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

Trial Profile

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

Status: Recruiting
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 13 Sep 2020

At a glance

  • Drugs Remdesivir (Primary)
  • Indications COVID 2019 infections; Severe acute respiratory syndrome
  • Focus Adverse reactions; Expanded access
  • Sponsors Gilead Sciences
  • Most Recent Events

    • 29 Apr 2020 According to a Froedtert & the Medical College of Wisconsin media release, Mary Beth Graham, MD, associate chief of the division of Infectious Disease at Medical College of Wisconsin, medical director of Infection Prevention & Control at Froedtert Hospital will be the principal investigator of the study.
    • 29 Apr 2020 According to a Froedtert & the Medical College of Wisconsin media release, the institute has recently granted an approval for the enrollment into Gilead Sciences expanded access program (EAP) to treat COVID-19 patients.
    • 31 Mar 2020 New trial record

Trial Overview

Purpose

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.

Primary Endpoints

The incidence rate of treatment-emergent adverse events.

Other Endpoints

Not Applicable No Aplicable [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -
Severe acute respiratory syndrome treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 2500

  • Sex male & female
  • Age Group ≥ 12 years; adolescent; adult; child; elderly

Patient 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

Patient 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)

Trial Details

Identifiers

Identifier Owner
NCT04323761 ClinicalTrials.gov: US National Institutes of Health
EudraCT2020-001453-49 European Clinical Trials Database
GS-US540-5821 Gilead Sciences

Organisations

  • Sponsors Gilead Sciences
  • Affiliations Gilead Sciences

Trial Dates

  • Initiation Dates

    Actual : 10 Apr 2020

  • End Dates

    Planned : 10 Oct 2020

Other Details

  • Design multicentre; prospective
  • Phase of Trial Clinical Phase Unknown
  • Location Australia; Austria; Belgium; Canada; Cyprus; Czech Republic; Denmark; England; Estonia; France; Germany; Greece; Hungary; Iceland; Ireland; Israel; Italy; Netherlands; Poland; Portugal; Romania; Slovakia; Slovenia; Spain; Switzerland; United Kingdom; USA; Wales
  • Focus Adverse reactions; Expanded access

Interventions

Drugs Route Formulation
RemdesivirPrimary Drug Intravenous Infusion, Injection

Drug: Remdesivir (Intravenous infusion administered over a 30 to 120 minute period) Other Name: GS-5734™, Veklury®

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Gilead Clinical Study Information Center
1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com
show details
, Gilead Sciences
-
Gilead Study Director Gilead Sciences
-

Centres

Centre Name Location Trial Centre Country
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-
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AdventHealth Orlando, Investigational Drug Services Orlando, Florida USA
Allegheny Health Network Pittsburgh, Pennsylvania USA
ASST Spedali Civili di Brescia Brescia Italy
Atlantic Health System/ Morristown Medical Center Morristown, New Jersey USA
Atlantic Health System/Overlook Medical Center Summit, New Jersey USA
Atrium Health- Carolinas Medical Center Charlotte, North Carolina USA
Aventura Hospital and Medical Center Aventura, Florida USA
AZ Groeninge Kortrijk Belgium
Azienda Ospedaliera dei Colli Napoli Italy
Azienda Ospedaliero - Universitaria Careggi Florence Italy
Azienda Ospedaliero Universitaria Bologna Italy
Azienda Ospedaliero Universitaria Turin Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona Ancona Italy
Azienda Ospedaliero-Universitaria Pisana Pisa Italy
Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari Bari Italy
Banner- University Medical Center Phoenix Phoenix, Arizona USA
Barts Health NHS Trust London United-Kingdom
Bayshore Medical Center Red Bank, New Jersey USA
Bronson Methodist Hospital Kalamazoo, Michigan USA
Brookdale University Hospital and Medical Center Brooklyn, New York USA
California Pacific Medical Center San Francisco, California USA
CalvertHealth Medical Center Prince Frederick, Maryland USA
Cambridge Health Alliance Cambridge, Massachusetts USA
Capital Health Trenton, New Jersey USA
CarePoint Health Bayonne Medical Center Bayonne, New Jersey USA
Carilion Medical Center Roanoke, Virginia USA
Caritas-Krankenhaus St. Josef Regensburg Germany
CentraState Medical Center Freehold, New Jersey USA
Centre Hospitalier Regional Universitaire Brest Hôpital de la Cavale Blanche à Brest Brest Cedex France
Centre Hospitalier Régional d'Orléans Orléans France
Centre Hospitalier Sud Francilien Corbeil Essonnes France
Centre Hospitalier Universitaire de Liège Liège Belgium
Centre Hospitalier Universitaire de Poitiers Poitiers France
Centre Hospitalier Universitaire Gabriel-Montpied Clermont Ferrand France
Centre Hospitalier Universitaire Saint Pierre Brussels Belgium
Centre Hospitalier Universitaire Vaudois Lausanne Lausanne Switzerland
Centro Hospitalar de Vila Nova de Gaia/Espinho Vila Nova de Gaia 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
Charlton Memorial Hospital Fall River, Massachusetts USA
Christ Hospital- Carepoint Health Jersey City, New Jersey USA
Clara Maass Medical Center Belleville, New Jersey USA
Clinical hospital for infectious disease Timisoara Romania
Community Regional Medical Centers (CRMC) Fresno, California USA
Cooper University Hospital Camden, New Jersey USA
Covenant Medical Center Lubbock, Texas USA
Einstein Medical Center Philadelphia Philadelphia, Pennsylvania USA
Ellis Hospital Schenectady, New York USA
Englewood Health Englewood, New Jersey USA
Eticka komise pro multicentircke klinicke hodnoceni Fakultni nemocnice v Motole Praha 5 Czech-Republic
General Hospital of Thessaloniki George Papanikolaou Thessaloniki Greece
George Washington University Hospital Washington, District of Columbia USA
Ghent University Hospital Ghent Belgium
Gilead Sciences
-
-
Gilead Sciences
-
-
Glens Falls Hospital Glens Falls, New York USA
Gold Coast Hospital Southport Australia
Good Samaritan Hospital Medical Center Bay Shore, New York USA
Grady Health System- Grady Memorial Hospital Decatur, Georgia USA
Greenwich Hospital Greenwich, Connecticut USA
Guy's and St Thomas' NHS Foundation Trust London United-Kingdom
Hackensack Meridian Health - JFK Medical Center Edison, New Jersey USA
HagaZiekenhuis The Hague Netherlands
Hasharon Hospital Petah Tikva Israel
HCA Houston Healthcare West Houston, Texas USA
Henrico Doctors Hospital Richmond, Virginia USA
Henry Ford Health System Detroit, Michigan USA
Holy Name Medical Center Teaneck, New Jersey USA
Hopital Avicenne Bobigny France
Hospital Clinico Universitario de Salamanca Salamanca Spain
Hospital Clinico Universitario de Valladolid Valladolid Spain
Hospital for Special Surgery New York, New York USA
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitari Germans Trias i Pujol Badalona Spain
Hospital Universitario Central de Asturias Oviedo Spain
Hospital Universitario Donostia San Sebastian Spain
Hospital Universitario Miguel Servet Zaragoza Spain
Hospital Universitario Son Espases Palma de Mallorca Spain
Hospital Virgen De La Salud Santa Cruz de Tenerife Spain
Hospital Virgen De La Salud Toledo Spain
Hunterdon Medical Center Flemington, New Jersey USA
Huntington Hospital Pasadena, California USA
Huron Valley-Sinai Hospital Commerce, Michigan USA
Hôpital Charles-Nicolle Rouen France
Hôpital Civil Marie Curie Lodelinsart Belgium
Hôpital Purpan Toulouse France
Hôpital Raymond Poincaré Garches France
Hôpitaux Civils de Colmar Colmar France
Inova Fairfax Medical Campus Falls Church, Virginia USA
Institutul National de Boli Infectioase Prof. Dr. Matei Bals Bucharest Romania
Interfaith Medical Center Brooklyn, New York USA
IRCCS Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani Roma Italy
Jersey City Medical Center Jersey City, New Jersey USA
Jersey Shore University Medical Center Neptune, New Jersey USA
Jessa Ziekenhuis Hasselt Belgium
John D. Archbold Memorial Hospital Thomasville, Georgia USA
Kaleida Health System Buffalo, New York USA
Kantonsspital Aarau Aarau Switzerland
Kantonsspital Graubünden Chur Switzerland
Kent Hospital Warwick, Rhode Island USA
Kenézy Gyula Kórház És Rendelőintézet Debrecen Hungary
Kepler Universitätsklinikum Linz Austria
Kerry University Hospital Tralee Ireland
Kettering Medical Center Kettering, Ohio USA
Kings County Hospital Center Brooklyn, New York USA
Kingsbrook Jewish Medical Center Brooklyn, New York USA
Klinikum Würzburg Mitte Würzburg Germany
Landeskrankenhaus Graz West Graz Austria
Landspítali Reykjavik Iceland
Lawnwood Regional Medical Center Fort Pierce, Florida USA
Lawrence General Hospital Lawrence, Massachusetts USA
Lexington Medical Center West Columbia, South Carolina USA
Lincoln Medical Center Bronx, New York USA
Long Beach Memorial Medical Center Long Beach, California USA
Los Robles Regional Medical Center Thousand Oaks, California USA
Lowell General Hospital Lowell, Massachusetts USA
Loyola University Medical Center Maywood, Illinois USA
Luzerner Kantonsspital Luzern Switzerland
Maimonides Medical Center Brooklyn, New York USA
Mayo Clinic in Florida Jacksonville, Florida USA
McLaren Health Care Corporation Flint, Michigan USA
Medical College of Wisconsin Milwaukee, Wisconsin USA
Medical University and General Hospital Vienna Vienna Austria
Medizinische Hochschule Hannover Hannover Germany
Memorial Health University Medical Center Savannah, Georgia USA
Memorial Regional Hospital Hollywood, Florida USA
Memorial Sloan-Kettering Cancer Center New York, New York USA
Mercy Catholic Medical Center - Fitzgerald Campus Darby, Pennsylvania USA
Mercy Hospital & Medical Center Chicago, Illinois USA
Mercy Medical Center Baltimore, Maryland USA
Methodist Healthcare System of San Antonio, Ltd. LLP, dha, Methodist Hospital San Antonio, Texas USA
Methodist Mansfield Medical Center Mansfield, Texas USA
MetroHealth Medical Center Cleveland, Ohio USA
Middlesex Health Middletown, Connecticut USA
Monmouth Medical Center Long Branch, New Jersey USA
Montefiore Health System Moses Medical Center Bronx, New York USA
Montefiore Medical Center, Weiler Campus Bronx, New York USA
Mount Sinai Brooklyn Brooklyn, New York USA
Mount Sinai Medical Center Miami Beach, Florida USA
Mount Sinai Queens Astoria, New York USA
Mount Sinai South Nassau Oceanside, New York USA
Nassau University Medical Center East Meadow, New York USA
Nemocnice Na Bulovce Praha 8 - Liben Czech-Republic
New York City Health + Hospitals / Harlem New York, New York USA
New York City Health and Hospitals - Coney Island Brooklyn, New York USA
New York City Health and New York City Health and Hospitals - Metropolitan- Metropolitan New York, New York USA
New York Harbor VA Medical Center Brooklyn, New York USA
New York Presbyterian Lower Manhattan Hospital New York, New York USA
New York Presbyterian- Queens Flushing, New York USA
NewYork-Presbyterian Brooklyn Methodist Hospital Brooklyn, New York USA
NewYork-Presyterian/Columbia University Irving Medical Center- Milstein Hospital New York, New York USA
Nicosia General Hospital Nicosia Cyprus
Northwestern Lake Forest Hospital Lake Forest, Illinois USA
Northwestern Medicine Central DuPage Hospital Winfield, Illinois USA
NYU Langone Health New York, New York USA
NYU Langone Hospital - Brooklyn Brooklyn, New York USA
Ocean Medical Center Oakhurst, New Jersey USA
Ochsner Clinic Foundation New Orleans, Louisiana USA
Ospedale Maggiore Policlinico Milano Italy
Ospedale Policlinico San Martino Genova Italy
Ospedale San Gerardo di Monza Monza Italy
Our Lady of the Lakes Regional Medical Center Baton Rouge, Louisiana USA
Overlake Hospital Medical Center Bellevue, Washington USA
Philadelphia VA Medical Center Philadelphia, Pennsylvania USA
Piedmont Atlanta Hospital Atlanta, Georgia USA
Piedmont Columbus Regional-Midtown Hospital Columbus, Georgia USA
Piedmont Fayette Hospital Fayetteville, Georgia USA
PIH Health Whittier Hospital Whittier, California USA
Presidio Ospedaliero Garibaldi-Nesima Catania Italy
Põhja-Eesti Regionaalhaigla Tallinn Estonia
Queens Hospital Center Jamaica, New York USA
Radboud Universitair Medisch Centrum Nijmegen Netherlands
Regional Medical Center San Jose, California USA
Richard L Roudebush Indianapolis VA Indianapolis, Indiana USA
Rigshospitalet Copenhagen Denmark
Riverview Health Noblesville, Indiana USA
Robert Wood Johnson University Hospital Hamilton Hamilton, New Jersey USA
Rochester General Hospital Rochester, New York USA
Roger Williams Medical Center Providence, Rhode Island USA
Rose Medical Center Denver, Colorado USA
Royal Brisbane and Women's Hospital Herston, Queensland Australia
Saint Francis Hospital Tulsa, Oklahoma USA
Saint Josef Hospital Ruhr Universitaet Bochum Bochum Germany
Saint Mark's Hospital Salt Lake City, Utah USA
Saint Michael's Medical Center Newark, New Jersey USA
Saint Peter's University Hospital New Brunswick, New Jersey USA
Samaritan Hospital Troy, New York USA
San Mateo Medical Center San Mateo, California USA
Santa Rosa Memorial Hospital Santa Rosa, California USA
Sarasota Memorial Hospital Sarasota, Florida USA
Scripps Memorial Hospital La Jolla La Jolla, California USA
Scripps Mercy Hospital San Diego, California USA
Shaare Zedek Medical Center Jerusalem Israel
Sheba Medical Center at Tel Hashomer Ramat Gan Israel
Slidell Memorial Hospital Slidell, Louisiana USA
South Shore Hospital South Weymouth, Massachusetts USA
Southampton University Hospital Southampton United-Kingdom
Southside Hospital Bay Shore, New York USA
Sozialmedizinisches Zentrum Süd - Kaiser-Franz-Josef-Spital Wien Austria
Spitalul Clinic de Boli Infecţioase Sfânta Parascheva Iaşi Iasi Romania
Spitalzentrum Biel Biel Switzerland
St Barnabus Hospital Bronx, New York USA
St Mary Medical Center Langhorne, Pennsylvania USA
St. David's South Austin Medical Center Austin, Texas USA
St. Francis Hospital Greenville, South Carolina USA
St. Francis Hospital Roslyn, New York USA
St. George's Hospital London United-Kingdom
St. Joseph Mercy Hospital Ann Arbor, Michigan USA
St. Jude Medical Center Fullerton, California USA
St. Luke's Hospital - Bethlehem Campus Bethlehem, Pennsylvania USA
St. Peter's Hospital Albany, New York USA
St. Vincent Hospital and Health Care Center, Inc. Carmel, Indiana USA
St. Vincent's Hospital Sydney Darlinghurst, New South Wales Australia
Staten Island University Hospital- Northwell Health (North Campus) Staten Island, New York USA
Steward St. Elizabeth's Medical Center of Boston, Inc. Boston, Massachusetts USA
Stony Brook University Hospital/ Stony Brook Children's Stony Brook, New York USA
Swedish Hospital Chicago, Illinois USA
Swedish Medical Center Englewood, Colorado USA
Szpital Uniwersytecki w Krakowie Krakow Poland
Texas Department of Criminal Justice Hospital (Hospital Galveston)/University of Texas Medical Branch Galveston, Texas USA
Texas Health Presbyterian Hospital Dallas Dallas, Texas USA
The Alfred Hospital Melbourne, Victoria Australia
The Brooklyn Hospital Center Brooklyn, New York USA
The Hospital of Central Connecticut New Britain, Connecticut USA
The Medical Center Of Aurora Aurora, Colorado USA
The Ohio State University College of Medicine Columbus, Ohio USA
The Ottowa Hospital Ottawa, Ontario Canada
The Royal Melbourne Hospital Parkville, Victoria Australia
The Stamford Health Medical Group- Pulmonary Associates Stamford, Connecticut USA
The Valley Hospital Ridgewood, New Jersey USA
Touro Infirmary New Orleans, Louisiana USA
Trinitas Regional Medical Center Elizabeth, New Jersey USA
TriStar Centennial Medical Center Nashville, Tennessee USA
UMass Memorial Medical Center Worcester, Massachusetts USA
UNC Hospitals Chapel Hill, North Carolina USA
Universitair Ziekenhuis Leuven Leuven Belgium
Universitatsklinikum Essen Germany
University General Hospital of Patras Panagia I Voithia Patra Greece
University Hospital Newark, New Jersey USA
University Hospital Basel Basel Switzerland
University Hospital Brooklyn (SUNY Downstate) Brooklyn, New York USA
University Hospital of Wales, Cardiff and Vale NHS Trust Cardiff United-Kingdom
University of Alabama- Birmingham Birmingham, Alabama USA
University of California, Medical Center (Parnassus Campus) San Francisco, California USA
University of Maryland Baltimore, Maryland USA
University of Maryland St. Joseph Medical Center Towson, Maryland USA
University of Mississippi Medical Center Jackson, Mississippi USA
University of Washington Medical Center- Montlake Campus Seattle, Washington USA
Universitätsklinik für Innere Medizin II Innsbruck Austria
Universitätsklinikum Carl Gustav Carus Dresden Dresden Germany
Universitätsklinikum des Saarlandes Homburg Germany
Universitätsklinikum Freiburg Freiburg Germany
Universitätsklinikum Heidelberg Heidelberg Germany
Universitätsmedizin Göttingen Göttingen Germany
Univerzitetni Klinicni Center Ljubljana Ljubljana Slovenia
Univerzitetni Klinicni Center Maribor Maribor Slovenia
Univerzitná Nemocnica L. Pasteura Košice - Pracovisko Rastislavova 43 Košice Slovakia
UPMC Pittsburgh, Pennsylvania USA
Vassar Brothers Medical Center Poughkeepsie, New York USA
Vilnius University Tartu Estonia
Virtua Health Voorhees Campus Voorhees, New Jersey USA
Všeobecná fakultní nemocnice v Praze Prague Czech-Republic
Washington University School of Medicine Saint Louis, Missouri USA
Wayne Statue University/ Detroit Receiving Hospital Detroit, Michigan USA
Wellstar Atlanta Medical Center Atlanta, Georgia USA
Wielospecjalistyczny Szpital Miejski Im Józefa Strusia Zakład Opiekuńczo Leczniczy Poznan Poland
William Osler Health System Brampton, Ontario Canada
Wojewódzki Specjalistyczny Szpital im. dr. Wł. Biegańskiego Lodz Poland
Wojewódzki Szpital Specjalistyczny Megrez Sp. z o.o. Tychy Poland
Woodhull Medical Center Brooklyn, New York USA

Trial History

Event Date Event Type Comment
13 Sep 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 13 Sep 2020
29 Apr 2020 Other trial event According to a Froedtert & the Medical College of Wisconsin media release, Mary Beth Graham, MD, associate chief of the division of Infectious Disease at Medical College of Wisconsin, medical director of Infection Prevention & Control at Froedtert Hospital will be the principal investigator of the study. Updated 05 May 2020
29 Apr 2020 Other trial event According to a Froedtert & the Medical College of Wisconsin media release, the institute has recently granted an approval for the enrollment into Gilead Sciences expanded access program (EAP) to treat COVID-19 patients. Updated 05 May 2020
16 Apr 2020 Other trial event New source identified and integrated European Clinical Trials Database record (EudraCT2020-001453-49) Updated 16 Apr 2020
31 Mar 2020 New trial record New trial record Updated 31 Mar 2020

References

  1. European Clinical Trials Database. Trial-Reg 2016;.

    Available from: URL: https://www.clinicaltrialsregister.eu
  2. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  3. Medical College of Wisconsin. Froedtert & the Medical College of Wisconsin Bolster Resources in Fight Against COVID-19 with Study of Remdesivir. Media-Rel 2020;.

    Media Release
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