in the Oropharyngeal mFAS with available were analyzed.
Posted
Mean
Standard Deviation
log10 copies/mL
Baseline, Day 14
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG002
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
OG003
RDV, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG004
Secondary
Change in Saliva SARS-CoV-2 Viral Load From Baseline to Day 14 in Parts A and B
Participants in the Saliva mFAS with available were analyzed.
Posted
Mean
Standard Deviation
log10 copies/mL
Baseline, Day 14
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG002
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
OG003
RDV, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG004
Secondary
Time to Negative Nasopharyngeal SARS-CoV-2 Polymerase Chain Reaction (PCR)
The time to negative nasopharyngeal SARS-CoV-2 PCR was defined as the number of days to first confirmed negative (first date of two consecutive dates achieving negative result) using nasopharyngeal sample. Time to negative nasopharyngeal SARS-CoV-2 PCR was calculated using Kaplan-Meier estimates.
Participants in the Nasopharyngeal mFAS with available data were analyzed.
Posted
Median
95% Confidence Interval
days
Baseline up to Day 17
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG002
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
OG003
RDV, Part B
Secondary
Time to Negative Oropharyngeal SARS-CoV-2 Polymerase Chain Reaction (PCR)
The time to negative oropharyngeal SARS-CoV-2 PCR was defined as the number of days to first confirmed negative (first date of two consecutive dates achieving negative result) using an oropharyngeal sample. Time to negative oropharyngeal SARS-CoV-2 PCR was calculated using Kaplan-Meier estimates.
Participants in the Oropharyngeal mFAS with available data were analyzed.
Posted
Median
95% Confidence Interval
days
Baseline up to Day 17
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG002
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
OG003
RDV, Part B
Secondary
Time to Negative Saliva SARS-CoV-2 Polymerase Chain Reaction (PCR)
The time to saliva SARS-CoV-2 PCR was defined as the number of days to first confirmed negative (first date of two consecutive dates achieving negative result) using saliva sample. Time to negative saliva SARS-CoV-2 PCR was calculated using Kaplan-Meier estimates.
Participants in the Saliva mFAS with available data were analyzed.
Posted
Median
95% Confidence Interval
days
Baseline up to Day 17
ID
Title
Description
OG000
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG002
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
Participants in FAS with available data were analyzed.
Posted
Median
95% Confidence Interval
days
First dose date up to Day 14
ID
Title
Description
OG000
RDV, Part C
Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.
OG001
Placebo, Part C
Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Time Frame
Adverse Events: First dose date up to 5 days plus 30 days All-Cause Mortality: Randomization date up to 35 days
Description
Adverse Events: The Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment.
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
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
RDV, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
0
12
0
12
7
12
EG001
RDV + Placebo, Part A
Participants received inhaled RDV 31 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
0
13
1
12
7
12
EG002
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
0
12
2
12
5
12
EG003
RDV, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
0
12
0
12
4
12
EG004
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
0
12
1
12
6
12
EG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
0
13
1
13
5
13
EG006
RDV, Part C
Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.
0
62
0
61
24
61
EG007
Placebo, Part C
Participants received placebo to match inhaled RDV in Part C daily for 5 days.
0
20
0
20
5
20
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0021 affected12 at risk
EG0030 affected12 at risk
EG0040 affected12 at risk
EG0050 affected13 at risk
EG0060 affected61 at risk
EG0070 affected20 at risk
Incarcerated hernia
General disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Covid-19 pneumonia
Infections and infestations
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected12 at risk
EG0021 affected12 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Leukocytosis
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0021 affected12 at risk
EG0030 affected12 at risk
EG0040 affected12 at risk
EG0050 affected13 at risk
EG0060 affected61 at risk
EG0070 affected20 at risk
Neutropenia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected12 at risk
EG0020 affected12 at risk
EG003
Neutrophilia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0021 affected12 at risk
EG003
Tinnitus
Ear and labyrinth disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0021 affected12 at risk
EG003
Lacrimation increased
Eye disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Photophobia
Eye disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Abdominal distension
Gastrointestinal disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected12 at risk
EG0020 affected12 at risk
EG003
Diarrhoea
Gastrointestinal disorders
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Dyspepsia
Gastrointestinal disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0021 affected12 at risk
EG003
Nausea
Gastrointestinal disorders
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected12 at risk
EG0020 affected12 at risk
EG003
Toothache
Gastrointestinal disorders
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Vomiting
Gastrointestinal disorders
Systematic Assessment
EG0000 affected12 at risk
EG0012 affected12 at risk
EG0020 affected12 at risk
EG003
Chest discomfort
General disorders
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected12 at risk
EG0020 affected12 at risk
EG003
Non-cardiac chest pain
General disorders
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected12 at risk
EG0020 affected12 at risk
EG003
Otitis media viral
Infections and infestations
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0021 affected12 at risk
EG003
Sinusitis
Infections and infestations
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Alanine aminotransferase increased
Investigations
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0021 affected12 at risk
EG003
Aspartate aminotransferase increased
Investigations
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0022 affected12 at risk
EG003
Blood creatine phosphokinase increased
Investigations
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0021 affected12 at risk
EG003
Blood glucose increased
Investigations
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Blood phosphorus decreased
Investigations
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected12 at risk
EG0020 affected12 at risk
EG003
Blood potassium increased
Investigations
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Hepatic enzyme abnormal
Investigations
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0021 affected12 at risk
EG003
Hepatic enzyme increased
Investigations
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Lipase increased
Investigations
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Lymphocyte count increased
Investigations
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Neutrophil count decreased
Investigations
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Platelet count decreased
Investigations
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected12 at risk
EG0020 affected12 at risk
EG003
Platelet count increased
Investigations
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected12 at risk
EG0020 affected12 at risk
EG003
Transaminases increased
Investigations
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected12 at risk
EG0020 affected12 at risk
EG003
White blood cell count decreased
Investigations
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected12 at risk
EG0020 affected12 at risk
EG003
White blood cell count increased
Investigations
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Haemochromatosis
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Costochondritis
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected12 at risk
EG0020 affected12 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0021 affected12 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Ageusia
Nervous system disorders
Systematic Assessment
EG0001 affected12 at risk
EG0011 affected12 at risk
EG0020 affected12 at risk
EG003
Anosmia
Nervous system disorders
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected12 at risk
EG0020 affected12 at risk
EG003
Dizziness
Nervous system disorders
Systematic Assessment
EG0003 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Dysgeusia
Nervous system disorders
Systematic Assessment
EG0001 affected12 at risk
EG0011 affected12 at risk
EG0020 affected12 at risk
EG003
Head discomfort
Nervous system disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Headache
Nervous system disorders
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected12 at risk
EG0021 affected12 at risk
EG003
Hypoaesthesia
Nervous system disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Anxiety
Psychiatric disorders
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Depression
Psychiatric disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Menstruation irregular
Reproductive system and breast disorders
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected12 at risk
EG0020 affected12 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Hypertension
Vascular disorders
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected12 at risk
EG0020 affected12 at risk
EG003
Orthostatic hypotension
Vascular disorders
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected12 at risk
EG0020 affected12 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
The study has been completed at all study sites for at least 2 years
LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.
LS Mean Difference by Day 7
-0.35
Standard Error of the Mean
0.40
2-Sided
95
-1.16
0.46
Superiority
OG003
OG005
ANCOVA
0.5248
LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate
LS Mean Difference by Day 7
-0.24
Standard Error of the Mean
0.37
2-Sided
95
-1.00
0.52
Superiority
OG004
OG005
ANCOVA
LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate
0.4610
LS Mean Difference by Day 7
-0.25
Standard Error of the Mean
0.34
2-Sided
95
-0.94
0.44
Superiority
OG006
OG007
ANCOVA
0.5006
LS Mean (SE), 95% CI and p-value were from ANCOVA with baseline viral load as a covariate.
LS Mean Difference by Day 7
0.20
Standard Error of the Mean
0.30
2-Sided
95
-0.40
0.81
Superiority
OG003
RDV, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG004
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
OG006
RDV, Part C
Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.
OG007
Placebo, Part C
Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Units
Counts
Participants
OG00011
OG00111
OG00211
OG0039
OG0049
OG00511
OG00641
OG00712
Title
Denominators
Categories
Title
Measurements
OG000-1.10± 0.856
OG001-0.55± 0.868
OG002-1.39± 1.036
OG003-1.14± 1.133
OG004-0.85± 1.164
OG005-0.70± 0.902
OG006-0.83± 1.073
OG007-0.46± 1.152
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
ANCOVA
0.3417
LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.
LS Mean Difference by Day 7
0.33
Standard Error of the Mean
0.34
2-Sided
95
-0.37
1.02
Superiority
OG001
OG002
ANCOVA
0.1803
LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.
LS Mean Difference by Day 7
0.49
Standard Error of the Mean
0.35
2-Sided
95
-0.24
1.21
Superiority
OG003
OG005
ANCOVA
0.1233
LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.
LS Mean Difference by Day 7
-0.55
Standard Error of the Mean
0.35
2-Sided
95
-1.27
0.16
Superiority
OG004
OG005
ANCOVA
0.8203
LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.
LS Mean Difference by Day 7
0.08
Standard Error of the Mean
0.35
2-Sided
95
-0.64
0.80
Superiority
OG006
OG007
ANCOVA
0.6458
LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.
LS Mean Difference by Day 7
-0.12
Standard Error of the Mean
0.26
2-Sided
95
-0.65
0.41
Superiority
RDV, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG004
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
OG006
RDV, Part C
Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.
OG007
Placebo, Part C
Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Units
Counts
Participants
OG00010
OG00110
OG0028
OG0039
OG0049
OG00512
OG00644
OG00716
Title
Denominators
Categories
Title
Measurements
OG000-0.80± 0.469
OG001-1.27± 0.877
OG002-0.49± 1.148
OG003-1.09± 1.497
OG004-0.61± 0.676
OG005-0.93± 0.678
OG006-1.25± 0.977
OG007-1.01± 1.096
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
ANCOVA
0.5951
LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.
LS Mean Difference by Day 7
-0.22
Standard Error of the Mean
0.40
2-Sided
95
-1.05
0.61
Superiority
OG001
OG002
ANCOVA
0.0872
LS Mean Difference by Day 7
-0.71
Standard Error of the Mean
0.40
2-Sided
95
-1.54
0.11
Superiority
LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.
OG003
OG005
ANCOVA
0.6031
LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.
LS Mean Difference by Day 7
-0.19
Standard Error of the Mean
0.36
2-Sided
95
-0.94
0.56
Superiority
OG004
OG005
ANCOVA
0.7578
LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.
LS Mean Difference by Day 7
0.12
Standard Error of the Mean
0.37
2-Sided
95
-0.64
0.87
Superiority
OG006
OG007
ANCOVA
0.8846
LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.
LS Mean Difference by Day 7
0.04
Standard Error of the Mean
0.26
2-Sided
95
-0.48
0.56
Superiority
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
OG003
RDV, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG004
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
OG006
RDV, Part C
Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.
OG007
Placebo, Part C
Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG00312
OG00412
OG00513
OG00661
OG00720
Title
Denominators
Categories
Title
Measurements
OG00058.3
OG00158.3
OG00241.7
OG00333.3
OG00458.3
OG00538.5
OG00642.6
OG00725.0
OG003
RDV, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG004
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
OG006
RDV, Part C
Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.
OG007
Placebo, Part C
Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Units
Counts
Participants
OG00012
OG00112
OG00211
OG00311
OG00412
OG00513
OG00661
OG00720
Title
Denominators
Categories
Title
Measurements
OG00058.3
OG00191.7
OG00263.6
OG00363.6
OG00483.3
OG00561.5
OG00668.9
OG00775.0
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
OG006
RDV, Part C
Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.
OG007
Placebo, Part C
Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG00312
OG00412
OG00513
OG00661
OG00720
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0028.3
OG0030
OG0040
OG0050
OG0061.6
OG0070
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG004
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
OG006
RDV, Part C
Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.
OG007
Placebo, Part C
Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG00312
OG00412
OG00513
OG00661
OG00720
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
OG0021
OG0030
OG0041
OG0051
OG0060
OG0070
OG004
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
OG006
RDV, Part C
Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.
OG007
Placebo, Part C
Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG00312
OG00412
OG00513
OG00661
OG00720
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0021
OG0030
OG0040
OG0051
OG0060
OG0070
OG004
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
OG006
RDV, Part C
Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.
OG007
Placebo, Part C
Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG00312
OG00412
OG00513
OG00661
OG00720
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0021
OG0030
OG0041
OG0051
OG0060
OG0070
OG002
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
OG003
RDV, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG004
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG002
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
OG003
RDV, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG004
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG002
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
OG003
RDV, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG004
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
OG003
RDV, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG004
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
OG003
RDV, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG004
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
OG003
RDV, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG004
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
OG003
RDV, Part B
Participants received inhaled RDV 62 mg administered as an aerosolized solution by inhalation through facemask daily for 5 days.
OG004
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
OG003
RDV, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG004
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
OG003
RDV, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG004
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG002
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
OG003
RDV, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG004
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG002
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
OG003
RDV, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG004
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Placebo, Part A
Participants received placebo to match inhaled RDV in Part A daily for 5 days.
OG003
RDV, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG004
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
OG006
RDV, Part C
Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.
OG007
Placebo, Part C
Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Units
Counts
Participants
OG00011
OG00111
OG00211
OG0038
OG0049
OG00512
OG00640
OG00712
Title
Denominators
Categories
Title
Measurements
OG000-2.44± 1.240
OG001-1.67± 0.992
OG002-1.78± 1.357
OG003-1.53± 1.063
OG004-1.68± 1.475
OG005-2.09± 1.052
OG006-2.01± 1.402
OG007-2.06± 1.321
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
OG006
RDV, Part C
Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.
OG007
Placebo, Part C
Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Units
Counts
Participants
OG00011
OG00110
OG00211
OG0038
OG0049
OG0059
OG00640
OG00712
Title
Denominators
Categories
Title
Measurements
OG000-1.24± 0.957
OG001-0.88± 0.839
OG002-1.26± 1.418
OG003-1.29± 1.457
OG004-1.13± 1.394
OG005-1.10± 0.988
OG006-0.92± 1.213
OG007-0.66± 1.581
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
OG006
RDV, Part C
Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.
OG007
Placebo, Part C
Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Units
Counts
Participants
OG00010
OG0018
OG0028
OG0038
OG0047
OG00510
OG00642
OG00714
Title
Denominators
Categories
Title
Measurements
OG000-0.99± 0.562
OG001-1.26± 1.288
OG002-0.77± 1.449
OG003-1.60± 1.443
OG004-0.31± 0.708
OG005-0.92± 1.040
OG006-1.36± 1.056
OG007-1.15± 0.962
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
OG006
RDV, Part C
Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.
OG007
Placebo, Part C
Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Units
Counts
Participants
OG00011
OG0019
OG00211
OG0038
OG00410
OG00510
OG00639
OG00715
Title
Denominators
Categories
Title
Measurements
OG000-3.05± 1.225
OG001-2.12± 1.051
OG002-2.09± 1.331
OG003-1.80± 1.389
OG004-2.30± 1.257
OG005-2.34± 1.873
OG006-2.64± 1.299
OG007-2.62± 1.555
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
OG006
RDV, Part C
Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.
OG007
Placebo, Part C
Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Units
Counts
Participants
OG00011
OG0019
OG00210
OG0038
OG0049
OG0059
OG00636
OG00710
Title
Denominators
Categories
Title
Measurements
OG000-1.76± 1.113
OG001-0.40± 1.049
OG002-1.98± 0.971
OG003-1.73± 1.513
OG004-1.08± 1.160
OG005-1.27± 0.845
OG006-1.07± 1.122
OG007-0.62± 1.606
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
OG006
RDV, Part C
Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.
OG007
Placebo, Part C
Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Units
Counts
Participants
OG00010
OG0018
OG0027
OG0038
OG0049
OG0058
OG00638
OG00715
Title
Denominators
Categories
Title
Measurements
OG000-1.28± 1.102
OG001-1.24± 2.108
OG002-0.62± 1.406
OG003-1.91± 1.667
OG004-0.99± 0.943
OG005-1.53± 1.553
OG006-1.69± 1.302
OG007-1.31± 1.752
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
Units
Counts
Participants
OG00011
OG00110
OG0028
OG0036
OG0049
OG00511
Title
Denominators
Categories
Title
Measurements
OG000-4.11± 1.304
OG001-2.96± 1.475
OG002-3.31± 1.198
OG003-2.82± 1.888
OG004-2.86± 1.837
OG005-3.41± 1.442
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
Units
Counts
Participants
OG00010
OG00110
OG00211
OG0036
OG0047
OG0058
Title
Denominators
Categories
Title
Measurements
OG000-2.46± 0.908
OG001-1.47± 0.841
OG002-2.36± 0.951
OG003-1.46± 1.194
OG004-1.95± 1.283
OG005-2.05± 1.092
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
Units
Counts
Participants
OG0009
OG0018
OG0026
OG0036
OG0048
OG0053
Title
Denominators
Categories
Title
Measurements
OG000-2.58± 1.413
OG001-2.27± 1.136
OG002-1.78± 0.618
OG003-2.30± 1.505
OG004-2.11± 1.171
OG005-3.53± 1.253
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG004
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
OG006
RDV, Part C
Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.
OG007
Placebo, Part C
Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Units
Counts
Participants
OG00011
OG00111
OG00211
OG0038
OG00410
OG00513
OG00646
OG00716
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Since less than 50% of participants had negative SARS-CoV-2 PCR result, the median time to negative SARS-CoV-2 PCR couldn't be calculated.
OG00117.0(16.0 to 17.0)
OG002NA(NA to NA)Since less than 50% of participants had negative SARS-CoV-2 PCR result, the median time to negative SARS-CoV-2 PCR couldn't be calculated.
OG00316.0(7.0 to 16.0)
OG004NA(NA to NA)Since less than 50% of participants had negative SARS-CoV-2 PCR result, the median time to negative SARS-CoV-2 PCR couldn't be calculated.
OG005NA(NA to NA)Since less than 50% of participants had negative SARS-CoV-2 PCR result, the median time to negative SARS-CoV-2 PCR couldn't be calculated.
OG006NA(NA to NA)Since less than 50% of participants had negative SARS-CoV-2 PCR result, the median time to negative SARS-CoV-2 PCR couldn't be calculated.
OG007NA(NA to NA)Since less than 50% of participants had negative SARS-CoV-2 PCR result, the median time to negative SARS-CoV-2 PCR couldn't be calculated.
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG004
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
OG006
RDV, Part C
Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.
OG007
Placebo, Part C
Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Units
Counts
Participants
OG00011
OG00111
OG00211
OG0039
OG0049
OG00511
OG00641
OG00712
Title
Denominators
Categories
Title
Measurements
OG00014.0(5.0 to 15.0)
OG00115.0(4.0 to 16.0)
OG00213.0(7.0 to NA)Due to smaller number of participants with an event, upper limit of 95% CI could not be calculated.
OG0035.0(2.0 to 15.0)
OG004NA(NA to NA)Since less than 50% of participants had negative SARS-CoV-2 PCR result, the median time to negative SARS-CoV-2 PCR couldn't be calculated.
OG00514.0(5.0 to 15.0)
OG006NA(NA to NA)Since less than 50% of participants had negative SARS-CoV-2 PCR result, the median time to negative SARS-CoV-2 PCR couldn't be calculated.
OG007NA(NA to NA)Since less than 50% of participants had negative SARS-CoV-2 PCR result, the median time to negative SARS-CoV-2 PCR couldn't be calculated.
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 5 days.
OG004
RDV + Placebo, Part B
Participants received inhaled RDV 62 mg administered daily as an aerosolized solution by inhalation through facemask for 3 days followed by placebo to match RDV daily for 2 days.
OG005
Placebo, Part B
Participants received placebo to match inhaled RDV in Part B daily for 5 days.
OG006
RDV, Part C
Participants received inhaled RDV 39 mg administered daily as an aerosolized solution by inhalation through mouth piece for 5 days.
OG007
Placebo, Part C
Participants received placebo to match inhaled RDV in Part C daily for 5 days.
Units
Counts
Participants
OG00011
OG00110
OG0028
OG00310
OG0049
OG00512
OG00645
OG00716
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Since less than 50% of participants had negative SARS-CoV-2 PCR result, the median time to negative SARS-CoV-2 PCR couldn't be calculated.
OG00117.0(13.0 to 17.0)
OG002NA(NA to NA)Since less than 50% of participants had negative SARS-CoV-2 PCR result, the median time to negative SARS-CoV-2 PCR couldn't be calculated.
OG00316.0(7.0 to 16.0)
OG00414.0(3.0 to 15.0)
OG005NA(NA to NA)Since less than 50% of participants had negative SARS-CoV-2 PCR result, the median time to negative SARS-CoV-2 PCR couldn't be calculated.
OG006NA(NA to NA)Since less than 50% of participants had negative SARS-CoV-2 PCR result, the median time to negative SARS-CoV-2 PCR couldn't be calculated.
OG00716.0(7.0 to 16.0)
Units
Counts
Participants
OG00039
OG0019
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Since less than 50% of participants achieved alleviation, the median time to alleviation couldn't be calculated.
OG001NA(NA to NA)Since less than 50% of participants achieved alleviation, the median time to alleviation couldn't be calculated.