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).
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.
Drug: Remdesivir (RDV)
Administered as an aerosolized solution
Other Name: GS-5734™
Drug: Placebo
Administered as an aerosolized solution
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.
The Institute for Liver Health
Mesa, Arizona, United States
The Institute for Liver Health
Tucson, Arizona, United States
Franco Felizarta, MD
Bakersfield, California, United States
Aurora FDRC Inc.
Costa Mesa, California, United States
Elevated Health
Huntington Beach, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Western Clinical Research
Placentia, California, United States
UC Davis Health/Medical Center
Sacramento, California, United States
Bradenton Research Center, Inc.
Bradenton, Florida, United States
Integrity Clinical Research, LLC
Doral, Florida, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Evolution Clinical Trials, Inc.
Hialeah Gardens, Florida, United States
Research in Miami, Inc.
Hialeah, Florida, United States
Optimus U Corporation
Miami, Florida, United States
L & C Professional Medical Research Institute
Miami, Florida, United States
Westchester Research Center at Westchester General Hospital
Miami, Florida, United States
MedBio Trials
Miami, Florida, United States
Nuovida Research Center, Corp
Miami, Florida, United States
IMIC Inc
Palmetto Bay, Florida, United States
Triple O Research Institute, PA
West Palm Beach, Florida, United States
Family Care Research
Boise, Idaho, United States
CTU Covid Research Center
New Orleans, Louisiana, United States
STAT Research
Vandalia, Ohio, United States
Inquest Clinical Research
Baytown, Texas, United States
DFW Clinical Research
Dallas, Texas, United States
Baylor Research Institute
Dallas, Texas, United States
PCP for Life-Tidwell
Houston, Texas, United States
Providence Regional Medical Center Everett
Everett, Washington, United States
Gilead Study Director, Study Director
Gilead Sciences