CD2H COVID-19

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 Genders: 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, Alabama 35294

Banner- University Medical Center Phoenix
Phoenix, Arizona 85006

Community Regional Medical Centers (CRMC)
Fresno, California 93721

St. Jude Medical Center
Fullerton, California 92835

Scripps Memorial Hospital La Jolla
La Jolla, California 92037

Long Beach Memorial Medical Center
Long Beach, California 90806

Huntington Hospital
Pasadena, California 91105

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

Los Robles Regional Medical Center
Thousand Oaks, California 91360

PIH Health Whittier Hospital
Whittier, California 90602

The Medical Center Of Aurora
Aurora, Colorado 80012

Rose Medical Center
Denver, Colorado 80220

Swedish Medical Center
Englewood, Colorado 80113

Greenwich Hospital
Greenwich, Connecticut 06830

Middlesex Health
Middletown, Connecticut 64587

The Hospital of Central Connecticut
New Britain, Connecticut 06052

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

George Washington University Hospital
Washington, District of Columbia 20037

Aventura Hospital and Medical Center
Aventura, Florida 33180

Lawnwood Regional Medical Center
Fort Pierce, Florida 34982

Memorial Regional Hospital
Hollywood, Florida 33021

Mayo Clinic in Florida
Jacksonville, Florida 32224

Mount Sinai Medical Center
Miami Beach, Florida 33140

AdventHealth Orlando, Investigational Drug Services
Orlando, Florida 32803

Sarasota Memorial Hospital
Sarasota, Florida 34239

Piedmont Atlanta Hospital
Atlanta, Georgia 30309

Wellstar Atlanta Medical Center
Atlanta, Georgia 30312

Piedmont Columbus Regional-Midtown Hospital
Columbus, Georgia 31901

Grady Health System- Grady Memorial Hospital
Decatur, Georgia 30030

Piedmont Fayette Hospital
Fayetteville, Georgia 10043

Memorial Health University Medical Center
Savannah, Georgia 31404

John D. Archbold Memorial Hospital
Thomasville, Georgia 31792

Swedish Hospital
Chicago, Illinois 60025

Mercy Hospital & Medical Center
Chicago, Illinois 60616

Northwestern Lake Forest Hospital
Lake Forest, Illinois 60045

Loyola University Medical Center
Maywood, Illinois 60153

Northwestern Medicine Central DuPage Hospital
Winfield, Illinois 60190

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

Richard L Roudebush Indianapolis VA
Indianapolis, Indiana 46202

Riverview Health
Noblesville, Indiana 46060

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

Touro Infirmary
New Orleans, Louisiana 70112

Ochsner Clinic Foundation
New Orleans, Louisiana 70121

Slidell Memorial Hospital
Slidell, Louisiana 70458

University of Maryland
Baltimore, Maryland 21201

Mercy Medical Center
Baltimore, Maryland 21217

CalvertHealth Medical Center
Prince Frederick, Maryland 20678

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

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

Cambridge Health Alliance
Cambridge, Massachusetts 02141

Charlton Memorial Hospital
Fall River, Massachusetts 02720

Lawrence General Hospital
Lawrence, Massachusetts 01841

Lowell General Hospital
Lowell, Massachusetts 01854

South Shore Hospital
South Weymouth, Massachusetts 02190

UMass Memorial Medical Center
Worcester, Massachusetts 01655

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

Huron Valley-Sinai Hospital
Commerce, Michigan 48382

Wayne Statue University/ Detroit Receiving Hospital
Detroit, Michigan 48201

Henry Ford Health System
Detroit, Michigan 48202

McLaren Health Care Corporation
Flint, Michigan 48532

Bronson Methodist Hospital
Kalamazoo, Michigan 49007

University of Mississippi Medical Center
Jackson, Mississippi 39216

Washington University School of Medicine
Saint Louis, Missouri 63110

CarePoint Health Bayonne Medical Center
Bayonne, New Jersey 07002

Clara Maass Medical Center
Belleville, New Jersey 07109

Cooper University Hospital
Camden, New Jersey 08103

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

Trinitas Regional Medical Center
Elizabeth, New Jersey 07207

Englewood Health
Englewood, New Jersey 07631

Hunterdon Medical Center
Flemington, New Jersey 08822

CentraState Medical Center
Freehold, New Jersey 07728

Robert Wood Johnson University Hospital Hamilton
Hamilton, New Jersey 08690

Jersey City Medical Center
Jersey City, New Jersey 07302

Christ Hospital- Carepoint Health
Jersey City, New Jersey 07306

Monmouth Medical Center
Long Branch, New Jersey 07740

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

Jersey Shore University Medical Center
Neptune, New Jersey 07753

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

Saint Michael's Medical Center
Newark, New Jersey 07102

University Hospital
Newark, New Jersey 07103

Ocean Medical Center
Oakhurst, New Jersey 07755

Bayshore Medical Center
Red Bank, New Jersey 07701

The Valley Hospital
Ridgewood, New Jersey 07450

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

Holy Name Medical Center
Teaneck, New Jersey 07666

Capital Health
Trenton, New Jersey 08638

Virtua Health Voorhees Campus
Voorhees, New Jersey 08043

St. Peter's Hospital
Albany, New York 12208

Mount Sinai Queens
Astoria, New York 11102

Good Samaritan Hospital Medical Center
Bay Shore, New York 11706

Southside Hospital
Bay Shore, New York 11706

Lincoln Medical Center
Bronx, New York 10451

St Barnabus Hospital
Bronx, New York 10457

Montefiore Medical Center, Weiler Campus
Bronx, New York 10461

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

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

Nassau University Medical Center
East Meadow, New York 11554

New York Presbyterian- Queens
Flushing, New York 11355

Glens Falls Hospital
Glens Falls, New York 12801

Queens Hospital Center
Jamaica, New York 11432

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

Mount Sinai South Nassau
Oceanside, New York 11572

Vassar Brothers Medical Center
Poughkeepsie, New York 12601

Rochester General Hospital
Rochester, New York 14621

St. Francis Hospital
Roslyn, New York 11576

Ellis Hospital
Schenectady, New York 12308

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

Samaritan Hospital
Troy, New York 12180

UNC Hospitals
Chapel Hill, North Carolina 27599

Atrium Health- Carolinas Medical Center
Charlotte, North Carolina 28209

MetroHealth Medical Center
Cleveland, Ohio 44109

The Ohio State University College of Medicine
Columbus, Ohio 43210

Kettering Medical Center
Kettering, Ohio 45429

Saint Francis Hospital
Tulsa, Oklahoma 74136

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

Mercy Catholic Medical Center - Fitzgerald Campus
Darby, Pennsylvania 19023

St Mary Medical Center
Langhorne, Pennsylvania 18940

Philadelphia VA Medical Center
Philadelphia, Pennsylvania 19104

Einstein Medical Center Philadelphia
Philadelphia, Pennsylvania 19141

Allegheny Health Network
Pittsburgh, Pennsylvania 15212

UPMC
Pittsburgh, Pennsylvania 15213

Roger Williams Medical Center
Providence, Rhode Island 02908

Kent Hospital
Warwick, Rhode Island 02886

St. Francis Hospital
Greenville, South Carolina 29607

Lexington Medical Center
West Columbia, South Carolina 29169

TriStar Centennial Medical Center
Nashville, Tennessee 37203

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

Texas Health Presbyterian Hospital Dallas
Dallas, Texas 75231

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

HCA Houston Healthcare West
Houston, Texas 77082

Covenant Medical Center
Lubbock, Texas 79410

Methodist Mansfield Medical Center
Mansfield, Texas 76063

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

Saint Mark's Hospital
Salt Lake City, Utah 84124

Inova Fairfax Medical Campus
Falls Church, Virginia 22042

Henrico Doctors Hospital
Richmond, Virginia 23229

Carilion Medical Center
Roanoke, Virginia 24014

Overlake Hospital Medical Center
Bellevue, Washington 98004

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

Medical College of Wisconsin
Milwaukee, Wisconsin 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.