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Clinical Trial Details — Status: Approved for marketing

Administrative data

NCT number NCT04323761
Other study ID # GS-US-540-5821
Secondary ID 2020-001453-49
Status Approved for marketing
Phase
First received
Last updated

Study information

Verified date November 2020
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.


Recruitment information / eligibility

Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 12 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Remdesivir
Intravenous infusion administered over a 30 to 120 minute period

Locations

Country Name City State
Australia 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
Austria 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
Belgium 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
Canada William Osler Health System Brampton Ontario
Canada The Ottowa Hospital Ottawa Ontario
Cyprus Nicosia General Hospital Nicosia
Czechia 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
Denmark Rigshospitalet Copenhagen
Estonia Põhja-Eesti Regionaalhaigla Tallinn
Estonia Vilnius University Tartu
France 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
Germany 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
Greece University General Hospital of Patras Panagia I Voithia Patra
Greece General Hospital of Thessaloniki George Papanikolaou Thessaloniki
Hungary Kenézy Gyula Kórház És Rendelointézet Debrecen
Iceland Landspítali Reykjavik
Ireland Kerry University Hospital Tralee
Israel Shaare Zedek Medical Center Jerusalem
Israel Hasharon Hospital Petah Tikva
Israel Sheba Medical Center at Tel Hashomer Ramat Gan
Italy 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
Lithuania Hospital of Lithuanian University of Health Sciences Kauno klinikos Kaunas
Lithuania Vilnius University Vilnius
Netherlands Radboud Universitair Medisch Centrum Nijmegen
Netherlands HagaZiekenhuis The Hague
Poland Szpital Uniwersytecki w Krakowie Krakow
Poland Wojewódzki Specjalistyczny Szpital im. dr. Wl. Bieganskiego Lodz
Poland Wielospecjalistyczny Szpital Miejski Im Józefa Strusia Zaklad Opiekunczo Leczniczy Poznan
Poland Wojewódzki Szpital Specjalistyczny Megrez Sp. z o.o. Tychy
Portugal Centro Hospitalar Universitário de Lisboa Central - Hospital Curry Cabral Lisboa
Portugal Centro Hospitalar Universitário De São João Porto
Portugal Centro Hospitalar Universitário do Porto E.P.E. Porto
Portugal Centro Hospitalar de Vila Nova de Gaia/Espinho Vila Nova de Gaia
Romania Institutul National de Boli Infectioase Prof. Dr. Matei Bals Bucharest
Romania Spitalul Clinic de Boli Infectioase Sfânta Parascheva Iasi Iasi
Romania Clinical hospital for infectious disease Timisoara
Slovakia Univerzitná Nemocnica L. Pasteura Košice - Pracovisko Rastislavova 43 Košice
Slovenia Univerzitetni Klinicni Center Ljubljana Ljubljana
Slovenia Univerzitetni Klinicni Center Maribor Maribor
Spain 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
Switzerland 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
United Kingdom 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 States St. Peter's Hospital Albany New York
United States St. Joseph Mercy Hospital Ann Arbor Michigan
United States Mount Sinai Queens Astoria New York
United States Piedmont Atlanta Hospital Atlanta Georgia
United States Wellstar Atlanta Medical Center Atlanta Georgia
United States The Medical Center Of Aurora Aurora Colorado
United States St. David's South Austin Medical Center Austin Texas
United States Aventura Hospital and Medical Center Aventura Florida
United States Mercy Medical Center Baltimore Maryland
United States University of Maryland Baltimore Maryland
United States Our Lady of the Lakes Regional Medical Center Baton Rouge Louisiana
United States Good Samaritan Hospital Medical Center Bay Shore New York
United States Southside Hospital Bay Shore New York
United States CarePoint Health Bayonne Medical Center Bayonne New Jersey
United States Clara Maass Medical Center Belleville New Jersey
United States Overlake Hospital Medical Center Bellevue Washington
United States St. Luke's Hospital - Bethlehem Campus Bethlehem Pennsylvania
United States University of Alabama- Birmingham Birmingham Alabama
United States Steward St. Elizabeth's Medical Center of Boston, Inc. Boston Massachusetts
United States Lincoln Medical Center Bronx New York
United States Montefiore Health System Moses Medical Center Bronx New York
United States Montefiore Medical Center, Weiler Campus Bronx New York
United States St Barnabus Hospital Bronx New York
United States Brookdale University Hospital and Medical Center Brooklyn New York
United States Interfaith Medical Center Brooklyn New York
United States Kings County Hospital Center Brooklyn New York
United States Kingsbrook Jewish Medical Center Brooklyn New York
United States Maimonides Medical Center 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 New York Harbor VA Medical Center Brooklyn New York
United States NewYork-Presbyterian Brooklyn Methodist Hospital Brooklyn New York
United States NYU Langone Hospital - Brooklyn Brooklyn New York
United States The Brooklyn Hospital Center Brooklyn New York
United States University Hospital Brooklyn (SUNY Downstate) Brooklyn New York
United States Woodhull Medical Center Brooklyn New York
United States Kaleida Health System Buffalo New York
United States Cambridge Health Alliance Cambridge Massachusetts
United States Cooper University Hospital Camden New Jersey
United States St. Vincent Hospital and Health Care Center, Inc. Carmel Indiana
United States UNC Hospitals Chapel Hill North Carolina
United States Atrium Health- Carolinas Medical Center Charlotte North Carolina
United States Mercy Hospital & Medical Center Chicago Illinois
United States Swedish Hospital Chicago Illinois
United States MetroHealth Medical Center Cleveland Ohio
United States Piedmont Columbus Regional-Midtown Hospital Columbus Georgia
United States The Ohio State University College of Medicine Columbus Ohio
United States Huron Valley-Sinai Hospital Commerce Michigan
United States Texas Health Presbyterian Hospital Dallas Dallas Texas
United States Mercy Catholic Medical Center - Fitzgerald Campus Darby Pennsylvania
United States Grady Health System- Grady Memorial Hospital Decatur Georgia
United States Rose Medical Center Denver Colorado
United States Henry Ford Health System Detroit Michigan
United States Wayne Statue University/ Detroit Receiving Hospital Detroit Michigan
United States Nassau University Medical Center East Meadow New York
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 Swedish Medical Center Englewood Colorado
United States Charlton Memorial Hospital Fall River Massachusetts
United States Inova Fairfax Medical Campus Falls Church Virginia
United States Piedmont Fayette Hospital Fayetteville Georgia
United States Hunterdon Medical Center Flemington New Jersey
United States McLaren Health Care Corporation Flint Michigan
United States New York Presbyterian- Queens Flushing New York
United States Lawnwood Regional Medical Center Fort Pierce Florida
United States CentraState Medical Center Freehold New Jersey
United States Community Regional Medical Centers (CRMC) Fresno California
United States St. Jude Medical Center Fullerton California
United States Texas Department of Criminal Justice Hospital (Hospital Galveston)/University of Texas Medical Branch Galveston Texas
United States Glens Falls Hospital Glens Falls New York
United States St. Francis Hospital Greenville South Carolina
United States Greenwich Hospital Greenwich Connecticut
United States Robert Wood Johnson University Hospital Hamilton Hamilton New Jersey
United States Memorial Regional Hospital Hollywood Florida
United States HCA Houston Healthcare West Houston Texas
United States Richard L Roudebush Indianapolis VA Indianapolis Indiana
United States University of Mississippi Medical Center Jackson Mississippi
United States Mayo Clinic in Florida Jacksonville Florida
United States Queens Hospital Center Jamaica New York
United States Christ Hospital- Carepoint Health Jersey City New Jersey
United States Jersey City Medical Center Jersey City New Jersey
United States Bronson Methodist Hospital Kalamazoo Michigan
United States Kettering Medical Center Kettering Ohio
United States Scripps Memorial Hospital La Jolla La Jolla California
United States Northwestern Lake Forest Hospital Lake Forest Illinois
United States St Mary Medical Center Langhorne Pennsylvania
United States Lawrence General Hospital Lawrence Massachusetts
United States Long Beach Memorial Medical Center Long Beach California
United States Monmouth Medical Center Long Branch New Jersey
United States Lowell General Hospital Lowell Massachusetts
United States Covenant Medical Center Lubbock Texas
United States Methodist Mansfield Medical Center Mansfield Texas
United States Loyola University Medical Center Maywood Illinois
United States Mount Sinai Medical Center Miami Beach Florida
United States Middlesex Health Middletown Connecticut
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Atlantic Health System/ Morristown Medical Center Morristown New Jersey
United States TriStar Centennial Medical Center Nashville Tennessee
United States Jersey Shore University Medical Center Neptune New Jersey
United States The Hospital of Central Connecticut New Britain Connecticut
United States Saint Peter's University Hospital New Brunswick New Jersey
United States Ochsner Clinic Foundation New Orleans Louisiana
United States Touro Infirmary New Orleans Louisiana
United States Hospital for Special Surgery New York New York
United States Memorial Sloan-Kettering Cancer Center New York New York
United States New York City Health + Hospitals / Harlem 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 New York Presbyterian Lower Manhattan Hospital New York New York
United States NewYork-Presyterian/Columbia University Irving Medical Center- Milstein Hospital New York New York
United States NYU Langone Health New York New York
United States Saint Michael's Medical Center Newark New Jersey
United States University Hospital Newark New Jersey
United States Riverview Health Noblesville Indiana
United States Ocean Medical Center Oakhurst New Jersey
United States Mount Sinai South Nassau Oceanside New York
United States AdventHealth Orlando, Investigational Drug Services Orlando Florida
United States Huntington Hospital Pasadena California
United States Einstein Medical Center Philadelphia Philadelphia Pennsylvania
United States Philadelphia VA Medical Center Philadelphia Pennsylvania
United States Banner- University Medical Center Phoenix Phoenix Arizona
United States Allegheny Health Network Pittsburgh Pennsylvania
United States UPMC Pittsburgh Pennsylvania
United States Vassar Brothers Medical Center Poughkeepsie New York
United States CalvertHealth Medical Center Prince Frederick Maryland
United States Roger Williams Medical Center Providence Rhode Island
United States Bayshore Medical Center Red Bank New Jersey
United States Henrico Doctors Hospital Richmond Virginia
United States The Valley Hospital Ridgewood New Jersey
United States Carilion Medical Center Roanoke Virginia
United States Rochester General Hospital Rochester New York
United States St. Francis Hospital Roslyn New York
United States Washington University School of Medicine Saint Louis Missouri
United States Saint Mark's Hospital Salt Lake City Utah
United States Methodist Healthcare System of San Antonio, Ltd. LLP, dha, Methodist Hospital San Antonio Texas
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 Sarasota Memorial Hospital Sarasota Florida
United States Memorial Health University Medical Center Savannah Georgia
United States Ellis Hospital Schenectady New York
United States University of Washington Medical Center- Montlake Campus Seattle Washington
United States Slidell Memorial Hospital Slidell Louisiana
United States South Shore Hospital South Weymouth Massachusetts
United States The Stamford Health Medical Group- Pulmonary Associates Stamford Connecticut
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 Atlantic Health System/Overlook Medical Center Summit New Jersey
United States Holy Name Medical Center Teaneck New Jersey
United States John D. Archbold Memorial Hospital Thomasville Georgia
United States Los Robles Regional Medical Center Thousand Oaks California
United States University of Maryland St. Joseph Medical Center Towson Maryland
United States Capital Health Trenton New Jersey
United States Samaritan Hospital Troy New York
United States Saint Francis Hospital Tulsa Oklahoma
United States Virtua Health Voorhees Campus Voorhees New Jersey
United States Kent Hospital Warwick Rhode Island
United States George Washington University Hospital Washington District of Columbia
United States Lexington Medical Center West Columbia South Carolina
United States PIH Health Whittier Hospital Whittier California
United States Northwestern Medicine Central DuPage Hospital Winfield Illinois
United States UMass Memorial Medical Center Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  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, 

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