Official Title
Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection
Brief Summary

The primary objective of this study is to provide expanded access of remdesivir (RDV) for the treatment of severe acute respiratory syndrome coronavirus (SARS-CoV2) infection.

Approved for marketing
Treatment IND/Protocol
SARS-CoV2 Infection

Drug: Remdesivir

Intravenous infusion administered over a 30 to 120 minute period
Other Name: Array

Eligibility Criteria

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 (participants ≥ 18 years of age), or willing and able to provide assent
(participants ≥ 12 and < 18 years of age, where locally and nationally approved) prior
to performing study procedures. For participants ≥ 12 and < 18 years of age, a parent
or legal guardian willing and able to provide written informed consent prior to
performing study procedures.

- Age ≥ 18 years 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))

- Hospitalized with confirmed SARS-CoV2 by polymerase chain reaction (PCR) or known
contact of confirmed case with syndrome consistent with coronavirus disease (COVID-19)
with PCR pending

- Oxygen saturation (SpO2) ≤ 94% on room air or requiring supplemental oxygen at
baseline

- Alanine aminotransferase (ALT) < 5 x upper limit of normal (ULN) by local laboratory
measure and/or ALT < 3 x ULN and bilirubin < 2 x ULN

- Females of childbearing potential who engage in heterosexual intercourse must agree to
use protocol specified method(s) of contraception

- Lactating females must agree to discontinue nursing before the study drug is
administered and while they are participating in the study

Exclusion Criteria:

- Evidence of multiorgan failure including but not limited to coagulopathy (significant
thrombocytopenia), hepatic failure (elevated bilirubin) or renal failure (low urine
output or estimated glomerular filtration rate (eGFR) < 30 mL/min), or significant
cardiomyopathy (low cardiac output)

- Use of more than 1 pressor for septic shock (note that use of 1 pressor at low/medium
doses for inotropic support due to the use of sedation and paralytics while on the
ventilator is allowed)

- Renal failure (eGRF < 30 mL/min using the Cockcroft-Gault formula for participants ≥
18 years of age and Schwartz Formula for participants < 18 years of age) or dialysis
or continuous Veno-Venous Hemofiltration)

- Eligible for enrollment in a randomized clinical trial studying remdesivir for
treatment of SARS-CoV2 at the medical facility where the participant is admitted

- Known hypersensitivity to the study drug, the metabolites, or formulation excipient

- Requiring venous arterial (V-A) extracorporeal membrane oxygen (ECMO) (venous venous
(V-V) ECMO is not an exclusion criteria)

Eligibility Gender
All
Eligibility Age
Minimum: 12 Years ~ Maximum: N/A
Countries
Australia
Austria
Belgium
Canada
Cyprus
Czechia
Denmark
Estonia
France
Germany
Greece
Hungary
Iceland
Ireland
Israel
Italy
Lithuania
Netherlands
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Switzerland
United Kingdom
United States
Locations

University of Alabama- Birmingham
Birmingham, Alabama, United States

Banner- University Medical Center Phoenix
Phoenix, Arizona, United States

Community Regional Medical Centers (CRMC)
Fresno, California, United States

St. Jude Medical Center
Fullerton, California, United States

Scripps Memorial Hospital La Jolla
La Jolla, California, United States

Long Beach Memorial Medical Center
Long Beach, California, United States

Huntington Hospital
Pasadena, California, United States

Scripps Mercy Hospital
San Diego, California, United States

California Pacific Medical Center
San Francisco, California, United States

University of California, Medical Center (Parnassus Campus)
San Francisco, California, United States

Regional Medical Center
San Jose, California, United States

San Mateo Medical Center
San Mateo, California, United States

Santa Rosa Memorial Hospital
Santa Rosa, California, United States

Los Robles Regional Medical Center
Thousand Oaks, California, United States

PIH Health Whittier Hospital
Whittier, California, United States

The Medical Center Of Aurora
Aurora, Colorado, United States

Rose Medical Center
Denver, Colorado, United States

Swedish Medical Center
Englewood, Colorado, United States

Greenwich Hospital
Greenwich, Connecticut, United States

Middlesex Health
Middletown, Connecticut, United States

The Hospital of Central Connecticut
New Britain, Connecticut, United States

The Stamford Health Medical Group- Pulmonary Associates
Stamford, Connecticut, United States

George Washington University Hospital
Washington, District of Columbia, United States

Aventura Hospital and Medical Center
Aventura, Florida, United States

Lawnwood Regional Medical Center
Fort Pierce, Florida, United States

Memorial Regional Hospital
Hollywood, Florida, United States

Mayo Clinic in Florida
Jacksonville, Florida, United States

Mount Sinai Medical Center
Miami Beach, Florida, United States

AdventHealth Orlando, Investigational Drug Services
Orlando, Florida, United States

Sarasota Memorial Hospital
Sarasota, Florida, United States

Piedmont Atlanta Hospital
Atlanta, Georgia, United States

Wellstar Atlanta Medical Center
Atlanta, Georgia, United States

Piedmont Columbus Regional-Midtown Hospital
Columbus, Georgia, United States

Grady Health System- Grady Memorial Hospital
Decatur, Georgia, United States

Piedmont Fayette Hospital
Fayetteville, Georgia, United States

Memorial Health University Medical Center
Savannah, Georgia, United States

John D. Archbold Memorial Hospital
Thomasville, Georgia, United States

Swedish Hospital
Chicago, Illinois, United States

Mercy Hospital & Medical Center
Chicago, Illinois, United States

Northwestern Lake Forest Hospital
Lake Forest, Illinois, United States

Loyola University Medical Center
Maywood, Illinois, United States

Northwestern Medicine Central DuPage Hospital
Winfield, Illinois, United States

St. Vincent Hospital and Health Care Center, Inc.
Carmel, Indiana, United States

Richard L Roudebush Indianapolis VA
Indianapolis, Indiana, United States

Riverview Health
Noblesville, Indiana, United States

Our Lady of the Lakes Regional Medical Center
Baton Rouge, Louisiana, United States

Touro Infirmary
New Orleans, Louisiana, United States

Ochsner Clinic Foundation
New Orleans, Louisiana, United States

Slidell Memorial Hospital
Slidell, Louisiana, United States

University of Maryland
Baltimore, Maryland, United States

Mercy Medical Center
Baltimore, Maryland, United States

CalvertHealth Medical Center
Prince Frederick, Maryland, United States

University of Maryland St. Joseph Medical Center
Towson, Maryland, United States

Steward St. Elizabeth's Medical Center of Boston, Inc.
Boston, Massachusetts, United States

Cambridge Health Alliance
Cambridge, Massachusetts, United States

Charlton Memorial Hospital
Fall River, Massachusetts, United States

Lawrence General Hospital
Lawrence, Massachusetts, United States

Lowell General Hospital
Lowell, Massachusetts, United States

South Shore Hospital
South Weymouth, Massachusetts, United States

UMass Memorial Medical Center
Worcester, Massachusetts, United States

St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States

Huron Valley-Sinai Hospital
Commerce, Michigan, United States

Wayne Statue University/ Detroit Receiving Hospital
Detroit, Michigan, United States

Henry Ford Health System
Detroit, Michigan, United States

McLaren Health Care Corporation
Flint, Michigan, United States

Bronson Methodist Hospital
Kalamazoo, Michigan, United States

University of Mississippi Medical Center
Jackson, Mississippi, United States

Washington University School of Medicine
Saint Louis, Missouri, United States

CarePoint Health Bayonne Medical Center
Bayonne, New Jersey, United States

Clara Maass Medical Center
Belleville, New Jersey, United States

Cooper University Hospital
Camden, New Jersey, United States

Hackensack Meridian Health - JFK Medical Center
Edison, New Jersey, United States

Trinitas Regional Medical Center
Elizabeth, New Jersey, United States

Englewood Health
Englewood, New Jersey, United States

Hunterdon Medical Center
Flemington, New Jersey, United States

CentraState Medical Center
Freehold, New Jersey, United States

Robert Wood Johnson University Hospital Hamilton
Hamilton, New Jersey, United States

Jersey City Medical Center
Jersey City, New Jersey, United States

Christ Hospital- Carepoint Health
Jersey City, New Jersey, United States

Monmouth Medical Center
Long Branch, New Jersey, United States

Atlantic Health System/ Morristown Medical Center
Morristown, New Jersey, United States

Jersey Shore University Medical Center
Neptune, New Jersey, United States

Saint Peter's University Hospital
New Brunswick, New Jersey, United States

Saint Michael's Medical Center
Newark, New Jersey, United States

University Hospital
Newark, New Jersey, United States

Ocean Medical Center
Oakhurst, New Jersey, United States

Bayshore Medical Center
Red Bank, New Jersey, United States

The Valley Hospital
Ridgewood, New Jersey, United States

Atlantic Health System/Overlook Medical Center
Summit, New Jersey, United States

Holy Name Medical Center
Teaneck, New Jersey, United States

Capital Health
Trenton, New Jersey, United States

Virtua Health Voorhees Campus
Voorhees, New Jersey, United States

St. Peter's Hospital
Albany, New York, United States

Mount Sinai Queens
Astoria, New York, United States

Good Samaritan Hospital Medical Center
Bay Shore, New York, United States

Southside Hospital
Bay Shore, New York, United States

Lincoln Medical Center
Bronx, New York, United States

St Barnabus Hospital
Bronx, New York, United States

Montefiore Medical Center, Weiler Campus
Bronx, New York, United States

Montefiore Health System Moses Medical Center
Bronx, New York, United States

The Brooklyn Hospital Center
Brooklyn, New York, United States

Kingsbrook Jewish Medical Center
Brooklyn, New York, United States

University Hospital Brooklyn (SUNY Downstate)
Brooklyn, New York, United States

Woodhull Medical Center
Brooklyn, New York, United States

Kings County Hospital Center
Brooklyn, New York, United States

New York Harbor VA Medical Center
Brooklyn, New York, United States

Brookdale University Hospital and Medical Center
Brooklyn, New York, United States

Interfaith Medical Center
Brooklyn, New York, United States

NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States

Maimonides Medical Center
Brooklyn, New York, United States

NYU Langone Hospital - Brooklyn
Brooklyn, New York, United States

Mount Sinai Brooklyn
Brooklyn, New York, United States

New York City Health and Hospitals - Coney Island
Brooklyn, New York, United States

Kaleida Health System
Buffalo, New York, United States

Nassau University Medical Center
East Meadow, New York, United States

New York Presbyterian- Queens
Flushing, New York, United States

Glens Falls Hospital
Glens Falls, New York, United States

Queens Hospital Center
Jamaica, New York, United States

NYU Langone Health
New York, New York, United States

Hospital for Special Surgery
New York, New York, United States

New York City Health and New York City Health and Hospitals - Metropolitan- Metropolitan
New York, New York, United States

NewYork-Presyterian/Columbia University Irving Medical Center- Milstein Hospital
New York, New York, United States

New York City Health + Hospitals / Harlem
New York, New York, United States

New York Presbyterian Lower Manhattan Hospital
New York, New York, United States

Memorial Sloan-Kettering Cancer Center
New York, New York, United States

Mount Sinai South Nassau
Oceanside, New York, United States

Vassar Brothers Medical Center
Poughkeepsie, New York, United States

Rochester General Hospital
Rochester, New York, United States

St. Francis Hospital
Roslyn, New York, United States

Ellis Hospital
Schenectady, New York, United States

Staten Island University Hospital- Northwell Health (North Campus)
Staten Island, New York, United States

Stony Brook University Hospital/ Stony Brook Children's
Stony Brook, New York, United States

Samaritan Hospital
Troy, New York, United States

UNC Hospitals
Chapel Hill, North Carolina, United States

Atrium Health- Carolinas Medical Center
Charlotte, North Carolina, United States

MetroHealth Medical Center
Cleveland, Ohio, United States

The Ohio State University College of Medicine
Columbus, Ohio, United States

Kettering Medical Center
Kettering, Ohio, United States

Saint Francis Hospital
Tulsa, Oklahoma, United States

St. Luke's Hospital - Bethlehem Campus
Bethlehem, Pennsylvania, United States

Mercy Catholic Medical Center - Fitzgerald Campus
Darby, Pennsylvania, United States

St Mary Medical Center
Langhorne, Pennsylvania, United States

Philadelphia VA Medical Center
Philadelphia, Pennsylvania, United States

Einstein Medical Center Philadelphia
Philadelphia, Pennsylvania, United States

Allegheny Health Network
Pittsburgh, Pennsylvania, United States

UPMC
Pittsburgh, Pennsylvania, United States

Roger Williams Medical Center
Providence, Rhode Island, United States

Kent Hospital
Warwick, Rhode Island, United States

St. Francis Hospital
Greenville, South Carolina, United States

Lexington Medical Center
West Columbia, South Carolina, United States

TriStar Centennial Medical Center
Nashville, Tennessee, United States

St. David's South Austin Medical Center
Austin, Texas, United States

Texas Health Presbyterian Hospital Dallas
Dallas, Texas, United States

Texas Department of Criminal Justice Hospital (Hospital Galveston)/University of Texas Medical Branch
Galveston, Texas, United States

HCA Houston Healthcare West
Houston, Texas, United States

Covenant Medical Center
Lubbock, Texas, United States

Methodist Mansfield Medical Center
Mansfield, Texas, United States

Methodist Healthcare System of San Antonio, Ltd. LLP, dha, Methodist Hospital
San Antonio, Texas, United States

Saint Mark's Hospital
Salt Lake City, Utah, United States

Inova Fairfax Medical Campus
Falls Church, Virginia, United States

Henrico Doctors Hospital
Richmond, Virginia, United States

Carilion Medical Center
Roanoke, Virginia, United States

Overlake Hospital Medical Center
Bellevue, Washington, United States

University of Washington Medical Center- Montlake Campus
Seattle, Washington, United States

Medical College of Wisconsin
Milwaukee, Wisconsin, United States

St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia

Royal Brisbane and Women's Hospital
Herston, Queensland, Australia

The Alfred Hospital
Melbourne, Victoria, Australia

The Royal Melbourne Hospital
Parkville, Victoria, Australia

Gold Coast Hospital
Southport, Australia

Landeskrankenhaus Graz West
Graz, Austria

Universitätsklinik für Innere Medizin II
Innsbruck, Austria

Kepler Universitätsklinikum
Linz, Austria

Medical University and General Hospital Vienna
Vienna, Austria

Sozialmedizinisches Zentrum Süd - Kaiser-Franz-Josef-Spital
Wien, Austria

Centre Hospitalier Universitaire Saint Pierre
Brussels, Belgium

Ghent University Hospital
Ghent, Belgium

Jessa Ziekenhuis
Hasselt, Belgium

AZ Groeninge
Kortrijk, Belgium

Universitair Ziekenhuis Leuven
Leuven, Belgium

Centre Hospitalier Universitaire de Liège
Liège, Belgium

Hôpital Civil Marie Curie
Lodelinsart, Belgium

William Osler Health System
Brampton, Ontario, Canada

The Ottowa Hospital
Ottawa, Ontario, Canada

Nicosia General Hospital
Nicosia, Cyprus

Všeobecná fakultní nemocnice v Praze
Prague, Czechia

Eticka komise pro multicentircke klinicke hodnoceni Fakultni nemocnice v Motole
Praha 5, Czechia

Nemocnice Na Bulovce
Praha 8 - Liben, Czechia

Rigshospitalet
Copenhagen, Denmark

Põhja-Eesti Regionaalhaigla
Tallinn, Estonia

Vilnius University
Tartu, Estonia

Hopital Avicenne
Bobigny, France

Centre Hospitalier Regional Universitaire Brest Hôpital de la Cavale Blanche à Brest
Brest Cedex, France

Centre Hospitalier Universitaire Gabriel-Montpied
Clermont Ferrand, France

Hôpitaux Civils de Colmar
Colmar, France

Centre Hospitalier Sud Francilien
Corbeil Essonnes, France

Hôpital Raymond Poincaré
Garches, France

Centre Hospitalier Régional d'Orléans
Orléans, France

Centre Hospitalier Universitaire de Poitiers
Poitiers, France

Hôpital Charles-Nicolle
Rouen, France

Hôpital Purpan
Toulouse, France

Saint Josef Hospital Ruhr Universitaet Bochum
Bochum, Germany

Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany

Universitatsklinikum
Essen, Germany

Universitätsklinikum Freiburg
Freiburg, Germany

Universitätsmedizin Göttingen
Göttingen, Germany

Medizinische Hochschule Hannover
Hannover, Germany

Universitätsklinikum Heidelberg
Heidelberg, Germany

Universitätsklinikum des Saarlandes
Homburg, Germany

Caritas-Krankenhaus St. Josef
Regensburg, Germany

Klinikum Würzburg Mitte
Würzburg, Germany

University General Hospital of Patras Panagia I Voithia
Patra, Greece

General Hospital of Thessaloniki George Papanikolaou
Thessaloniki, Greece

Kenézy Gyula Kórház És Rendelőintézet
Debrecen, Hungary

Landspítali
Reykjavik, Iceland

Kerry University Hospital
Tralee, Ireland

Shaare Zedek Medical Center
Jerusalem, Israel

Hasharon Hospital
Petah Tikva, Israel

Sheba Medical Center at Tel Hashomer
Ramat Gan, Israel

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Ancona, Italy

Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari
Bari, Italy

Azienda Ospedaliero Universitaria
Bologna, Italy

ASST Spedali Civili di Brescia
Brescia, Italy

Presidio Ospedaliero Garibaldi-Nesima
Catania, Italy

Azienda Ospedaliero - Universitaria Careggi
Florence, Italy

Ospedale Policlinico San Martino
Genova, Italy

Ospedale Maggiore Policlinico
Milano, Italy

Ospedale San Gerardo di Monza
Monza, Italy

Azienda Ospedaliera dei Colli
Napoli, Italy

Azienda Ospedaliero-Universitaria Pisana
Pisa, Italy

IRCCS Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani
Roma, Italy

Azienda Ospedaliero Universitaria
Turin, Italy

Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, Lithuania

Vilnius University
Vilnius, Lithuania

Radboud Universitair Medisch Centrum
Nijmegen, Netherlands

HagaZiekenhuis
The Hague, Netherlands

Szpital Uniwersytecki w Krakowie
Krakow, Poland

Wojewódzki Specjalistyczny Szpital im. dr. Wł. Biegańskiego
Lodz, Poland

Wielospecjalistyczny Szpital Miejski Im Józefa Strusia Zakład Opiekuńczo Leczniczy
Poznan, Poland

Wojewódzki Szpital Specjalistyczny Megrez Sp. z o.o.
Tychy, Poland

Centro Hospitalar Universitário de Lisboa Central - Hospital Curry Cabral
Lisboa, Portugal

Centro Hospitalar Universitário do Porto E.P.E.
Porto, Portugal

Centro Hospitalar Universitário De São João
Porto, Portugal

Centro Hospitalar de Vila Nova de Gaia/Espinho
Vila Nova de Gaia, Portugal

Institutul National de Boli Infectioase Prof. Dr. Matei Bals
Bucharest, Romania

Spitalul Clinic de Boli Infecţioase Sfânta Parascheva Iaşi
Iasi, Romania

Clinical hospital for infectious disease
Timisoara, Romania

Univerzitná Nemocnica L. Pasteura Košice - Pracovisko Rastislavova 43
Košice, Slovakia

Univerzitetni Klinicni Center Ljubljana
Ljubljana, Slovenia

Univerzitetni Klinicni Center Maribor
Maribor, Slovenia

Hospital Universitari Germans Trias i Pujol
Badalona, Spain

Hospital General Universitario Gregorio Maranon
Madrid, Spain

Hospital Universitario Central de Asturias
Oviedo, Spain

Hospital Universitario Son Espases
Palma de Mallorca, Spain

Hospital Clinico Universitario de Salamanca
Salamanca, Spain

Hospital Universitario Donostia
San Sebastian, Spain

Hospital Virgen De La Salud
Santa Cruz de Tenerife, Spain

Hospital Virgen De La Salud
Toledo, Spain

Hospital Clinico Universitario de Valladolid
Valladolid, Spain

Hospital Universitario Miguel Servet
Zaragoza, Spain

Kantonsspital Aarau
Aarau, Switzerland

University Hospital Basel
Basel, Switzerland

Spitalzentrum Biel
Biel, Switzerland

Kantonsspital Graubünden
Chur, Switzerland

Centre Hospitalier Universitaire Vaudois Lausanne
Lausanne, Switzerland

Luzerner Kantonsspital
Luzern, Switzerland

Hôpital du Valais -Hôpital de Sion
Sion, Switzerland

University Hospital of Wales, Cardiff and Vale NHS Trust
Cardiff, United Kingdom

Barts Health NHS Trust
London, United Kingdom

Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom

St. George's Hospital
London, United Kingdom

Southampton University Hospital
Southampton, United Kingdom

Gilead Study Director, Study Director
Gilead Sciences

Gilead Sciences
NCT Number
MeSH Terms
Infections
Communicable Diseases
COVID-19
Remdesivir