The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14.
Drug: Remdesivir
Administered as an intravenous infusion
Other Name: Array
Drug: Standard of Care
Standard of Care Treatment for COVID-19 Infection
Key Inclusion Criteria:
- Willing and able to provide written informed consent, or with a legal representative
who can provide informed consent, or enrolled under International Conference on
Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the
investigator (age ≥ 18), or willing and able to provide assent (age ≥ 12 to < 18,
where locally and nationally approved) prior to performing study procedures
- Aged ≥ 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
institutional review board (IRB) or independent ethics committee (IEC))
- Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by
polymerase chain reaction (PCR) test ≤ 4 days before randomization
- Currently hospitalized
- Peripheral capillary oxygen saturation (SpO2) ≤ 94% or requiring supplemental oxygen
at screening
Key Exclusion Criteria:
- Participation in any other clinical trial of an experimental treatment for COVID-19
- Concurrent treatment with other agents with actual or possible direct acting antiviral
activity against SARS-CoV-2 is prohibited < 24 hours prior to study drug dosing
- Evidence of multiorgan failure
- Mechanically ventilated [including veno-venous (V-V) extracorporeal membrane
oxygenation (ECMO)] ≥ 5 days, or any duration of veno-arterial (V-A) ECMO.
- Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit
of normal (ULN)
- Creatinine clearance < 50 mL/min using the Cockcroft-Gault formula for participants ≥
18 years of age {Cockcroft 1976} and Schwartz Formula for participants < 18 years of
age
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Kaiser Permanente Los Angeles Medical Center, 3340 E. La Palma Avenue
Anaheim, California, United States
Alta Bates Summit Medical Center
Berkeley, California, United States
Mills-Peninsula Medical Center
Burlingame, California, United States
Eden Medical Center
Castro Valley, California, United States
Kaiser Permanente Los Angeles Medical Center, 9333 Imperial Highway
Downey, California, United States
Kaiser Permanente Los Angeles Medical Center, 9961 Sierra Ave
Fontana, California, United States
St Joseph Hospital Eureka
Fortuna, California, United States
Kaiser Permanente Los Angeles Medical Center, 25825 S. Vermont Ave.
Harbor City, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Kaiser Permanente Los Angeles Medical Center, 6041 Cadillac Ave.
Los Angeles, California, United States
Kaiser Permanente Los Angeles Medical Center, 5601 De Soto Avenue
Los Angeles, California, United States
Mission Hospital Regional Medical Center
Mission Viejo, California, United States
Kaiser Permanente Los Angeles Medical Center, 27300 Iris Avenue
Moreno Valley, California, United States
El Camino Hospital
Mountain View, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Kaiser Permanente Oakland Medical Center
Oakland, California, United States
Kaiser Permanente Los Angeles Medical Center, 2295 S. Vineyard Avenue
Ontario, California, United States
The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange
Orange, California, United States
Kaiser Permanente Los Angeles Medical Center, 13651 Willard Street
Panorama City, California, United States
Kaiser Permanente Los Angeles Medical Center, 10800 Magnolia Avenue
Riverside, California, United States
Sutter Medical Center Sacramento, One Medical Plaza
Roseville, California, United States
Sutter Medical Center Sacramento
Sacramento, California, United States
Kaiser Permanente Los Angeles Medical Center, 4647 Zion Avenue
San Diego, California, United States
Kaiser Permanente Los Angeles Medical Center, 9455 Clairemont Mesa Blvd
San Diego, California, United States
Kaiser Permanente Oakland Medical Center, 1200 El Camino Real
San Francisco, California, United States
California Pacific Medical Center-Infectious Disease Associates Medical Group
San Francisco, California, United States
Kaiser Permanente Oakland Medical Center, 2425 Geary Blvd
San Francisco, California, United States
Kaiser Permanente Oakland Medical Center, 250 Hospital Parkway, Suite 850
San Jose, California, United States
Kaiser Permanente Oakland Medical Center, 2500 Merced St
San Leandro, California, United States
Kaiser Permanente Oakland Medical Center, 700 Lawrence Expressway
Santa Clara, California, United States
Providence St. Johns Medical Center
Santa Monica, California, United States
Sutter Santa Rosa Regional Hospital
Santa Rosa, California, United States
Stanford Hospital
Stanford, California, United States
University of Colorado Denver, University of Colorado Hospital
Aurora, Colorado, United States
SCL Health St. Joseph Hospital, 1375 East 19th Ave
Denver, Colorado, United States
SCL Health St. Joseph Hospital
Denver, Colorado, United States
Rose Medical Center
Denver, Colorado, United States
SCL Health St. Joseph Hospital, 200 Exempla Circle.
Lafayette, Colorado, United States
Yale-New Haven Hospital
New Haven, Connecticut, United States
Kaiser Permanente Hawaii Moanalua Medical Center
Honolulu, Hawaii, United States
John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
IU Health Methodist Hospital
Indianapolis, Indiana, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Tulane University
New Orleans, Louisiana, United States
Maine Medical Center
Portland, Maine, United States
Holy Cross Hospital
Silver Spring, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Brigham & Women's Hospital and Harvard Medical School
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
The University of Michigan Hospitals and Health Systems
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Hennepin Healthcare
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Providence St Patrick Hospital and International Heart Institute of MT Foundation
Missoula, Montana, United States
Darmouth-Hitchhock Medical Center
Lebanon, New Hampshire, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Robert Wood Johnson University Hospital Somerset
Hillsborough, New Jersey, United States
Robert Wood Johnson University Hospital Somerset, 1 RWJ Place
New Brunswick, New Jersey, United States
Robert Wood Johnson University Hospital Somerset, 201 Lyons Avenue
Newark, New Jersey, United States
St. Joseph's University Medical Center
Paterson, New Jersey, United States
Jacobi Medical Center
Bronx, New York, United States
James J. Peters Veterans Administration Medical Center
Bronx, New York, United States
Jamaica Hospital Medical Center
Jamaica, New York, United States
Danbury Hospital
Lagrangeville, New York, United States
North Shore University Hospital
Manhasset, New York, United States
North Shore University Hospital, 270-05 76th Ave
New Hyde Park, New York, United States
Icahn School of Medicine at Mount Sinai, 350 East 17th Street
New York, New York, United States
Icahn School of Medicine at Mount Sinai, 1000 10th Avenue
New York, New York, United States
Icahn School of Medicine at Mount Sinai, 440 West 114th St.
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, United States
New York Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Kaiser Sunnyside Medical Center, 2875 NW Stucki Ave
Hillsboro, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Kaiser Sunnyside Medical Center
Portland, Oregon, United States
Hospital of the University of Pennsylvania, 51 N. 31st Street
Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
The Miriam Hospital
Providence, Rhode Island, United States
Prisma Health Richland Hospital
Columbia, South Carolina, United States
Prisma Health Richland Hospital, 701 Grove Road
Greenville, South Carolina, United States
The Liver Institute of Methodist Dallas Medical Center
Dallas, Texas, United States
UT Southwestern Medical Center Amelia Court, HIV Research Clinic
Dallas, Texas, United States
Baylor University Medical Center
Dallas, Texas, United States
UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 5201 Harry Hines Blvd.
Dallas, Texas, United States
UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 6201 Harry Hines Blvd
Dallas, Texas, United States
Baylor University Medical Center, 1400 8th Ave
Fort Worth, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Baylor University Medical Center, 2401 S. 31st St.
Temple, Texas, United States
University of Utah Health
Salt Lake City, Utah, United States
Virginia Hospital Center
Arlington, Virginia, United States
Inova Fairfax Medical Campus
Falls Church, Virginia, United States
VCU Health Medical Center
Richmond, Virginia, United States
Providence Regional Medical Center Everett
Everett, Washington, United States
Kadlec Regional Medical Center
Kennewick, Washington, United States
Providence St. Peter Hospital
Olympia, Washington, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Swedish Center for Comprehensive Care
Seattle, Washington, United States
MultiCare Deaconess Hospital
Spokane, Washington, United States
MultiCare Tacoma General Hospital
Tacoma, Washington, United States
St Joseph Medical Center
Tacoma, Washington, United States
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
CHU Pellegrin
Bordeaux, France
CHU de Montpellier-Hopital Gui de Chauliac
Montpelier Cedex 5, France
CHU de Nantes-Hotel Dieu
Nantes, France
Hopital Saint-Louis
Paris, France
Hopital Saint Antoine
Paris, France
Charite Universitatsmedizin Berlin, Campus Virchow-Klinikum, Medizinische Klinik Infektiologie Pneumologie
Berlin, Germany
Universitatsklinikum Dusseldorf, Klinik fur Gastroenterologie, Hepatologie und Infektiologie
Düsseldorf, Germany
Universitatsklinikum Hamburg-Eppendorf
Hamburg, Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, Germany
Klinikum St. Georg gGmbH Klinik fur Infektiologie, Tropenmedizin, Nephrologie und Rheumatologie
Leipzig, Germany
Klinikum rechts der Isar der TU Munchen, Klinik und Poliklinik Innere Medizin 2
Munich, Germany
Klinik für Hämatologie, Onkologie, Immunologie
München, Germany
Robert-Bosch-Krankenhaus (RBK), Klinik Schillerhohe (KSH) und Dr. Margarete Fischer-Bosch-Institut fur klinische Pharmakologie (IKP)
Stuttgart, Germany
Prince of Wales Hospital
Hong Kong, Hong Kong
Princess Margaret Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
UOC Malattie Infettive, ASST Papa Giovanni XXIII
Bergamo, Italy
ASST degli Spedali Civili di Brescia
Brescia, Italy
ASST di Cremona - Azienda Socio Sanitaria Territor
Cremona, Italy
UOC Malattie Infettive, IRCCS Ospedale San Raffaele
Milano, Italy
Dipartimento di Malattie Infettive, Malattie Infettive I- Malattie Infettive III, AssT Fatebenefratelli Sacco Ospedale Luigi Sacco
Milano, Italy
UO Malattie Infettive, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
UOC Medicina Di Laboratorio, Azienda Ospedaliera di Padova
Padova PD, Italy
Azienda Ospedaliero Universitaria di Parma
Parma, Italy
UOC Malattie Infettive I, Fondazione IRCCS Policlinio San Matteo
Pavia, Italy
Ospedale Guglielmo da Saliceto AUSL di Piacenza
Piacenza, Italy
UOC Malattie Infettive ad Alta Intensita di Cure, Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.
Roma, Italy
Clinica Universitaria Malattie Infettive, Ospedale Amedeo di Savoia
Torino, Italy
Yokohama Municipal Citizen's Hospital
Kanagawa, Japan
Nagoya City East Medical Center
Nagoya, Japan
Tokyo Metropolitan Bokutoh Hospital
Tokyo, Japan
Kyungpook National University Hospital
Daegu, Korea, Republic of
Seoul Medical Center
Seoul, Korea, Republic of
National Medical Center
Seoul, Korea, Republic of
Amsterdam University Medical Centre - Location AMC
Amsterdam, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Erasmus Medical Centre
Rotterdam, Netherlands
National University Hospital
Singapore, Singapore
Singapore General Hospital
Singapore, Singapore
National Centre for Infectious Diseases, Tan Tock Seng Hospital
Singapore, Singapore
Hospital Principe de Asturias
Alcalá De Henares, Madrid, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitari de Bellvitge
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Universitario Cruces
Bizkaia, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Regional Universitario de Málaga
Málaga, Spain
Hospital Universitario Virgen del Rocio
Sevilla, Spain
Sahlgrenska University Hospital, Ostra
Gothenburg, Sweden
SUS (Skanes University Hospital)
Malmo, Sweden
Karolinska University Hospital
Stockholm, Sweden
Hopitaux Universitaires de Genève
Genève 14, Switzerland
Ospedale Regionale di Locarno La Carità
Lugano, Switzerland
Universitätsspital Zürich
Zürich, Switzerland
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan
China Medical University Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei City, Taiwan
Imperial College Healthcare NHS Trust
London, Greater London, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
Queen Elizabeth University Hospital
Glasgow, United Kingdom
Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom
Royal Lancaster Hospital
Lancaster, United Kingdom
Liverpool University Hospital
Liverpool, United Kingdom
Northwick Park Hospital
London, United Kingdom
Royal Free London NHS Foundation Trust
London, United Kingdom
King's College Hospital NHS Trust
London, United Kingdom
University College London
London, United Kingdom
Manchester University NHS Foundation Trust
Manchester, United Kingdom
Manchester University NHS Foundation Trust
Manchester, United Kingdom
Pennine Acute Hospitals NHS Trust
Manchester, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Sheffield Teaching Hospitals
Sheffield, United Kingdom
Gilead Study Director, Study Director
Gilead Sciences