Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection (COVID-19)

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

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.

Study Overview

• Status: Approved for marketing
• Conditions: SARS-CoV2 Infection
• Intervention / Treatment: Drug: Remdesivir

• Study Type: Expanded Access
• Expanded Access Type: Treatment IND/Protocol

Contacts and Locations

Study Locations

• Australia
  • Southport, Australia, 4215
    • Gold Coast Hospital
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • St. Vincent's Hospital Sydney
  • Queensland
    • Herston, Queensland, Australia, 4029
      • Royal Brisbane and Women's Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
    • Parkville, Victoria, Australia, 3050
      • The Royal Melbourne Hospital
• Austria
  • Graz, Austria, 8020
    • Landeskrankenhaus Graz West
  • Innsbruck, Austria, 06020
    • Universitätsklinik für Innere Medizin II
  • Linz, Austria, A-4020
    • Kepler Universitätsklinikum
  • Vienna, Austria
    • Medical University and General Hospital Vienna
  • Wien, Austria, 1100
    • Sozialmedizinisches Zentrum Süd - Kaiser-Franz-Josef-Spital
• Belgium
  • Brussels, Belgium, 1000
    • Centre Hospitalier Universitaire Saint Pierre
  • Ghent, Belgium, 9000
    • Ghent University Hospital
  • Hasselt, Belgium, 3500
    • Jessa Ziekenhuis
  • Kortrijk, Belgium, 8500
    • AZ Groeninge
  • Leuven, Belgium, 3000
    • Universitair Ziekenhuis Leuven
  • Liège, Belgium, 4000
    • Centre Hospitalier Universitaire de Liège
  • Lodelinsart, Belgium
    • Hôpital Civil Marie Curie
• Canada
  • Ontario
    • Brampton, Ontario, Canada, L6R 3J7
      • William Osler Health System
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottowa Hospital
• Cyprus
  • Nicosia, Cyprus, 2029
    • Nicosia General Hospital
• Czechia
  • Prague, Czechia, 12808
    • Vseobecna fakultni nemocnice v Praze
  • Praha 5, Czechia, 150 06
    • Eticka komise pro multicentircke klinicke hodnoceni Fakultni nemocnice v Motole
  • Praha 8 - Liben, Czechia, 180 81
    • Nemocnice Na Bulovce
• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet
• Estonia
  • Tallinn, Estonia, 13419
    • Põhja-Eesti Regionaalhaigla
  • Tartu, Estonia, 51014
    • Vilnius University
• France
  • Bobigny, France, 93009
    • Hôpital Avicenne
  • Brest Cedex, France, 29609
    • Centre Hospitalier Regional Universitaire Brest Hôpital de la Cavale Blanche à Brest
  • Clermont Ferrand, France, 63000
    • Centre Hospitalier Universitaire Gabriel-Montpied
  • Colmar, France, 68024
    • Hopitaux Civils de Colmar
  • Corbeil Essonnes, France, 91100
    • Centre Hospitalier Sud Francilien
  • Garches, France, 92380
    • Hôpital Raymond Poincaré
  • Orléans, France, 45100
    • Centre Hospitalier Régional D'orléans
  • Poitiers, France, 86021
    • Centre Hospitalier Universitaire de Poitiers
  • Rouen, France, 76031
    • Hôpital Charles-Nicolle
  • Toulouse, France, 31300
    • Hopital Purpan
• Germany
  • Bochum, Germany, 44791
    • Saint Josef Hospital Ruhr Universitaet Bochum
  • Dresden, Germany, 1307
    • Universitätsklinikum Carl Gustav Carus Dresden
  • Essen, Germany, 45147
    • Universitätsklinikum
  • Freiburg, Germany, 79106
    • Universitätsklinikum Freiburg
  • Göttingen, Germany, 37075
    • Universitatsmedizin Gottingen
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Heidelberg, Germany, 69120
    • Universitätsklinikum Heidelberg
  • Homburg, Germany, 66421
    • Universitätsklinikum des Saarlandes
  • Regensburg, Germany, 93053
    • Caritas-Krankenhaus St. Josef
  • Würzburg, Germany, 97074
    • Klinikum Würzburg Mitte
• Greece
  • Patra, Greece, 25404
    • University General Hospital of Patras Panagia I Voithia
  • Thessaloniki, Greece, 570 10
    • General Hospital of Thessaloniki George Papanikolaou
• Hungary
  • Debrecen, Hungary, H-4031
    • Kenézy Gyula Kórház És Rendelőintézet
• Iceland
  • Reykjavik, Iceland, 101
    • Landspitali
• Ireland
  • Tralee, Ireland
    • Kerry University Hospital
• Israel
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center
  • Petah Tikva, Israel, 49372
    • Hasharon Hospital
  • Ramat Gan, Israel, 52621
    • Sheba Medical Center at Tel Hashomer
• Italy
  • Ancona, Italy, 60020
    • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
  • Bari, Italy, 70124
    • Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari
  • Bologna, Italy, 40138
    • Azienda Ospedaliero Universitaria
  • Brescia, Italy, 25123
    • asst spedali civili di brescia
  • Catania, Italy, 95122
    • Presidio Ospedaliero Garibaldi-Nesima
  • Florence, Italy, 50134
    • Azienda Ospedaliero - Universitaria Careggi
  • Genova, Italy, 16132
    • Ospedale Policlinico San Martino
  • Milano, Italy, 20122
    • Ospedale Maggiore Policlinico
  • Monza, Italy, 20900
    • Ospedale San Gerardo di Monza
  • Napoli, Italy, 80131
    • Azienda Ospedaliera Dei Colli
  • Pisa, Italy, 56124
    • Azienda Ospedaliero-Universitaria Pisana
  • Roma, Italy, 00149
    • IRCCS Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani
  • Turin, Italy, 10126
    • Azienda Ospedaliero Universitaria
• Lithuania
  • Kaunas, Lithuania, 50161
    • Hospital of Lithuanian University of Health Sciences Kauno Klinikos
  • Vilnius, Lithuania, 08661
    • Vilnius University
• Netherlands
  • Nijmegen, Netherlands, 6525 GA
    • Radboud Universitair Medisch Centrum
  • The Hague, Netherlands, 2545 AA
    • HagaZiekenhuis
• Poland
  • Krakow, Poland, 30-688
    • Szpital Uniwersytecki w Krakowie
  • Lodz, Poland, 91347
    • Wojewódzki Specjalistyczny Szpital im. dr. Wł. Biegańskiego
  • Poznan, Poland, 61-285
    • Wielospecjalistyczny Szpital Miejski Im Józefa Strusia Zakład Opiekuńczo Leczniczy
  • Tychy, Poland, 43-100
    • Wojewódzki Szpital Specjalistyczny Megrez Sp. z o.o.
• Portugal
  • Lisboa, Portugal, 1050-099
    • Centro Hospitalar Universitário de Lisboa Central - Hospital Curry Cabral
  • Porto, Portugal, 4200-319
    • Centro Hospitalar Universitário de São João
  • Porto, Portugal, 4099-001
    • Centro Hospitalar Universitário do Porto E.P.E.
  • Vila Nova de Gaia, Portugal, 4434-502
    • Centro Hospitalar de Vila Nova de Gaia/Espinho
• Romania
  • Bucharest, Romania, 21105
    • Institutul National de Boli Infectioase Prof. Dr. Matei Bals
  • Iasi, Romania, RO-700116
    • Spitalul Clinic de Boli Infecţioase Sfânta Parascheva Iaşi
  • Timisoara, Romania, RO-300310
    • Clinical hospital for infectious disease
• Slovakia
  • Košice, Slovakia, 041 90
    • Univerzitná Nemocnica L. Pasteura Košice - Pracovisko Rastislavova 43
• Slovenia
  • Ljubljana, Slovenia, 1000
    • Univerzitetni klinicni center Ljubljana
  • Maribor, Slovenia, SI 2000
    • Univerzitetni Klinicni Center Maribor
• Spain
  • Badalona, Spain, 08916
    • Hospital Universitari Germans Trias i Pujol
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon
  • Oviedo, Spain, 33011
    • Hospital Universitario Central de Asturias
  • Palma de Mallorca, Spain, 07120
    • Hospital Universitario Son Espases
  • Salamanca, Spain, 37007
    • Hospital Clinico Universitario de Salamanca
  • San Sebastian, Spain, 20014
    • Hospital Universitario Donostia
  • Santa Cruz de Tenerife, Spain, 38010
    • Hospital Virgen de la Salud
  • Toledo, Spain, 45004
    • Hospital Virgen de la Salud
  • Valladolid, Spain, 47003
    • Hospital Clinico Universitario De Valladolid
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet
• Switzerland
  • Aarau, Switzerland, 5000
    • Kantonsspital Aarau
  • Basel, Switzerland, 4051
    • University Hospital Basel
  • Biel, Switzerland, 2502
    • Spitalzentrum Biel
  • Chur, Switzerland, 7000
    • Kantonsspital Graubünden
  • Lausanne, Switzerland, 1011
    • Centre Hospitalier Universitaire Vaudois Lausanne
  • Luzern, Switzerland, 6000
    • Luzerner Kantonsspital
  • Sion, Switzerland, 1951
    • Hôpital du Valais -Hôpital de Sion
• United Kingdom
  • Cardiff, United Kingdom, CF14 4XW
    • University Hospital of Wales, Cardiff and Vale NHS Trust
  • London, United Kingdom, SW17 0QT
    • St. George's Hospital
  • London, United Kingdom, SE1 7EH
    • Guy's and St Thomas' NHS Foundation Trust
  • London, United Kingdom, E1 1FR
    • Barts Health NHS Trust
  • Southampton, United Kingdom, SO16 6YD
    • Southampton University Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama- Birmingham
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner- University Medical Center Phoenix
  • California
    • Fresno, California, United States, 93721
      • Community Regional Medical Centers (CRMC)
    • Fullerton, California, United States, 92835
      • St. Jude Medical Center
    • La Jolla, California, United States, 92037
      • Scripps Memorial Hospital La Jolla
    • Long Beach, California, United States, 90806
      • Long Beach Memorial Medical Center
    • Pasadena, California, United States, 91105
      • Huntington Hospital
    • San Diego, California, United States, 92064
      • Scripps Mercy Hospital
    • San Francisco, California, United States, 94115
      • California Pacific Medical Center
    • San Francisco, California, United States, 94143
      • University of California, Medical Center (Parnassus Campus)
    • San Jose, California, United States, 95118
      • Regional Medical Center
    • San Mateo, California, United States, 94304-1509
      • San Mateo Medical Center
    • Santa Rosa, California, United States, 95405
      • Santa Rosa Memorial Hospital
    • Thousand Oaks, California, United States, 91360
      • Los Robles Regional Medical Center
    • Whittier, California, United States, 90602
      • PIH Health Whittier Hospital
  • Colorado
    • Aurora, Colorado, United States, 80012
      • The Medical Center of Aurora
    • Denver, Colorado, United States, 80220
      • Rose Medical Center
    • Englewood, Colorado, United States, 80113
      • Swedish Medical Center
  • Connecticut
    • Greenwich, Connecticut, United States, 06830
      • Greenwich Hospital
    • Middletown, Connecticut, United States, 64587
      • Middlesex Health
    • New Britain, Connecticut, United States, 06052
      • The Hospital of Central Connecticut
    • Stamford, Connecticut, United States, 06904
      • The Stamford Health Medical Group- Pulmonary Associates
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University Hospital
  • Florida
    • Aventura, Florida, United States, 33180
      • Aventura Hospital and Medical Center
    • Fort Pierce, Florida, United States, 34982
      • Lawnwood Regional Medical Center
    • Hollywood, Florida, United States, 33021
      • Memorial Regional Hospital
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic in Florida
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Medical Center
    • Orlando, Florida, United States, 32803
      • AdventHealth Orlando, Investigational Drug Services
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Atlanta Hospital
    • Atlanta, Georgia, United States, 30312
      • Wellstar Atlanta Medical Center
    • Columbus, Georgia, United States, 31901
      • Piedmont Columbus Regional-Midtown Hospital
    • Decatur, Georgia, United States, 30030
      • Grady Health System- Grady Memorial Hospital
    • Fayetteville, Georgia, United States, 10043
      • Piedmont Fayette Hospital
    • Savannah, Georgia, United States, 31404
      • Memorial Health University Medical Center
    • Thomasville, Georgia, United States, 31792
      • John D. Archbold Memorial Hospital
  • Illinois
    • Chicago, Illinois, United States, 60025
      • Swedish Hospital
    • Chicago, Illinois, United States, 60616
      • Mercy Hospital & Medical Center
    • Lake Forest, Illinois, United States, 60045
      • Northwestern Lake Forest Hospital
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
    • Winfield, Illinois, United States, 60190
      • Northwestern Medicine Central DuPage Hospital
  • Indiana
    • Carmel, Indiana, United States, 46032
      • St. Vincent Hospital And Health Care Center, Inc.
    • Indianapolis, Indiana, United States, 46202
      • Richard L Roudebush Indianapolis VA
    • Noblesville, Indiana, United States, 46060
      • Riverview Health
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Our Lady of the Lakes Regional Medical Center
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
    • New Orleans, Louisiana, United States, 70112
      • Touro Infirmary
    • Slidell, Louisiana, United States, 70458
      • Slidell Memorial Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
    • Baltimore, Maryland, United States, 21217
      • Mercy Medical Center
    • Prince Frederick, Maryland, United States, 20678
      • CalvertHealth Medical Center
    • Towson, Maryland, United States, 21204
      • University of Maryland St. Joseph Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02135
      • Steward St. Elizabeth's Medical Center of Boston, Inc.
    • Cambridge, Massachusetts, United States, 02141
      • Cambridge Health Alliance
    • Fall River, Massachusetts, United States, 02720
      • Charlton Memorial Hospital
    • Lawrence, Massachusetts, United States, 01841
      • Lawrence General Hospital
    • Lowell, Massachusetts, United States, 01854
      • Lowell General Hospital
    • South Weymouth, Massachusetts, United States, 02190
      • South Shore Hospital
    • Worcester, Massachusetts, United States, 01655
      • UMASS Memorial Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48106-0995
      • St. Joseph Mercy Hospital
    • Commerce, Michigan, United States, 48382
      • Huron Valley-Sinai Hospital
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Detroit, Michigan, United States, 48201
      • Wayne Statue University/ Detroit Receiving Hospital
    • Flint, Michigan, United States, 48532
      • McLaren Health Care Corporation
    • Kalamazoo, Michigan, United States, 49007
      • Bronson Methodist Hospital
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New Jersey
    • Bayonne, New Jersey, United States, 07002
      • CarePoint Health Bayonne Medical Center
    • Belleville, New Jersey, United States, 07109
      • Clara Maass Medical Center
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital
    • Edison, New Jersey, United States, 08820
      • Hackensack Meridian Health - JFK Medical Center
    • Elizabeth, New Jersey, United States, 07207
      • Trinitas Regional Medical Center
    • Englewood, New Jersey, United States, 07631
      • Englewood Health
    • Flemington, New Jersey, United States, 08822
      • Hunterdon Medical Center
    • Freehold, New Jersey, United States, 07728
      • CentraState Medical Center
    • Hamilton, New Jersey, United States, 08690
      • Robert Wood Johnson University Hospital Hamilton
    • Jersey City, New Jersey, United States, 07302
      • Jersey City Medical Center
    • Jersey City, New Jersey, United States, 07306
      • Christ Hospital- Carepoint Health
    • Long Branch, New Jersey, United States, 07740
      • Monmouth Medical Center
    • Morristown, New Jersey, United States, 07960
      • Atlantic Health System/ Morristown Medical Center
    • Neptune, New Jersey, United States, 07753
      • Jersey Shore University Medical Center
    • New Brunswick, New Jersey, United States, 08901
      • Saint Peter's University Hospital
    • Newark, New Jersey, United States, 07103
      • University Hospital
    • Newark, New Jersey, United States, 07102
      • Saint Michael's Medical Center
    • Oakhurst, New Jersey, United States, 07755
      • Ocean Medical Center
    • Red Bank, New Jersey, United States, 07701
      • Bayshore Medical Center
    • Ridgewood, New Jersey, United States, 07450
      • The Valley Hospital
    • Summit, New Jersey, United States, 07901
      • Atlantic Health System/Overlook Medical Center
    • Teaneck, New Jersey, United States, 07666
      • Holy Name Medical Center
    • Trenton, New Jersey, United States, 08638
      • Capital Health
    • Voorhees, New Jersey, United States, 08043
      • Virtua Health Voorhees Campus
  • New York
    • Albany, New York, United States, 12208
      • St. Peter's Hospital
    • Astoria, New York, United States, 11102
      • Mount Sinai Queens
    • Bay Shore, New York, United States, 11706
      • Good Samaritan Hospital Medical Center
    • Bay Shore, New York, United States, 11706
      • Southside Hospital
    • Bronx, New York, United States, 10451
      • Lincoln Medical Center
    • Bronx, New York, United States, 10457
      • St Barnabus Hospital
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center, Weiler Campus
    • Bronx, New York, United States, 10467-2490
      • Montefiore Health System Moses Medical Center
    • Brooklyn, New York, United States, 11219
      • Maimonides Medical Center
    • Brooklyn, New York, United States, 11212
      • Brookdale University Hospital and Medical Center
    • Brooklyn, New York, United States, 11201
      • The Brooklyn Hospital Center
    • Brooklyn, New York, United States, 11203
      • Kingsbrook Jewish Medical Center
    • Brooklyn, New York, United States, 11203
      • University Hospital Brooklyn (SUNY Downstate)
    • Brooklyn, New York, United States, 11206
      • Woodhull Medical Center
    • Brooklyn, New York, United States, 11207
      • Kings County Hospital Center
    • Brooklyn, New York, United States, 11209
      • New York Harbor VA Medical Center
    • Brooklyn, New York, United States, 11213
      • Interfaith Medical Center
    • Brooklyn, New York, United States, 11215
      • NewYork-Presbyterian Brooklyn Methodist Hospital
    • Brooklyn, New York, United States, 11220
      • NYU Langone Hospital - Brooklyn
    • Brooklyn, New York, United States, 11234
      • Mount Sinai Brooklyn
    • Brooklyn, New York, United States, 11235
      • New York City Health and Hospitals - Coney Island
    • Buffalo, New York, United States, 14203
      • Kaleida Health System
    • East Meadow, New York, United States, 11554
      • Nassau University Medical Center
    • Flushing, New York, United States, 11355
      • New York Presbyterian- Queens
    • Glens Falls, New York, United States, 12801
      • Glens Falls Hospital
    • Jamaica, New York, United States, 11432
      • Queens Hospital Center
    • New York, New York, United States, 10065
      • Memorial Sloan-Kettering Cancer Center
    • New York, New York, United States, 10016
      • NYU Langone Health
    • New York, New York, United States, 10021
      • Hospital for Special Surgery
    • New York, New York, United States, 10029
      • New York City Health and New York City Health and Hospitals - Metropolitan- Metropolitan
    • New York, New York, United States, 10032
      • NewYork-Presyterian/Columbia University Irving Medical Center- Milstein Hospital
    • New York, New York, United States, 10037
      • New York City Health + Hospitals / Harlem
    • New York, New York, United States, 10038
      • New York Presbyterian Lower Manhattan Hospital
    • Oceanside, New York, United States, 11572
      • Mount Sinai South Nassau
    • Poughkeepsie, New York, United States, 12601
      • Vassar Brothers Medical Center
    • Rochester, New York, United States, 14621
      • Rochester General Hospital
    • Roslyn, New York, United States, 11576
      • St. Francis Hospital
    • Schenectady, New York, United States, 12308
      • Ellis Hospital
    • Staten Island, New York, United States, 10305
      • Staten Island University Hospital- Northwell Health (North Campus)
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Hospital/ Stony Brook Children's
    • Troy, New York, United States, 12180
      • Samaritan Hospital
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Hospitals
    • Charlotte, North Carolina, United States, 28209
      • Atrium Health- Carolinas Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center
    • Columbus, Ohio, United States, 43210
      • The Ohio State University College of Medicine
    • Kettering, Ohio, United States, 45429
      • Kettering Medical Center
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Saint Francis Hospital
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's Hospital - Bethlehem Campus
    • Darby, Pennsylvania, United States, 19023
      • Mercy Catholic Medical Center - Fitzgerald Campus
    • Langhorne, Pennsylvania, United States, 18940
      • St Mary Medical Center
    • Philadelphia, Pennsylvania, United States, 19141
      • Einstein Medical Center Philadelphia
    • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia VA Medical Center
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Health Network
  • Rhode Island
    • Providence, Rhode Island, United States, 02908
      • Roger Williams Medical Center
    • Warwick, Rhode Island, United States, 02886
      • Kent Hospital
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • St. Francis Hospital
    • West Columbia, South Carolina, United States, 29169
      • Lexington Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • TriStar Centennial Medical center
  • Texas
    • Austin, Texas, United States, 78705
      • St. David's South Austin Medical Center
    • Dallas, Texas, United States, 75231
      • Texas Health Presbyterian Hospital Dallas
    • Galveston, Texas, United States, 77555-0435
      • Texas Department of Criminal Justice Hospital (Hospital Galveston)/University of Texas Medical Branch
    • Houston, Texas, United States, 77082
      • HCA Houston Healthcare West
    • Lubbock, Texas, United States, 79410
      • Covenant Medical Center
    • Mansfield, Texas, United States, 76063
      • Methodist Mansfield Medical Center
    • San Antonio, Texas, United States, 78229
      • Methodist Healthcare System of San Antonio, Ltd. LLP, dha, Methodist Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Saint Mark's Hospital
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Medical Campus
    • Richmond, Virginia, United States, 23229
      • Henrico Doctors Hospital
    • Roanoke, Virginia, United States, 24014
      • Carilion Medical Center
  • Washington
    • Bellevue, Washington, United States, 98004
      • Overlake Hospital Medical Center
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center- Montlake Campus
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

Description

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)

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Investigators: Study Director: Gilead Study Director, Gilead Sciences

Study record dates

Study Registration Dates

• First Submitted: March 24, 2020
• First Submitted That Met QC Criteria: March 24, 2020
• First Posted (Actual): March 27, 2020

Study Record Updates

• Last Update Posted (Actual): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 10, 2020
• Last Verified: November 1, 2020

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Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Infections; Communicable Diseases; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Remdesivir
• Other Study ID Numbers: GS-US-540-5821; 2020-001453-49 (EudraCT Number)