Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection
Latest Information Update: 24 May 2022
At a glance
- Drugs Remdesivir (Primary)
- Indications COVID 2019 infections
- Focus Adverse reactions; Expanded access
- Sponsors Gilead Sciences
- 05 Oct 2020 Status changed from recruiting to completed.
- 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.
Most Recent Events
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.
Diseases Treated
Indication | Qualifiers | Patient Segments |
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COVID 2019 infections | treatment | - |
Subjects
- Subject Type patients
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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 |
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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
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Initiation Dates
Actual : 10 Apr 2020
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End Dates
Planned : 10 Oct 2020
Actual : 23 Sep 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; Lithuania; Netherlands; Poland; Portugal; Romania; Slovakia; Slovenia; Spain; Switzerland; United Kingdom; USA; Wales
- Focus Adverse reactions; Expanded access
Interventions
Drugs | Route | Formulation |
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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 |
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Gilead Clinical Study Information Center
1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com
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Gilead Sciences |
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Gilead Study Director | Gilead Sciences |
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Centres
Centre Name | Location | Trial Centre Country |
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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 |
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Gilead Sciences |
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Gilead Sciences International Ltd.
Clinical Trials Mailbox,Flowers Building, Granta Park,Great Abington, Cambridge,CB21 6GT,United Kingdom,+441223897284,clinical.trials@gilead.com
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Great Abington, Cambridge | United-Kingdom |
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 of Lithuanian University of Health Sciences Kauno klinikos | Kaunas | Lithuania |
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 du Valais -Hôpital de Sion | Sion | Switzerland |
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 |
Vilnius University | Vilnius | Lithuania |
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 |
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24 May 2022 | Other trial event | Last checked against European Clinical Trials Database record . Updated 24 May 2022 |
19 Nov 2020 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 19 Nov 2020 |
05 Oct 2020 | Status change - completed | Status changed from recruiting to completed. Updated 08 Oct 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
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ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
European Clinical Trials Database. Trial-Reg 2023;.
Available from: URL: https://www.clinicaltrialsregister.eu -
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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