COVID-19Phase 1/2NCT04539262
Study in Participants With Early Stage Coronavirus Disease 2019 (COVID-19) to Evaluate the Safety, Efficacy, and Pharmacokinetics of Remdesivir Administered by Inhalation
A Phase 1/2 study testing Remdesivir (RDV) in people with COVID-19, run by Gilead Sciences at 28 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Remdesivir (RDV)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 28 sitesUnited States
- Study dates
- 14 Sep 2020to 22 Mar 2021
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Franco Felizarta, MD
Bakersfield, California, 93301
Inquest Clinical Research
Baytown, Texas, 77521
Family Care Research
Boise, Idaho, 83704
Bradenton Research Center, Inc.
Bradenton, Florida, 34205
Aurora FDRC Inc.
Costa Mesa, California, 92627
DFW Clinical Research
Dallas, Texas, 75234
Baylor Research Institute
Dallas, Texas, 75246
Integrity Clinical Research, LLC
Doral, Florida, 33166
Providence Regional Medical Center Everett
Everett, Washington, 98201
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Research in Miami, Inc.
Hialeah, Florida, 33013
Evolution Clinical Trials, Inc.
Hialeah Gardens, Florida, 33016
PCP for Life-Tidwell
Houston, Texas, 77093
Elevated Health
Huntington Beach, California, 92648
Cedars-Sinai Medical Center
Los Angeles, California, 90048
The Institute for Liver Health
Mesa, Arizona, 85210
Optimus U Corporation
Miami, Florida, 33125
L & C Professional Medical Research Institute
Miami, Florida, 33144
Westchester Research Center at Westchester General Hospital
Miami, Florida, 33155
MedBio Trials
Miami, Florida, 33180
Nuovida Research Center, Corp
Miami, Florida, 33186
CTU Covid Research Center
New Orleans, Louisiana, 70112
IMIC Inc
Palmetto Bay, Florida, 33157
Western Clinical Research
Placentia, California, 92870
UC Davis Health/Medical Center
Sacramento, California, 95817
The Institute for Liver Health
Tucson, Arizona, 85712
STAT Research
Vandalia, Ohio, 45066
Triple O Research Institute, PA
West Palm Beach, Florida, 33401
About this study
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
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).
Read the 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
- COVID-19
- Being tested
- Remdesivir (RDV), Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remdesivir (RDV)Drug
Also called GS-5734™
Administered as an aerosolized solution
PlaceboDrug
Administered as an aerosolized solution
| Study group | Role | What they receive |
|---|---|---|
| Remdesivir (RDV), Part A | Experimental | Participants will receive inhaled RDV 31 mg administered daily for 5 days. Receives: 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. Receives: 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. Receives: Drug: Placebo |
| RDV, Part B | Experimental | Participants will receive inhaled RDV 62 mg administered daily for up to 5 days. Receives: 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. Receives: Drug: Remdesivir (RDV); Drug: Placebo |
| Placebo, Part B | Placebo comparator | Participants will receive placebo to match inhaled RDV in Part B daily for 5 days. Receives: Drug: Placebo |
| RDV, Part C | Experimental | Participants will receive inhaled RDV 39 mg administered daily for 5 days. Receives: Drug: Remdesivir (RDV) |
| Placebo, Part C | Placebo comparator | Participants will receive placebo to match inhaled RDV in Part C daily for 5 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, Day 7
Secondary outcomes (31)
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.
Measured: 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.
Measured: First dose date up to 5 days plus 30 days
Percentage of Participants With Treatment-Emergent Adverse Events Leading to Study Treatment Discontinuation
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline, Day 5
Change in Oropharyngeal SARS-CoV-2 Viral Load From Baseline to Day 5
Measured: Baseline, Day 5
Change in Saliva SARS-CoV-2 Viral Load From Baseline to Day 5
Measured: Baseline, Day 5
Change in Nasopharyngeal SARS-CoV-2 Viral Load From Baseline to Day 7
Measured: Baseline, Day 7
Change in Oropharyngeal SARS-CoV-2 Viral Load From Baseline to Day 7
Measured: Baseline, Day 7
Change in Saliva SARS-CoV-2 Viral Load From Baseline to Day 7
Measured: Baseline, Day 7
Change in Nasopharyngeal SARS-CoV-2 Viral Load From Baseline to Day 14 in Parts A and B
Measured: Baseline, Day 14
Change in Oropharyngeal SARS-CoV-2 Viral Load From Baseline to Day 14 in Parts A and B
Measured: Baseline, Day 14
Change in Saliva SARS-CoV-2 Viral Load From Baseline to Day 14 in Parts A and B
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline up to Day 17
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.
Measured: First dose date up to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start14 Sep 2020
- Primary completion26 Feb 2021
- Study completion22 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539262
- Sponsor's protocol ID
- GS-US-553-9020
- Status last verified
- Feb 2022
- First submitted
- 26 Aug 2020
- Last updated
- 3 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04539262
- Acronym / sponsor ID
- GS-US-553-9020
- Conditions
- COVID-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 22 Mar 2021 (actual)
- First posted
- 4 Sep 2020 (actual)
- Results
- Posted 3 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Remdesivir (RDV), Part A | Experimental | Drug: Remdesivir (RDV)Participants will receive inhaled RDV 31 mg administered daily for 5 days. |
| RDV + Placebo, Part A | Experimental | Drug: Remdesivir (RDV), Drug: PlaceboParticipants will receive inhaled RDV 31 mg administered daily for 3 days followed by placebo to match RDV daily for 2 days. |
| Placebo, Part A | Placebo comparator | Drug: PlaceboParticipants will receive placebo to match inhaled RDV in Part A daily for 5 days. |
| RDV, Part B | Experimental | Drug: Remdesivir (RDV)Participants will receive inhaled RDV 62 mg administered daily for up to 5 days. |
| RDV + Placebo, Part B | Experimental | Drug: Remdesivir (RDV), Drug: PlaceboParticipants will receive inhaled RDV 62 mg administered daily for up to 3 days followed by placebo to match RDV daily for 2 days. |
| Placebo, Part B | Placebo comparator | Drug: PlaceboParticipants will receive placebo to match inhaled RDV in Part B daily for 5 days. |
| RDV, Part C | Experimental | Drug: Remdesivir (RDV)Participants will receive inhaled RDV 39 mg administered daily for 5 days. |
| Placebo, Part C | Placebo comparator | Drug: PlaceboParticipants will receive placebo to match inhaled RDV in Part C daily for 5 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (10 listed)
- 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
- Requiring oxygen supplementation
- Positive pregnancy test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remdesivir (RDV)Also: GS-5734™Administered as an aerosolized solution | Drug | RDV + Placebo, Part A, RDV + Placebo, Part B, RDV, Part B, RDV, Part C, Remdesivir (RDV), Part A |
| PlaceboAdministered as an aerosolized solution | Drug | Placebo, Part A, Placebo, Part B, Placebo, Part C, RDV + Placebo, Part A, RDV + Placebo, Part B |
Primary outcome
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.
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.
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.
31 secondary outcomes
Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
Time frame: First dose date up to 5 days plus 30 days
Percentage of Participants With Treatment-Emergent Laboratory Abnormalities as Per Severity Grade
Time frame: First dose date up to 5 days plus 30 days
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
Number of Participants With All-Cause Medically Attended Visits (MAVs) or Death by Day 28
Time frame: Randomization up to Day 28
Number of Participants With COVID-19 Related MAVs or Death by Day 28
Time frame: Randomization up to Day 28
Number of Participants With Hospitalization by Day 28
Time frame: 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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Change in Nasopharyngeal SARS-CoV-2 Viral Load From Baseline to Day 5
Time frame: Baseline, Day 5
Change in Oropharyngeal SARS-CoV-2 Viral Load From Baseline to Day 5
Time frame: Baseline, Day 5
Change in Saliva SARS-CoV-2 Viral Load From Baseline to Day 5
Time frame: Baseline, Day 5
Change in Nasopharyngeal SARS-CoV-2 Viral Load From Baseline to Day 7
Time frame: Baseline, Day 7
Change in Oropharyngeal SARS-CoV-2 Viral Load From Baseline to Day 7
Time frame: Baseline, Day 7
Change in Saliva SARS-CoV-2 Viral Load From Baseline to Day 7
Time frame: Baseline, Day 7
Change in Nasopharyngeal SARS-CoV-2 Viral Load From Baseline to Day 14 in Parts A and B
Time frame: Baseline, Day 14
Change in Oropharyngeal SARS-CoV-2 Viral Load From Baseline to Day 14 in Parts A and B
Time frame: Baseline, Day 14
Change in Saliva SARS-CoV-2 Viral Load From Baseline to Day 14 in Parts A and B
Time frame: Baseline, Day 14
Time to Negative Nasopharyngeal SARS-CoV-2 Polymerase Chain Reaction (PCR)
Time frame: Baseline up to Day 17
Time to Negative Oropharyngeal SARS-CoV-2 Polymerase Chain Reaction (PCR)
Time frame: Baseline up to Day 17
Time to Negative Saliva SARS-CoV-2 Polymerase Chain Reaction (PCR)
Time frame: Baseline up to Day 17
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Remdesivir (RDV) in people with COVID-19, run by Gilead Sciences at 28 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.