CD2H COVID-19

Return to Search Results

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

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.

Condition

SARS-CoV2 Infection

Eligibility

Eligible Ages: Over 12 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Phase
Study Type: Expanded Access

Recruiting Locations

University of Alabama- Birmingham
Birmingham 4049979, Alabama 4829764 35294

Banner- University Medical Center Phoenix
Phoenix 5308655, Arizona 5551752 85006

Community Regional Medical Centers (CRMC)
Fresno 5350937, California 5332921 93721

St. Jude Medical Center
Fullerton 5351247, California 5332921 92835

Scripps Memorial Hospital La Jolla
La Jolla 5363943, California 5332921 92037

Long Beach Memorial Medical Center
Long Beach 5367929, California 5332921 90806

Huntington Hospital
Pasadena 5381396, California 5332921 91105

Scripps Mercy Hospital
San Diego 5391811, California 5332921 92064

California Pacific Medical Center
San Francisco 5391959, California 5332921 94115

University of California, Medical Center (Parnassus Campus)
San Francisco 5391959, California 5332921 94143

Regional Medical Center
San Jose 5392171, California 5332921 95118

San Mateo Medical Center
San Mateo 5392423, California 5332921 94304-1509

Santa Rosa Memorial Hospital
Santa Rosa 5393287, California 5332921 95405

Los Robles Regional Medical Center
Thousand Oaks 5402405, California 5332921 91360

PIH Health Whittier Hospital
Whittier 5409059, California 5332921 90602

The Medical Center Of Aurora
Aurora 5412347, Colorado 5417618 80012

Rose Medical Center
Denver 5419384, Colorado 5417618 80220

Swedish Medical Center
Englewood 5421250, Colorado 5417618 80113

Greenwich Hospital
Greenwich 4835395, Connecticut 4831725 06830

Middlesex Health
Middletown 4838633, Connecticut 4831725 64587

The Hospital of Central Connecticut
New Britain 4839292, Connecticut 4831725 06052

The Stamford Health Medical Group- Pulmonary Associates
Stamford 4843564, Connecticut 4831725 06904

George Washington University Hospital
Washington D.C. 4140963, District of Columbia 4138106 20037

Aventura Hospital and Medical Center
Aventura 4146429, Florida 4155751 33180

Lawnwood Regional Medical Center
Ft. Pierce 4156018, Florida 4155751 34982

Memorial Regional Hospital
Hollywood 4158928, Florida 4155751 33021

Mayo Clinic in Florida
Jacksonville 4160021, Florida 4155751 32224

Mount Sinai Medical Center
Miami Beach 4164143, Florida 4155751 33140

AdventHealth Orlando, Investigational Drug Services
Orlando 4167147, Florida 4155751 32803

Sarasota Memorial Hospital
Sarasota 4172131, Florida 4155751 34239

Piedmont Atlanta Hospital
Atlanta 4180439, Georgia 4197000 30309

Wellstar Atlanta Medical Center
Atlanta 4180439, Georgia 4197000 30312

Piedmont Columbus Regional-Midtown Hospital
Columbus 4188985, Georgia 4197000 31901

Grady Health System- Grady Memorial Hospital
Decatur 4191124, Georgia 4197000 30030

Piedmont Fayette Hospital
Fayetteville 4194474, Georgia 4197000 10043

Memorial Health University Medical Center
Savannah 4221552, Georgia 4197000 31404

John D. Archbold Memorial Hospital
Thomasville 4226348, Georgia 4197000 31792

Swedish Hospital
Chicago 4887398, Illinois 4896861 60025

Mercy Hospital & Medical Center
Chicago 4887398, Illinois 4896861 60616

Northwestern Lake Forest Hospital
Lake Forest 4899012, Illinois 4896861 60045

Loyola University Medical Center
Maywood 4901514, Illinois 4896861 60153

Northwestern Medicine Central DuPage Hospital
Winfield 4916826, Illinois 4896861 60190

St. Vincent Hospital and Health Care Center, Inc.
Carmel 4255466, Indiana 4921868 46032

Richard L Roudebush Indianapolis VA
Indianapolis 4259418, Indiana 4921868 46202

Riverview Health
Noblesville 4924198, Indiana 4921868 46060

Our Lady of the Lakes Regional Medical Center
Baton Rouge 4315588, Louisiana 4331987 70808

Touro Infirmary
New Orleans 4335045, Louisiana 4331987 70112

Ochsner Clinic Foundation
New Orleans 4335045, Louisiana 4331987 70121

Slidell Memorial Hospital
Slidell 4341727, Louisiana 4331987 70458

University of Maryland
Baltimore 4347778, Maryland 4361885 21201

Mercy Medical Center
Baltimore 4347778, Maryland 4361885 21217

CalvertHealth Medical Center
Prince Frederick 4366159, Maryland 4361885 20678

University of Maryland St. Joseph Medical Center
Towson 4371582, Maryland 4361885 21204

Steward St. Elizabeth's Medical Center of Boston, Inc.
Boston 4930956, Massachusetts 6254926 02135

Cambridge Health Alliance
Cambridge 4931972, Massachusetts 6254926 02141

Charlton Memorial Hospital
Fall River 4936159, Massachusetts 6254926 02720

Lawrence General Hospital
Lawrence 4941720, Massachusetts 6254926 01841

Lowell General Hospital
Lowell 4942618, Massachusetts 6254926 01854

South Shore Hospital
South Weymouth 4951568, Massachusetts 6254926 02190

UMass Memorial Medical Center
Worcester 4956184, Massachusetts 6254926 01655

St. Joseph Mercy Hospital
Ann Arbor 4984247, Michigan 5001836 48106-0995

Huron Valley-Sinai Hospital
Commerce 4989420, Michigan 5001836 48382

Wayne Statue University/ Detroit Receiving Hospital
Detroit 4990729, Michigan 5001836 48201

Henry Ford Health System
Detroit 4990729, Michigan 5001836 48202

McLaren Health Care Corporation
Flint 4992982, Michigan 5001836 48532

Bronson Methodist Hospital
Kalamazoo 4997787, Michigan 5001836 49007

University of Mississippi Medical Center
Jackson 4431410, Mississippi 4436296 39216

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110

CarePoint Health Bayonne Medical Center
Bayonne 5095445, New Jersey 5101760 07002

Clara Maass Medical Center
Belleville 5095549, New Jersey 5101760 07109

Cooper University Hospital
Camden 4501018, New Jersey 5101760 08103

Hackensack Meridian Health - JFK Medical Center
Edison 5097529, New Jersey 5101760 08820

Trinitas Regional Medical Center
Elizabeth 5097598, New Jersey 5101760 07207

Englewood Health
Englewood 5097672, New Jersey 5101760 07631

Hunterdon Medical Center
Flemington 5098124, New Jersey 5101760 08822

CentraState Medical Center
Freehold 5098278, New Jersey 5101760 07728

Robert Wood Johnson University Hospital Hamilton
Hamilton 5098765, New Jersey 5101760 08690

Jersey City Medical Center
Jersey City 5099836, New Jersey 5101760 07302

Christ Hospital- Carepoint Health
Jersey City 5099836, New Jersey 5101760 07306

Monmouth Medical Center
Long Branch 5100619, New Jersey 5101760 07740

Atlantic Health System/ Morristown Medical Center
Morristown 5101427, New Jersey 5101760 07960

Jersey Shore University Medical Center
Neptune City 5101687, New Jersey 5101760 07753

Saint Peter's University Hospital
New Brunswick 5101717, New Jersey 5101760 08901

Saint Michael's Medical Center
Newark 5101798, New Jersey 5101760 07102

University Hospital
Newark 5101798, New Jersey 5101760 07103

Ocean Medical Center
Oakhurst 5102115, New Jersey 5101760 07755

Bayshore Medical Center
Red Bank 5103159, New Jersey 5101760 07701

The Valley Hospital
Ridgewood 5103269, New Jersey 5101760 07450

Atlantic Health System/Overlook Medical Center
Summit 5105127, New Jersey 5101760 07901

Holy Name Medical Center
Teaneck 5105262, New Jersey 5101760 07666

Capital Health
Trenton 5105496, New Jersey 5101760 08638

Virtua Health Voorhees Campus
Voorhees Township 5105860, New Jersey 5101760 08043

St. Peter's Hospital
Albany 5106834, New York 5128638 12208

Mount Sinai Queens
Astoria 5107464, New York 5128638 11102

Good Samaritan Hospital Medical Center
Bay Shore 5108169, New York 5128638 11706

Southside Hospital
Bay Shore 5108169, New York 5128638 11706

The Brooklyn Hospital Center
Brooklyn 5110302, New York 5128638 11201

Kingsbrook Jewish Medical Center
Brooklyn 5110302, New York 5128638 11203

University Hospital Brooklyn (SUNY Downstate)
Brooklyn 5110302, New York 5128638 11203

Woodhull Medical Center
Brooklyn 5110302, New York 5128638 11206

Kings County Hospital Center
Brooklyn 5110302, New York 5128638 11207

New York Harbor VA Medical Center
Brooklyn 5110302, New York 5128638 11209

Brookdale University Hospital and Medical Center
Brooklyn 5110302, New York 5128638 11212

Interfaith Medical Center
Brooklyn 5110302, New York 5128638 11213

NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn 5110302, New York 5128638 11215

Maimonides Medical Center
Brooklyn 5110302, New York 5128638 11219

NYU Langone Hospital - Brooklyn
Brooklyn 5110302, New York 5128638 11220

Mount Sinai Brooklyn
Brooklyn 5110302, New York 5128638 11234

New York City Health and Hospitals - Coney Island
Brooklyn 5110302, New York 5128638 11235

Kaleida Health System
Buffalo 5110629, New York 5128638 14203

Nassau University Medical Center
East Meadow 5115960, New York 5128638 11554

New York Presbyterian- Queens
Flushing 5117472, New York 5128638 11355

Glens Falls Hospital
Glens Falls 5118693, New York 5128638 12801

Queens Hospital Center
Jamaica 5122520, New York 5128638 11432

NYU Langone Health
New York 5128581, New York 5128638 10016

Hospital for Special Surgery
New York 5128581, New York 5128638 10021

New York City Health and New York City Health and Hospitals - Metropolitan- Metropolitan
New York 5128581, New York 5128638 10029

NewYork-Presyterian/Columbia University Irving Medical Center- Milstein Hospital
New York 5128581, New York 5128638 10032

New York City Health + Hospitals / Harlem
New York 5128581, New York 5128638 10037

New York Presbyterian Lower Manhattan Hospital
New York 5128581, New York 5128638 10038

Memorial Sloan-Kettering Cancer Center
New York 5128581, New York 5128638 10065

Mount Sinai South Nassau
Oceanside 5129603, New York 5128638 11572

Vassar Brothers Medical Center
Poughkeepsie 5132143, New York 5128638 12601

Rochester General Hospital
Rochester 5134086, New York 5128638 14621

St. Francis Hospital
Roslyn 5134415, New York 5128638 11576

Ellis Hospital
Schenectady 5136454, New York 5128638 12308

Staten Island University Hospital- Northwell Health (North Campus)
Staten Island 5139568, New York 5128638 10305

Stony Brook University Hospital/ Stony Brook Children's
Stony Brook 5139865, New York 5128638 11794

Lincoln Medical Center
The Bronx 5110266, New York 5128638 10451

St Barnabus Hospital
The Bronx 5110266, New York 5128638 10457

Montefiore Medical Center, Weiler Campus
The Bronx 5110266, New York 5128638 10461

Montefiore Health System Moses Medical Center
The Bronx 5110266, New York 5128638 10467-2490

Samaritan Hospital
Troy 5141502, New York 5128638 12180

UNC Hospitals
Chapel Hill 4460162, North Carolina 4482348 27599

Atrium Health- Carolinas Medical Center
Charlotte 4460243, North Carolina 4482348 28209

MetroHealth Medical Center
Cleveland 5150529, Ohio 5165418 44109

The Ohio State University College of Medicine
Columbus 4509177, Ohio 5165418 43210

Kettering Medical Center
Kettering 4515843, Ohio 5165418 45429

Saint Francis Hospital
Tulsa 4553433, Oklahoma 4544379 74136

St. Luke's Hospital - Bethlehem Campus
Bethlehem 5180225, Pennsylvania 6254927 18015

Mercy Catholic Medical Center - Fitzgerald Campus
Darby 4557485, Pennsylvania 6254927 19023

St Mary Medical Center
Langhorne 5197140, Pennsylvania 6254927 18940

Philadelphia VA Medical Center
Philadelphia 4560349, Pennsylvania 6254927 19104

Einstein Medical Center Philadelphia
Philadelphia 4560349, Pennsylvania 6254927 19141

Allegheny Health Network
Pittsburgh 5206379, Pennsylvania 6254927 15212

UPMC
Pittsburgh 5206379, Pennsylvania 6254927 15213

Roger Williams Medical Center
Providence 5224151, Rhode Island 5224323 02908

Kent Hospital
Warwick 5225507, Rhode Island 5224323 02886

St. Francis Hospital
Greenville 4580543, South Carolina 4597040 29607

Lexington Medical Center
West Columbia 4600541, South Carolina 4597040 29169

TriStar Centennial Medical Center
Nashville 4644585, Tennessee 4662168 37203

St. David's South Austin Medical Center
Austin 4671654, Texas 4736286 78705

Texas Health Presbyterian Hospital Dallas
Dallas 4684888, Texas 4736286 75231

Texas Department of Criminal Justice Hospital (Hospital Galveston)/University of Texas Medical Branch
Galveston 4692883, Texas 4736286 77555-0435

HCA Houston Healthcare West
Houston 4699066, Texas 4736286 77082

Covenant Medical Center
Lubbock 5525577, Texas 4736286 79410

Methodist Mansfield Medical Center
Mansfield 4709013, Texas 4736286 76063

Methodist Healthcare System of San Antonio, Ltd. LLP, dha, Methodist Hospital
San Antonio 4726206, Texas 4736286 78229

Saint Mark's Hospital
Salt Lake City 5780993, Utah 5549030 84124

Inova Fairfax Medical Campus
Falls Church 4758390, Virginia 6254928 22042

Henrico Doctors Hospital
Richmond 4781708, Virginia 6254928 23229

Carilion Medical Center
Roanoke 4782167, Virginia 6254928 24014

Overlake Hospital Medical Center
Bellevue 5786882, Washington 5815135 98004

University of Washington Medical Center- Montlake Campus
Seattle 5809844, Washington 5815135 98195

Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226

More Details

NCT ID: NCT04323761
Status: Approved for marketing
Sponsor: Gilead Sciences

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.