Study in Participants With Early Stage Coronavirus Disease 2019 (COVID-19) to Evaluate the Safety, Efficacy, and Pharmacokinetics of Remdesivir Administered by Inhalation

• ClinicalTrials.gov Identifier: NCT04539262
• Recruitment Status: Completed
• First Posted: September 4, 2020
• Results First Posted: March 3, 2022
• Last Update Posted: March 3, 2022
• Sponsor: Gilead Sciences
• Information provided by (Responsible Party): Gilead Sciences

Study Description

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).

Condition or disease	Intervention/treatment	Phase
COVID-19	Drug: Remdesivir (RDV); Drug: Placebo	Phase 1; Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 156 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: September 14, 2020
• Actual Primary Completion Date: February 26, 2021
• Actual Study Completion Date: March 22, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Remdesivir (RDV), Part A; Participants will receive inhaled RDV 31 mg administered daily for 5 days.	Drug: Remdesivir (RDV); Administered as an aerosolized solution; Other Name: GS-5734™
Experimental: RDV + Placebo, Part A; 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); Administered as an aerosolized solution; Other Name: GS-5734™; Drug: Placebo; Administered as an aerosolized solution
Placebo Comparator: Placebo, Part A; Participants will receive placebo to match inhaled RDV in Part A daily for 5 days.	Drug: Placebo; Administered as an aerosolized solution
Experimental: RDV, Part B; Participants will receive inhaled RDV 62 mg administered daily for up to 5 days.	Drug: Remdesivir (RDV); Administered as an aerosolized solution; Other Name: GS-5734™
Experimental: RDV + Placebo, Part B; 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); Administered as an aerosolized solution; Other Name: GS-5734™; Drug: Placebo; Administered as an aerosolized solution
Placebo Comparator: Placebo, Part B; Participants will receive placebo to match inhaled RDV in Part B daily for 5 days.	Drug: Placebo; Administered as an aerosolized solution
Experimental: RDV, Part C; Participants will receive inhaled RDV 39 mg administered daily for 5 days.	Drug: Remdesivir (RDV); Administered as an aerosolized solution; Other Name: GS-5734™
Placebo Comparator: Placebo, Part C; Participants will receive placebo to match inhaled RDV in Part C daily for 5 days.	Drug: Placebo; Administered as an aerosolized solution

Outcome Measures

Primary Outcome Measures :

1. Time-weighted Average Change From Baseline in Nasopharyngeal Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Through Day 7 [ Time Frame: Baseline, 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.
2. Time-weighted Average Change From Baseline in Oropharyngeal SARS-CoV-2 Viral Load Through Day 7 [ Time Frame: Baseline, 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.
3. Time-weighted Average Change From Baseline in Saliva SARS-CoV-2 Viral Load Through Day 7 [ Time Frame: Baseline, 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.

Secondary Outcome Measures :

1. Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) [ Time Frame: First dose date up to 5 days plus 30 days ]
   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.
2. Percentage of Participants With Treatment-Emergent Laboratory Abnormalities as Per Severity Grade [ Time Frame: First dose date up to 5 days plus 30 days ]
   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.
3. Percentage of Participants With Treatment-Emergent Adverse Events Leading to Study Treatment Discontinuation [ Time Frame: First dose date up to 5 days plus 30 days ]
4. Number of Participants With All-Cause Medically Attended Visits (MAVs) or Death by Day 28 [ Time Frame: Randomization up to 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.
5. Number of Participants With COVID-19 Related MAVs or Death by Day 28 [ Time Frame: Randomization up to 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.
6. Number of Participants With Hospitalization by Day 28 [ Time Frame: Day 1 up to Day 28 ]
   The composite of all-cause hospitalization was estimated using Kaplan-Meier methods by treatment group.
7. Pharmacokinetic (PK) Parameter: AUC0-24h of Remdesivir (RDV) and Its Metabolites (GS-441524 and GS-704277) in Parts A and B [ Time Frame: 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. ]
   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.
8. PK Parameter: AUClast of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B [ Time Frame: 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. ]
   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.
9. PK Parameter: CLss/F of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B [ Time Frame: 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. ]
   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.
10. PK Parameter: t1/2 of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B [ Time Frame: 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. ]
    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.
11. PK Parameter: Vz/F of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B [ Time Frame: 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. ]
    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.
12. PK Parameter: Cmax of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B [ Time Frame: 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. ]
    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.
13. PK Parameter: Tmax of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B [ Time Frame: 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. ]
    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.
14. PK Parameter: Clast of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B [ Time Frame: 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. ]
    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.
15. PK Parameter: Tlast of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B [ Time Frame: 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. ]
    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.
16. PK Parameter: AUCtau of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B [ Time Frame: 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. ]
    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.
17. PK Parameter: λz of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B [ Time Frame: 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. ]
    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.
18. PK Parameter: Ctau of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B [ Time Frame: 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. ]
    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.
19. Change in Nasopharyngeal SARS-CoV-2 Viral Load From Baseline to Day 5 [ Time Frame: Baseline, Day 5 ]
20. Change in Oropharyngeal SARS-CoV-2 Viral Load From Baseline to Day 5 [ Time Frame: Baseline, Day 5 ]
21. Change in Saliva SARS-CoV-2 Viral Load From Baseline to Day 5 [ Time Frame: Baseline, Day 5 ]
22. Change in Nasopharyngeal SARS-CoV-2 Viral Load From Baseline to Day 7 [ Time Frame: Baseline, Day 7 ]
23. Change in Oropharyngeal SARS-CoV-2 Viral Load From Baseline to Day 7 [ Time Frame: Baseline, Day 7 ]
24. Change in Saliva SARS-CoV-2 Viral Load From Baseline to Day 7 [ Time Frame: Baseline, Day 7 ]
25. Change in Nasopharyngeal SARS-CoV-2 Viral Load From Baseline to Day 14 in Parts A and B [ Time Frame: Baseline, Day 14 ]
26. Change in Oropharyngeal SARS-CoV-2 Viral Load From Baseline to Day 14 in Parts A and B [ Time Frame: Baseline, Day 14 ]
27. Change in Saliva SARS-CoV-2 Viral Load From Baseline to Day 14 in Parts A and B [ Time Frame: Baseline, Day 14 ]
28. Time to Negative Nasopharyngeal SARS-CoV-2 Polymerase Chain Reaction (PCR) [ Time Frame: Baseline up to Day 17 ]
    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.
29. Time to Negative Oropharyngeal SARS-CoV-2 Polymerase Chain Reaction (PCR) [ Time Frame: Baseline up to Day 17 ]
    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.
30. Time to Negative Saliva SARS-CoV-2 Polymerase Chain Reaction (PCR) [ Time Frame: Baseline up to Day 17 ]
    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.
31. Time to Alleviation (Mild or Absent) of Baseline COVID-19 Symptoms as Reported on the COVID-19 Adapted InFLUenza Patient-Reported Outcome (FLU-PRO©) Questionnaire in Part C [ Time Frame: First dose date up to Day 14 ]
    The InFLUenza Patient-Reported Outcome (FLU-PRO©) is a 32-item patient-reported outcome questionnaire that assesses the severity of symptoms of influenza and influenza-like illness across six body systems. An additional two items can be added to assess changes in taste or smell, if the instrument is used to quantify symptoms in studies of COVID-19. Each domain scores ranges from 0 (symptom-free) to 4 (very severe symptoms). Higher scores on this scale represent higher disease severity. Alleviation is defined as symptom scores as 2 or higher at baseline are scored as 0 (absent) or 1 (mild) at post-baseline, and symptoms scored as 1 at baseline are scored as 0 at post-baseline, and for two consecutive days. Time to alleviation was calculated using Kaplan-Meier estimates.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Arizona

The Institute for Liver Health

Mesa, Arizona, United States, 85210

The Institute for Liver Health

Tucson, Arizona, United States, 85712

United States, California

Franco Felizarta, MD

Bakersfield, California, United States, 93301

Aurora FDRC Inc.

Costa Mesa, California, United States, 92627

Elevated Health

Huntington Beach, California, United States, 92648

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Western Clinical Research

Placentia, California, United States, 92870

UC Davis Health/Medical Center

Sacramento, California, United States, 95817

United States, Florida

Bradenton Research Center, Inc.

Bradenton, Florida, United States, 34205

Integrity Clinical Research, LLC

Doral, Florida, United States, 33166

Holy Cross Hospital

Fort Lauderdale, Florida, United States, 33308

Evolution Clinical Trials, Inc.

Hialeah Gardens, Florida, United States, 33016

Research in Miami, Inc.

Hialeah, Florida, United States, 33013

Optimus U Corporation

Miami, Florida, United States, 33125

L & C Professional Medical Research Institute

Miami, Florida, United States, 33144

Westchester Research Center at Westchester General Hospital

Miami, Florida, United States, 33155

MedBio Trials

Miami, Florida, United States, 33180

Nuovida Research Center, Corp

Miami, Florida, United States, 33186

IMIC Inc

Palmetto Bay, Florida, United States, 33157

Triple O Research Institute, PA

West Palm Beach, Florida, United States, 33401

United States, Idaho

Family Care Research

Boise, Idaho, United States, 83704

United States, Louisiana

CTU Covid Research Center

New Orleans, Louisiana, United States, 70112

United States, Ohio

STAT Research

Vandalia, Ohio, United States, 45066

United States, Texas

Inquest Clinical Research

Baytown, Texas, United States, 77521

DFW Clinical Research

Dallas, Texas, United States, 75234

Baylor Research Institute

Dallas, Texas, United States, 75246

PCP for Life-Tidwell

Houston, Texas, United States, 77093

United States, Washington

Providence Regional Medical Center Everett

Everett, Washington, United States, 98201

Sponsors and Collaborators

Gilead Sciences

Investigators

• Study Director: Gilead Study Director; Gilead Sciences

  Study Documents (Full-Text)

Documents provided by Gilead Sciences:

Study Protocol  [PDF] January 13, 2021

Statistical Analysis Plan  [PDF] June 4, 2021

More Information

• Responsible Party: Gilead Sciences
• ClinicalTrials.gov Identifier: NCT04539262
• Other Study ID Numbers: GS-US-553-9020
• First Posted: September 4, 2020
• Results First Posted: March 3, 2022
• Last Update Posted: March 3, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Remdesivir; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antiviral Agents; Anti-Infective Agents