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

Primary Purpose

COVID-19

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Remdesivir (RDV)

Placebo

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Remdesivir (RDV), Part A

RDV + Placebo, Part A

Placebo, Part A

RDV, Part B

RDV + Placebo, Part B

Placebo, Part B

RDV, Part C

Placebo, Part C

Arm Description

Participants will receive inhaled RDV 31 mg administered daily for 5 days.

Participants will receive inhaled RDV 31 mg administered daily for 3 days followed by placebo to match RDV daily for 2 days.

Participants will receive placebo to match inhaled RDV in Part A daily for 5 days.

Participants will receive inhaled RDV 62 mg administered daily for up to 5 days.

Participants will receive inhaled RDV 62 mg administered daily for up to 3 days followed by placebo to match RDV daily for 2 days.

Participants will receive placebo to match inhaled RDV in Part B daily for 5 days.

Participants will receive inhaled RDV 39 mg administered daily for 5 days.

Participants will receive placebo to match inhaled RDV in Part C daily for 5 days.

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

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.

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.

Percentage of Participants With Treatment-Emergent Adverse Events Leading to Study Treatment Discontinuation

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.

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.

Number of Participants With Hospitalization by Day 28

The composite of all-cause hospitalization was estimated using Kaplan-Meier methods by treatment group.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Change in Nasopharyngeal SARS-CoV-2 Viral Load From Baseline to Day 5

Change in Oropharyngeal SARS-CoV-2 Viral Load From Baseline to Day 5

Change in Saliva SARS-CoV-2 Viral Load From Baseline to Day 5

Change in Nasopharyngeal SARS-CoV-2 Viral Load From Baseline to Day 7

Change in Oropharyngeal SARS-CoV-2 Viral Load From Baseline to Day 7

Change in Saliva SARS-CoV-2 Viral Load From Baseline to Day 7

Change in Nasopharyngeal SARS-CoV-2 Viral Load From Baseline to Day 14 in Parts A and B

Change in Oropharyngeal SARS-CoV-2 Viral Load From Baseline to Day 14 in Parts A and B

Change in Saliva SARS-CoV-2 Viral Load From Baseline to Day 14 in Parts A and B

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.

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.

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.

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

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.

Full Information

NCT ID

NCT04539262

First Posted

August 26, 2020

Last Updated

February 18, 2022

Sponsor

Gilead Sciences

1. Study Identification

Unique Protocol Identification Number

NCT04539262

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

September 14, 2020 (Actual)

Primary Completion Date

February 26, 2021 (Actual)

Study Completion Date

March 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

156 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Remdesivir (RDV), Part A

Arm Type

Experimental

Arm Description

Participants will receive inhaled RDV 31 mg administered daily for 5 days.

Arm Title

RDV + Placebo, Part A

Arm Type

Experimental

Arm Description

Participants will receive inhaled RDV 31 mg administered daily for 3 days followed by placebo to match RDV daily for 2 days.

Arm Title

Placebo, Part A

Arm Type

Placebo Comparator

Arm Description

Participants will receive placebo to match inhaled RDV in Part A daily for 5 days.

Arm Title

RDV, Part B

Arm Type

Experimental

Arm Description

Participants will receive inhaled RDV 62 mg administered daily for up to 5 days.

Arm Title

RDV + Placebo, Part B

Arm Type

Experimental

Arm Description

Participants will receive inhaled RDV 62 mg administered daily for up to 3 days followed by placebo to match RDV daily for 2 days.

Arm Title

Placebo, Part B

Arm Type

Placebo Comparator

Arm Description

Participants will receive placebo to match inhaled RDV in Part B daily for 5 days.

Arm Title

RDV, Part C

Arm Type

Experimental

Arm Description

Participants will receive inhaled RDV 39 mg administered daily for 5 days.

Arm Title

Placebo, Part C

Arm Type

Placebo Comparator

Arm Description

Participants will receive placebo to match inhaled RDV in Part C daily for 5 days.

Intervention Type

Drug

Intervention Name(s)

Remdesivir (RDV)

Other Intervention Name(s)

GS-5734™

Intervention Description

Administered as an aerosolized solution

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered as an aerosolized solution

Primary Outcome Measure Information:

Title

Time-weighted Average Change From Baseline in Nasopharyngeal Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Through Day 7

Description

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.

Time Frame

Baseline, Day 7

Title

Time-weighted Average Change From Baseline in Oropharyngeal SARS-CoV-2 Viral Load Through Day 7

Description

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.

Time Frame

Baseline, Day 7

Title

Time-weighted Average Change From Baseline in Saliva SARS-CoV-2 Viral Load Through Day 7

Description

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.

Time Frame

Baseline, Day 7

Secondary Outcome Measure Information:

Title

Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)

Description

Time Frame

First dose date up to 5 days plus 30 days

Title

Percentage of Participants With Treatment-Emergent Laboratory Abnormalities as Per Severity Grade

Description

Time Frame

First dose date up to 5 days plus 30 days

Title

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

Title

Number of Participants With All-Cause Medically Attended Visits (MAVs) or Death by Day 28

Description

Time Frame

Randomization up to Day 28

Title

Number of Participants With COVID-19 Related MAVs or Death by Day 28

Description

Time Frame

Randomization up to Day 28

Title

Number of Participants With Hospitalization by Day 28

Description

The composite of all-cause hospitalization was estimated using Kaplan-Meier methods by treatment group.

Time Frame

Day 1 up to Day 28

Title

Pharmacokinetic (PK) Parameter: AUC0-24h of Remdesivir (RDV) and Its Metabolites (GS-441524 and GS-704277) in Parts A and B

Description

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.

Title

PK Parameter: AUClast of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B

Description

Time Frame

Title

PK Parameter: CLss/F of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B

Description

Time Frame

Title

PK Parameter: t1/2 of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B

Description

Time Frame

Title

PK Parameter: Vz/F of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B

Description

Time Frame

Title

PK Parameter: Cmax of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B

Description

Time Frame

Title

PK Parameter: Tmax of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B

Description

Time Frame

Title

PK Parameter: Clast of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B

Description

Time Frame

Title

PK Parameter: Tlast of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B

Description

Time Frame

Title

PK Parameter: AUCtau of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B

Description

Time Frame

Title

PK Parameter: λz of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B

Description

Time Frame

Title

PK Parameter: Ctau of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B

Description

Time Frame

Title

Change in Nasopharyngeal SARS-CoV-2 Viral Load From Baseline to Day 5

Time Frame

Baseline, Day 5

Title

Change in Oropharyngeal SARS-CoV-2 Viral Load From Baseline to Day 5

Time Frame

Baseline, Day 5

Title

Change in Saliva SARS-CoV-2 Viral Load From Baseline to Day 5

Time Frame

Baseline, Day 5

Title

Change in Nasopharyngeal SARS-CoV-2 Viral Load From Baseline to Day 7

Time Frame

Baseline, Day 7

Title

Change in Oropharyngeal SARS-CoV-2 Viral Load From Baseline to Day 7

Time Frame

Baseline, Day 7

Title

Change in Saliva SARS-CoV-2 Viral Load From Baseline to Day 7

Time Frame

Baseline, Day 7

Title

Change in Nasopharyngeal SARS-CoV-2 Viral Load From Baseline to Day 14 in Parts A and B

Time Frame

Baseline, Day 14

Title

Change in Oropharyngeal SARS-CoV-2 Viral Load From Baseline to Day 14 in Parts A and B

Time Frame

Baseline, Day 14

Title

Change in Saliva SARS-CoV-2 Viral Load From Baseline to Day 14 in Parts A and B

Time Frame

Baseline, Day 14

Title

Time to Negative Nasopharyngeal SARS-CoV-2 Polymerase Chain Reaction (PCR)

Description

Time Frame

Baseline up to Day 17

Title

Time to Negative Oropharyngeal SARS-CoV-2 Polymerase Chain Reaction (PCR)

Description

Time Frame

Baseline up to Day 17

Title

Time to Negative Saliva SARS-CoV-2 Polymerase Chain Reaction (PCR)

Description

Time Frame

Baseline up to Day 17

Title

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

Description

Time Frame

First dose date up to Day 14

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gilead Study Director

Organizational Affiliation

Gilead Sciences

Official's Role

Study Director

Facility Information:

Facility Name

The Institute for Liver Health

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85210

Country

United States

Facility Name

The Institute for Liver Health

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85712

Country

United States

Facility Name

Franco Felizarta, MD

City

Bakersfield

State/Province

California

ZIP/Postal Code

93301

Country

United States

Facility Name

Aurora FDRC Inc.

City

Costa Mesa

State/Province

California

ZIP/Postal Code

92627

Country

United States

Facility Name

Elevated Health

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92648

Country

United States

Facility Name

Cedars-Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Western Clinical Research

City

Placentia

State/Province

California

ZIP/Postal Code

92870

Country

United States

Facility Name

UC Davis Health/Medical Center

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

Bradenton Research Center, Inc.

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34205

Country

United States

Facility Name

Integrity Clinical Research, LLC

City

Doral

State/Province

Florida

ZIP/Postal Code

33166

Country

United States

Facility Name

Holy Cross Hospital

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33308

Country

United States

Facility Name

Evolution Clinical Trials, Inc.

City

Hialeah Gardens

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Facility Name

Research in Miami, Inc.

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33013

Country

United States

Facility Name

Optimus U Corporation

City

Miami

State/Province

Florida

ZIP/Postal Code

33125

Country

United States

Facility Name

L & C Professional Medical Research Institute

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Westchester Research Center at Westchester General Hospital

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Facility Name

MedBio Trials

City

Miami

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

Nuovida Research Center, Corp

City

Miami

State/Province

Florida

ZIP/Postal Code

33186

Country

United States

Facility Name

IMIC Inc

City

Palmetto Bay

State/Province

Florida

ZIP/Postal Code

33157

Country

United States

Facility Name

Triple O Research Institute, PA

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Facility Name

Family Care Research

City

Boise

State/Province

Idaho

ZIP/Postal Code

83704

Country

United States

Facility Name

CTU Covid Research Center

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

Facility Name

STAT Research

City

Vandalia

State/Province

Ohio

ZIP/Postal Code

45066

Country

United States

Facility Name

Inquest Clinical Research

City

Baytown

State/Province

Texas

ZIP/Postal Code

77521

Country

United States

Facility Name

DFW Clinical Research

City

Dallas

State/Province

Texas

ZIP/Postal Code

75234

Country

United States

Facility Name

Baylor Research Institute

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

PCP for Life-Tidwell

City

Houston

State/Province

Texas

ZIP/Postal Code

77093

Country

United States

Facility Name

Providence Regional Medical Center Everett

City

Everett

State/Province

Washington

ZIP/Postal Code

98201

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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

COVID-19

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial