The primary objectives of this study are to evaluate the efficacy of remdesivir (RDV) in reducing the rate of of coronavirus disease 2019 (COVID-19) related hospitalization or all-cause death in non-hospitalized participants with early stage COVID-19 and to evaluate the safety of RDV administered in an outpatient setting.
Drug: RDV
Administered as an intravenous infusion
Other Name: Array
Drug: Placebo to Match RDV
Administered as an intravenous infusion
Key Inclusion Criteria:
- Willing and able to provide written informed consent, (individuals ≥ 18 years of age)
or assent (individuals ≥ 12 and < 18 years of age) prior to performing study
procedures. Individuals age ≥ 18 years may be enrolled with the consent of a legal
representative where permitted according to local law and approved nationally and by
the relevant institutional review board (IRB) or independent ethics committee (IEC).
For individuals ≥ 12 and < 18 years of age, a parent or legal guardian must be willing
and able to provide written informed consent prior to performing study procedures
- Either:
- Age ≥ 18 years (at all sites) or aged ≥ 12 and < 18 years of age weighing ≥ 40 kg
(where permitted according to local law and approved nationally and by the
relevant IRB or IEC with at least 1 pre-existing risk factor for progression to
hospitalization (chronic lung disease, hypertension, cardiovascular or
cerebrovascular disease, diabetes, obesity (body mass index ≥ 30),
immunocompromised, chronic mild or moderate kidney disease, chronic liver
disease, current cancer, or sickle cell disease)
- Or aged ≥ 60 years
- Severe acute respiratory syndrome (SARS)-coronavirus (CoV)-2 infection confirmed by
molecular diagnosis (nucleic acid (polymerase chain reaction (PCR) or antigen testing)
≤ 4 days prior to screening
- Presence of ≥ 1 symptom(s) consistent with COVID-19 for ≤ 7 days prior to
randomization
- Not currently requiring hospitalization (hospitalization defined as ≥ 24 hours of
acute care)
Key Exclusion Criteria:
- Participation in any other clinical trial of an experimental treatment and prevention
for COVID-19
- Prior hospitalization for COVID-19
- Treatment with other agents with actual or possible direct antiviral activity against
SARS-CoV-2 or administration of any SARS-CoV-2 (or COVID-19) vaccine
- Requiring oxygen supplementation
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Arizona Liver Health
Chandler, Arizona, United States
Arizona Clinical Trials
Tucson, Arizona, United States
St Joseph Hospital Eureka
Eureka, California, United States
St. Joseph Heritage Healthcare
Fullerton, California, United States
Elevated Health
Huntington Beach, California, United States
Ruane Clinical Research Group
Los Angeles, California, United States
LA Universal Center, INC.
Los Angeles, California, United States
Mills Clinical Research
Los Angeles, California, United States
Kaiser Permanente Northern California
Oakland, California, United States
FOMAT Medical Research
Oxnard, California, United States
UC Davis Health
Sacramento, California, United States
Kaiser Permanente Northern California, 6600 Bruceville Road
Sacramento, California, United States
Kaiser Permanente Northern California, 2025 Morse Ave
Sacramento, California, United States
Kaiser Permanente Northern California, 1200 El Camino Real
San Francisco, California, United States
Kaiser Permanente Northern California, 2425 Geary Blvd
San Francisco, California, United States
UCSF Medical Center
San Francisco, California, United States
Kaiser Permanente Northern California, 250 Hospital Parkway, Suite 850
San Jose, California, United States
Kaiser Permanente Northern California, 2500 Merced St
San Leandro, California, United States
St. Joseph Heritage Healthcare
Santa Rosa, California, United States
Premiere Medical Center of Burbank, Inc
Toluca Lake, California, United States
Kaiser Permanente Northern California, 975 Sereno Drive
Vallejo, California, United States
New Hope Research Development DBA HCD
Whittier, California, United States
Centura Health Porter Place
Denver, Colorado, United States
Nuvance Health
Danbury, Connecticut, United States
RecioMed Clinical Research Network
Boynton Beach, Florida, United States
Midland Florida Clinical Research Center, LLC
DeLand, Florida, United States
Invesclinic
Fort Lauderdale, Florida, United States
Lawnwood Regional Medical Center
Fort Pierce, Florida, United States
Evolution Clinical Trials
Hialeah Gardens, Florida, United States
Encore Medical Research
Hollywood, Florida, United States
Advanced Pulmonary Research Institute
Loxahatchee Groves, Florida, United States
L&C Professional Medical Research Institute
Miami, Florida, United States
Laguna Clinical Research Associates
Miami, Florida, United States
CTMD Research, Inc
Palm Springs, Florida, United States
IMIC Inc
Palmetto Bay, Florida, United States
Luminous Clinical Research - South Florida Urgent Care
Pembroke Pines, Florida, United States
St. Josephs Comprehensive Research Institute
Tampa, Florida, United States
AIDS Research and Treatment Center of the Treasure Coast
Vero Beach, Florida, United States
Triple O Research Institute PA
West Palm Beach, Florida, United States
Agile Clinical Research Trials
Atlanta, Georgia, United States
Mercer University School of Medicine
Macon, Georgia, United States
Infectious Disease Associates of Kansas City, P.C.Infectious Disease Associates of Kansas City, P.C.
Burr Ridge, Illinois, United States
Metro Infectious Disease Consultants
Burr Ridge, Illinois, United States
NorthStar Medical Center
Chicago, Illinois, United States
NorthShore University Healthsystem
Evanston, Illinois, United States
Tulane University
New Orleans, Louisiana, United States
Holy Cross Hospital, Inc.
Baltimore, Maryland, United States
University of Maryland Baltimore
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
South Shore Hospital
South Weymouth, Massachusetts, United States
VA Boston Healthcare System
West Roxbury, Massachusetts, United States
Be Well Medical Center
Berkley, Michigan, United States
Onyx Research Institute
Flint, Michigan, United States
Memorial Hospital of Gulfport
Gulfport, Mississippi, United States
Metro Infectious Disease Consultants
Kansas City, Missouri, United States
Quality Clinical Research Inc.
Omaha, Nebraska, United States
AB Clinical Trials
Las Vegas, Nevada, United States
AXCES Research Group
Santa Fe, New Mexico, United States
New York Presbyterian Hospital
Flushing, New York, United States
Northwell Health
New Hyde Park, New York, United States
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Rosedale Infectious Diseases
Huntersville, North Carolina, United States
Christ Hospital
Cincinnati, Ohio, United States
Cherokee Nation WW Hastings Hospital
Tahlequah, Oklahoma, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Temple University
Philadelphia, Pennsylvania, United States
Avera Research Institute
Sioux Falls, South Dakota, United States
University of Tennessee Health Science Center
Knoxville, Tennessee, United States
Central Texas Clinical Research
Austin, Texas, United States
UT Physicians
Bellaire, Texas, United States
Baylor University Medical Center, 700 Scott and White Dr.
College Station, Texas, United States
Baylor University Medical Center
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Care United Research, LLC
Forney, Texas, United States
VIP Trials
Harlingen, Texas, United States
University of Texas
Houston, Texas, United States
The Crofoot Research Center, Inc
Houston, Texas, United States
Baylor University Medical Center, 1901 North McArthur Blvd
Irving, Texas, United States
Laguna Clinical Research Associates
Laredo, Texas, United States
Diagnostic Clinic of Longview - Center for Clinical Research
Longview, Texas, United States
STAAMP Research
San Antonio, Texas, United States
Sugar Lakes Family Practice
Sugar Land, Texas, United States
Baylor University Medical Center, 2201 MacArthur Dr., Suite 100
Waco, Texas, United States
ClinPoint Trials
Waxahachie, Texas, United States
Intermountain Healthcare
Murray, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Providence Regional Medical Center Everett
Everett, Washington, United States
Sound Medical Research
Port Orchard, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Providence Medical Research Center
Spokane, Washington, United States
Wisconsin Corporation for Biomedical Research
Milwaukee, Wisconsin, United States
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus N, Denmark
Rigshospitalet
Copenhagen, Denmark
Hvidovre Hospital
Hvidovre, Denmark
Odense University Hospital
Odense, Denmark
Hospital Universitari Germans Trias i Pujol
Badalona, Spain
Hospital Clinic
Barcelona, Spain
Hospital Universitario Infanta Leonor
Madrid, Spain
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, United Kingdom
University College Hospital
London, United Kingdom
St Mary's Hospital
London, United Kingdom
Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle Upon Tyne, United Kingdom
Gilead Study Director, Study Director
Gilead Sciences