AzTrials
AzTrials

SARS-CoV2 InfectionNCT04323761

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

A study testing Remdesivir in people with SARS-CoV2 Infection, run by Gilead Sciences at 272 sites in 27 countries.

Approved For Marketing

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
SARS-CoV2 Infection
What is being tested?
Remdesivir
Type of treatment
Injection or infusion
How many people
Not given
Where
272 sitesin 27 countries
Study dates
Start not givento not given
Phase
Expanded access
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

272 sites in 27 countries.

272 sites in 27 countries

United States165 sites

  • St. Peter's Hospital

    Albany, New York, 12208

  • St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • Mount Sinai Queens

    Astoria, New York, 11102

  • Piedmont Atlanta Hospital

    Atlanta, Georgia, 30309

  • Wellstar Atlanta Medical Center

    Atlanta, Georgia, 30312

  • The Medical Center Of Aurora

    Aurora, Colorado, 80012

  • St. David's South Austin Medical Center

    Austin, Texas, 78705

  • Aventura Hospital and Medical Center

    Aventura, Florida, 33180

  • University of Maryland

    Baltimore, Maryland, 21201

  • Mercy Medical Center

    Baltimore, Maryland, 21217

  • Our Lady of the Lakes Regional Medical Center

    Baton Rouge, Louisiana, 70808

  • Good Samaritan Hospital Medical Center

    Bay Shore, New York, 11706

  • Southside Hospital

    Bay Shore, New York, 11706

  • CarePoint Health Bayonne Medical Center

    Bayonne, New Jersey, 07002

  • Clara Maass Medical Center

    Belleville, New Jersey, 07109

  • Overlake Hospital Medical Center

    Bellevue, Washington, 98004

  • St. Luke's Hospital - Bethlehem Campus

    Bethlehem, Pennsylvania, 18015

  • University of Alabama- Birmingham

    Birmingham, Alabama, 35294

  • Steward St. Elizabeth's Medical Center of Boston, Inc.

    Boston, Massachusetts, 02135

  • The Brooklyn Hospital Center

    Brooklyn, New York, 11201

  • Kingsbrook Jewish Medical Center

    Brooklyn, New York, 11203

  • University Hospital Brooklyn (SUNY Downstate)

    Brooklyn, New York, 11203

  • Woodhull Medical Center

    Brooklyn, New York, 11206

  • Kings County Hospital Center

    Brooklyn, New York, 11207

  • New York Harbor VA Medical Center

    Brooklyn, New York, 11209

  • Brookdale University Hospital and Medical Center

    Brooklyn, New York, 11212

  • Interfaith Medical Center

    Brooklyn, New York, 11213

  • NewYork-Presbyterian Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

  • Maimonides Medical Center

    Brooklyn, New York, 11219

  • NYU Langone Hospital - Brooklyn

    Brooklyn, New York, 11220

  • Mount Sinai Brooklyn

    Brooklyn, New York, 11234

  • New York City Health and Hospitals - Coney Island

    Brooklyn, New York, 11235

  • Kaleida Health System

    Buffalo, New York, 14203

  • Cambridge Health Alliance

    Cambridge, Massachusetts, 02141

  • Cooper University Hospital

    Camden, New Jersey, 08103

  • St. Vincent Hospital and Health Care Center, Inc.

    Carmel, Indiana, 46032

  • UNC Hospitals

    Chapel Hill, North Carolina, 27599

  • Atrium Health- Carolinas Medical Center

    Charlotte, North Carolina, 28209

  • Swedish Hospital

    Chicago, Illinois, 60025

  • Mercy Hospital & Medical Center

    Chicago, Illinois, 60616

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Piedmont Columbus Regional-Midtown Hospital

    Columbus, Georgia, 31901

  • The Ohio State University College of Medicine

    Columbus, Ohio, 43210

  • Huron Valley-Sinai Hospital

    Commerce, Michigan, 48382

  • Texas Health Presbyterian Hospital Dallas

    Dallas, Texas, 75231

  • Mercy Catholic Medical Center - Fitzgerald Campus

    Darby, Pennsylvania, 19023

  • Grady Health System- Grady Memorial Hospital

    Decatur, Georgia, 30030

  • Rose Medical Center

    Denver, Colorado, 80220

  • Wayne Statue University/ Detroit Receiving Hospital

    Detroit, Michigan, 48201

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Nassau University Medical Center

    East Meadow, New York, 11554

  • Hackensack Meridian Health - JFK Medical Center

    Edison, New Jersey, 08820

  • Trinitas Regional Medical Center

    Elizabeth, New Jersey, 07207

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • Englewood Health

    Englewood, New Jersey, 07631

  • Charlton Memorial Hospital

    Fall River, Massachusetts, 02720

  • Inova Fairfax Medical Campus

    Falls Church, Virginia, 22042

  • Piedmont Fayette Hospital

    Fayetteville, Georgia, 10043

  • Hunterdon Medical Center

    Flemington, New Jersey, 08822

  • McLaren Health Care Corporation

    Flint, Michigan, 48532

  • New York Presbyterian- Queens

    Flushing, New York, 11355

  • CentraState Medical Center

    Freehold, New Jersey, 07728

  • Community Regional Medical Centers (CRMC)

    Fresno, California, 93721

  • Lawnwood Regional Medical Center

    Ft. Pierce, Florida, 34982

  • St. Jude Medical Center

    Fullerton, California, 92835

  • Texas Department of Criminal Justice Hospital (Hospital Galveston)/University of Texas Medical Branch

    Galveston, Texas, 77555-0435

  • Glens Falls Hospital

    Glens Falls, New York, 12801

  • St. Francis Hospital

    Greenville, South Carolina, 29607

  • Greenwich Hospital

    Greenwich, Connecticut, 06830

  • Robert Wood Johnson University Hospital Hamilton

    Hamilton, New Jersey, 08690

  • Memorial Regional Hospital

    Hollywood, Florida, 33021

  • HCA Houston Healthcare West

    Houston, Texas, 77082

  • Richard L Roudebush Indianapolis VA

    Indianapolis, Indiana, 46202

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224

  • Queens Hospital Center

    Jamaica, New York, 11432

  • Jersey City Medical Center

    Jersey City, New Jersey, 07302

  • Christ Hospital- Carepoint Health

    Jersey City, New Jersey, 07306

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Scripps Memorial Hospital La Jolla

    La Jolla, California, 92037

  • Northwestern Lake Forest Hospital

    Lake Forest, Illinois, 60045

  • St Mary Medical Center

    Langhorne, Pennsylvania, 18940

  • Lawrence General Hospital

    Lawrence, Massachusetts, 01841

  • Long Beach Memorial Medical Center

    Long Beach, California, 90806

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740

  • Lowell General Hospital

    Lowell, Massachusetts, 01854

  • Covenant Medical Center

    Lubbock, Texas, 79410

  • Methodist Mansfield Medical Center

    Mansfield, Texas, 76063

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Middlesex Health

    Middletown, Connecticut, 64587

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Atlantic Health System/ Morristown Medical Center

    Morristown, New Jersey, 07960

  • TriStar Centennial Medical Center

    Nashville, Tennessee, 37203

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06052

  • Saint Peter's University Hospital

    New Brunswick, New Jersey, 08901

  • Touro Infirmary

    New Orleans, Louisiana, 70112

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • NYU Langone Health

    New York, New York, 10016

  • Hospital for Special Surgery

    New York, New York, 10021

  • New York City Health and New York City Health and Hospitals - Metropolitan- Metropolitan

    New York, New York, 10029

  • NewYork-Presyterian/Columbia University Irving Medical Center- Milstein Hospital

    New York, New York, 10032

  • New York City Health + Hospitals / Harlem

    New York, New York, 10037

  • New York Presbyterian Lower Manhattan Hospital

    New York, New York, 10038

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Saint Michael's Medical Center

    Newark, New Jersey, 07102

  • University Hospital

    Newark, New Jersey, 07103

  • Riverview Health

    Noblesville, Indiana, 46060

  • Ocean Medical Center

    Oakhurst, New Jersey, 07755

  • Mount Sinai South Nassau

    Oceanside, New York, 11572

  • AdventHealth Orlando, Investigational Drug Services

    Orlando, Florida, 32803

  • Huntington Hospital

    Pasadena, California, 91105

  • Philadelphia VA Medical Center

    Philadelphia, Pennsylvania, 19104

  • Einstein Medical Center Philadelphia

    Philadelphia, Pennsylvania, 19141

  • Banner- University Medical Center Phoenix

    Phoenix, Arizona, 85006

  • Allegheny Health Network

    Pittsburgh, Pennsylvania, 15212

  • UPMC

    Pittsburgh, Pennsylvania, 15213

  • Vassar Brothers Medical Center

    Poughkeepsie, New York, 12601

  • CalvertHealth Medical Center

    Prince Frederick, Maryland, 20678

  • Roger Williams Medical Center

    Providence, Rhode Island, 02908

  • Bayshore Medical Center

    Red Bank, New Jersey, 07701

  • Henrico Doctors Hospital

    Richmond, Virginia, 23229

  • The Valley Hospital

    Ridgewood, New Jersey, 07450

  • Carilion Medical Center

    Roanoke, Virginia, 24014

  • Rochester General Hospital

    Rochester, New York, 14621

  • St. Francis Hospital

    Roslyn, New York, 11576

  • Saint Mark's Hospital

    Salt Lake City, Utah, 84124

  • Methodist Healthcare System of San Antonio, Ltd. LLP, dha, Methodist Hospital

    San Antonio, Texas, 78229

  • Scripps Mercy Hospital

    San Diego, California, 92064

  • California Pacific Medical Center

    San Francisco, California, 94115

  • University of California, Medical Center (Parnassus Campus)

    San Francisco, California, 94143

  • Regional Medical Center

    San Jose, California, 95118

  • San Mateo Medical Center

    San Mateo, California, 94304-1509

  • Santa Rosa Memorial Hospital

    Santa Rosa, California, 95405

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

  • Ellis Hospital

    Schenectady, New York, 12308

  • University of Washington Medical Center- Montlake Campus

    Seattle, Washington, 98195

  • Slidell Memorial Hospital

    Slidell, Louisiana, 70458

  • South Shore Hospital

    South Weymouth, Massachusetts, 02190

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • The Stamford Health Medical Group- Pulmonary Associates

    Stamford, Connecticut, 06904

  • Staten Island University Hospital- Northwell Health (North Campus)

    Staten Island, New York, 10305

  • Stony Brook University Hospital/ Stony Brook Children's

    Stony Brook, New York, 11794

  • Atlantic Health System/Overlook Medical Center

    Summit, New Jersey, 07901

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666

  • Lincoln Medical Center

    The Bronx, New York, 10451

  • St Barnabus Hospital

    The Bronx, New York, 10457

  • Montefiore Medical Center, Weiler Campus

    The Bronx, New York, 10461

  • Montefiore Health System Moses Medical Center

    The Bronx, New York, 10467-2490

  • John D. Archbold Memorial Hospital

    Thomasville, Georgia, 31792

  • Los Robles Regional Medical Center

    Thousand Oaks, California, 91360

  • University of Maryland St. Joseph Medical Center

    Towson, Maryland, 21204

  • Capital Health

    Trenton, New Jersey, 08638

  • Samaritan Hospital

    Troy, New York, 12180

  • Saint Francis Hospital

    Tulsa, Oklahoma, 74136

  • Virtua Health Voorhees Campus

    Voorhees Township, New Jersey, 08043

  • Kent Hospital

    Warwick, Rhode Island, 02886

  • George Washington University Hospital

    Washington D.C., District of Columbia, 20037

  • Lexington Medical Center

    West Columbia, South Carolina, 29169

  • PIH Health Whittier Hospital

    Whittier, California, 90602

  • Northwestern Medicine Central DuPage Hospital

    Winfield, Illinois, 60190

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

Italy13 sites

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

    Ancona, 60020

  • Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari

    Bari, 70124

  • Azienda Ospedaliero Universitaria

    Bologna, 40138

  • ASST Spedali Civili di Brescia

    Brescia, 25123

  • Presidio Ospedaliero Garibaldi-Nesima

    Catania, 95122

  • Azienda Ospedaliero - Universitaria Careggi

    Florence, 50134

  • Ospedale Policlinico San Martino

    Genova, 16132

  • Ospedale Maggiore Policlinico

    Milan, 20122

  • Ospedale San Gerardo di Monza

    Monza, 20900

  • Azienda Ospedaliera dei Colli

    Naples, 80131

  • Azienda Ospedaliero-Universitaria Pisana

    Pisa, 56124

  • IRCCS Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani

    Roma, 00149

  • Azienda Ospedaliero Universitaria

    Turin, 10126

Other trials in Italy

France10 sites

  • Hopital Avicenne

    Bobigny, 93009

  • Centre Hospitalier Regional Universitaire Brest Hôpital de la Cavale Blanche à Brest

    Brest, 29609

  • Centre Hospitalier Universitaire Gabriel-Montpied

    Clermont-Ferrand, 63000

  • Hôpitaux Civils de Colmar

    Colmar, 68024

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, 91100

  • Hôpital Raymond Poincaré

    Garches, 92380

  • Centre Hospitalier Régional d'Orléans

    Orléans, 45100

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86021

  • Hôpital Charles-Nicolle

    Rouen, 76031

  • Hôpital Purpan

    Toulouse, 31300

Other trials in France

Germany10 sites

  • Saint Josef Hospital Ruhr Universitaet Bochum

    Bochum, 44791

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 1307

  • Universitatsklinikum

    Essen, 45147

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Universitätsmedizin Göttingen

    Göttingen, 37075

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Universitätsklinikum des Saarlandes

    Homburg, 66421

  • Caritas-Krankenhaus St. Josef

    Regensburg, 93053

  • Klinikum Würzburg Mitte

    Würzburg, 97074

Other trials in Germany

Spain10 sites

  • Hospital Universitari Germans Trias i Pujol

    Badalona, 08916

  • Hospital Universitario Donostia

    Donostia / San Sebastian, 20014

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

  • Hospital Universitario Son Espases

    Palma de Mallorca, 07120

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007

  • Hospital Virgen De La Salud

    Santa Cruz de Tenerife, 38010

  • Hospital Virgen De La Salud

    Toledo, 45004

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47003

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Belgium7 sites

  • Centre Hospitalier Universitaire Saint Pierre

    Brussels, 1000

  • Ghent University Hospital

    Ghent, 9000

  • Jessa Ziekenhuis

    Hasselt, 3500

  • AZ Groeninge

    Kortrijk, 8500

  • Universitair Ziekenhuis Leuven

    Leuven, 3000

  • Centre Hospitalier Universitaire de Liège

    Liège, 4000

  • Hôpital Civil Marie Curie

    Lodelinsart

Other trials in Belgium

Switzerland7 sites

  • Kantonsspital Aarau

    Aarau, 5000

  • University Hospital Basel

    Basel, 4051

  • Spitalzentrum Biel

    Biel, 2502

  • Kantonsspital Graubünden

    Chur, 7000

  • Centre Hospitalier Universitaire Vaudois Lausanne

    Lausanne, 1011

  • Luzerner Kantonsspital

    Lucerne, 6000

  • Hôpital du Valais -Hôpital de Sion

    Sion, 1951

Other trials in Switzerland

Australia5 sites

  • St. Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Gold Coast Hospital

    Southport, 4215

Other trials in Australia

Austria5 sites

  • Landeskrankenhaus Graz West

    Graz, 8020

  • Universitätsklinik für Innere Medizin II

    Innsbruck, 06020

  • Kepler Universitätsklinikum

    Linz, A-4020

  • Sozialmedizinisches Zentrum Süd - Kaiser-Franz-Josef-Spital

    Vienna, 1100

  • Medical University and General Hospital Vienna

    Vienna

Other trials in Austria

United Kingdom5 sites

  • University Hospital of Wales, Cardiff and Vale NHS Trust

    Cardiff, CF14 4XW

  • Barts Health NHS Trust

    London, E1 1FR

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 7EH

  • St. George's Hospital

    London, SW17 0QT

  • Southampton University Hospital

    Southampton, SO16 6YD

Other trials in United Kingdom

Poland4 sites

  • Szpital Uniwersytecki w Krakowie

    Krakow, 30-688

  • Wojewódzki Specjalistyczny Szpital im. dr. Wł. Biegańskiego

    Lodz, 91347

  • Wielospecjalistyczny Szpital Miejski Im Józefa Strusia Zakład Opiekuńczo Leczniczy

    Poznan, 61-285

  • Wojewódzki Szpital Specjalistyczny Megrez Sp. z o.o.

    Tychy, 43-100

Other trials in Poland

Portugal4 sites

  • Centro Hospitalar Universitário de Lisboa Central - Hospital Curry Cabral

    Lisbon, 1050-099

  • Centro Hospitalar Universitário do Porto E.P.E.

    Porto, 4099-001

  • Centro Hospitalar Universitário De São João

    Porto, 4200-319

  • Centro Hospitalar de Vila Nova de Gaia/Espinho

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Czechia3 sites

  • Všeobecná fakultní nemocnice v Praze

    Prague, 12808

  • Eticka komise pro multicentircke klinicke hodnoceni Fakultni nemocnice v Motole

    Prague, 150 06

  • Nemocnice Na Bulovce

    Praha 8 - Liben, 180 81

Other trials in Czechia

Israel3 sites

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Hasharon Hospital

    Petah Tikva, 49372

  • Sheba Medical Center at Tel Hashomer

    Ramat Gan, 52621

Other trials in Israel

Romania3 sites

  • Institutul National de Boli Infectioase Prof. Dr. Matei Bals

    Bucharest, 21105

  • Spitalul Clinic de Boli Infecţioase Sfânta Parascheva Iaşi

    Iași, RO-700116

  • Clinical hospital for infectious disease

    Timișoara, RO-300310

Other trials in Romania

Canada2 sites

  • William Osler Health System

    Brampton, Ontario, L6R 3J7

  • The Ottowa Hospital

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

Estonia2 sites

  • Põhja-Eesti Regionaalhaigla

    Tallinn, 13419

  • Vilnius University

    Tartu, 51014

Other trials in Estonia

Greece2 sites

  • University General Hospital of Patras Panagia I Voithia

    Pátrai, 25404

  • General Hospital of Thessaloniki George Papanikolaou

    Thessaloniki, 570 10

Other trials in Greece

Lithuania2 sites

  • Hospital of Lithuanian University of Health Sciences Kauno klinikos

    Kaunas, 50161

  • Vilnius University

    Vilnius, 08661

Other trials in Lithuania

Netherlands2 sites

  • Radboud Universitair Medisch Centrum

    Nijmegen, 6525 GA

  • HagaZiekenhuis

    The Hague, 2545 AA

Other trials in Netherlands

Slovenia2 sites

  • Univerzitetni Klinicni Center Ljubljana

    Ljubljana, 1000

  • Univerzitetni Klinicni Center Maribor

    Maribor, SI 2000

Other trials in Slovenia

Cyprus1 site

  • Nicosia General Hospital

    Nicosia, 2029

Other trials in Cyprus

Denmark1 site

  • Rigshospitalet

    Copenhagen, 2100

Other trials in Denmark

Hungary1 site

  • Kenézy Gyula Kórház És Rendelőintézet

    Debrecen, H-4031

Other trials in Hungary

Iceland1 site

  • Landspítali

    Reykjavik, 101

Other trials in Iceland

Ireland1 site

  • Kerry University Hospital

    Tralee

Other trials in Ireland

Slovakia1 site

  • Univerzitná Nemocnica L. Pasteura Košice - Pracovisko Rastislavova 43

    Košice, 041 90

Other trials in Slovakia

About this study

Official title: 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.

Being tested
Remdesivir
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RemdesivirDrug

    Also called GS-5734™, Veklury®

    Intravenous infusion administered over a 30 to 120 minute period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT04323761
Sponsor's protocol ID
GS-US-540-5821
Other IDs
2020-001453-49
Status last verified
Nov 2020
First submitted
24 Mar 2020
Last updated
13 Nov 2020
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Remdesivir in people with SARS-CoV2 Infection, run by Gilead Sciences at 272 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 272 sites in United States, Italy, France, Germany, Spain and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04323761.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.

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