Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection (COVID-19)
NCT ID: NCT04323761
Last Updated: 2020-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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APPROVED_FOR_MARKETING
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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Conditions
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Interventions
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Remdesivir
Intravenous infusion administered over a 30 to 120 minute period
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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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
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 D.C., District of Columbia, United States
Aventura Hospital and Medical Center
Aventura, Florida, United States
Lawnwood Regional Medical Center
Ft. 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
St 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 City, 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 Township, 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
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
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
Lincoln Medical Center
The Bronx, New York, United States
St Barnabus Hospital
The Bronx, New York, United States
Montefiore Medical Center, Weiler Campus
The Bronx, New York, United States
Montefiore Health System Moses Medical Center
The Bronx, 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
Sozialmedizinisches Zentrum Süd - Kaiser-Franz-Josef-Spital
Vienna, , Austria
Medical University and General Hospital Vienna
Vienna, , 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
Prague, , 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, , 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 im Breisgau, , Germany
Universitätsmedizin Göttingen
Göttingen, , Germany
Medizinische Hochschule Hannover
Hanover, , 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
Pátrai, , 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
Milan, , 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
Lisbon, , 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
Iași, , Romania
Clinical hospital for infectious disease
Timișoara, , 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 Universitario Donostia
Donostia / San Sebastian, , 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 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
Lucerne, , 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
Countries
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Other Identifiers
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2020-001453-49
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-540-5821
Identifier Type: -
Identifier Source: org_study_id