Official Title
A Phase 3 Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of COVID-19 in an Outpatient Setting
Brief Summary

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.

Terminated
COVID-19

Drug: RDV

Administered as an intravenous infusion
Other Name: Array

Drug: Placebo to Match RDV

Administered as an intravenous infusion

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 12 Years ~ Maximum: N/A
Countries
Denmark
Spain
United Kingdom
United States
Locations

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

Gilead Sciences
NCT Number
MeSH Terms
COVID-19
Remdesivir