Study Details

OVERVIEW

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for COVID-19 (REDPINE)

PROTOCOL SUMMARY

The primary objective of this study is to evaluate whether remdesivir (RDV, GS-5734™) reduces the composite risk of death or invasive mechanical ventilation (IMV) through Day 29 in participants with severely reduced kidney function who are hospitalized for coronavirus disease 2019 (COVID-19).

Participation Requirements

Age

12 Years +

Sex

ALL

Healthy Volunteers

Medical Condition

COVID-19

Gender

N/A

Date

March 2021 - April 2022

Study Type

INTERVENTIONAL

Study Phase

PHASE3

Product

Remdesivir, RDV Placebo, Standard of Care

Eligibility Information

Inclusion Criteria

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) positive as determined by Polymerase Chain Reaction (PCR) or other commercially available or public health assay (eg, Nucleic Acid Amplification Test (NAAT) and antigen tests) in any respiratory specimen
Hospitalized for COVID-19
Weighing at least 40 kilograms (kg)
Oxygen (O2) saturation ≤ 94% on room air or requiring O2 supplement or Radiographic evidence of pulmonary infiltrates for COVID-19
Have either:
a) Severely reduced kidney function (estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m^2), including people with end-stage kidney disease (ESKD) requiring chronic dialysis
b) Ongoing acute kidney injury (AKI): defined as a 50% increase in serum creatinine (SCr) within a 48-hour period that is sustained (ie, requires confirmatory SCr) for ≥ 6 hours despite supportive care
The interval between COVID-19 symptoms onset and randomization is no more than 10 days

Exclusion Criteria

Received any investigational drug, RDV, or other antiviral treatment for COVID-19
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal
Invasive mechanical ventilation, noninvasive mechanical ventilation, extracorporeal membrane oxygenation (ECMO), or renal replacement therapy (RRT) for acute kidney injury (AKI)
Positive serum pregnancy test at screening for women of childbearing potential or currently breastfeeding
Known hypersensitivity to the study drug, metabolites, or formulation sulfobutylether-beta-cyclodextrin (SBECD)
Note: Other protocol defined Inclusion/Exclusion criteria may apply

Locations

Locations (63)

St. Vincent's Health System

Birmingham, Alabama, United States, 35205

UAB Hospital

Birmingham, Alabama, United States, 35294

Pulmonary Associates of Mobile, P.C.

Mobile, Alabama, United States, 36608

St. Joseph Hospital Eureka

Eureka, California, United States, 95501

Hoag Memorial Hospital Presbyterian, 16200 Sand Canyon Ave

Irvine, California, United States, 92618

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States, 92663

Sutter Medical Center Sacramento

Sacramento, California, United States, 95816

Torrance Memorial Medical Center

Torrance, California, United States, 90505

MedStar Health Research Institute

Washington, District of Columbia, United States, 20010

George Washington Medical Faculty Associates

Washington, District of Columbia, United States, 20037

North Florida/ South Georgia Veterans Health System

Gainesville, Florida, United States, 32608

Mayo Clinic Florida

Jacksonville, Florida, United States, 32224

Genesis Clinical Research

Tampa, Florida, United States, 33603

Northwestern Medicine Central DuPage Hospital

Winfield, Illinois, United States, 60190

Baptist Health Lexington

Lexington, Kentucky, United States, 40503

Tulane Medical Center, 2000 Canal St.

New Orleans, Louisiana, United States, 70112

Tulane Medical Center

New Orleans, Louisiana, United States, 70112

Wake Forest University Health Sciences

Bethesda, Maryland, United States, 20892

Holy Cross Hospital, 19801 Observation Dr

Germantown, Maryland, United States, 20876

Holy Cross Hospital

Silver Spring, Maryland, United States, 20910

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Newton-Wellesley Hospital

Newton, Massachusetts, United States, 02462

St. Clair Nephrology Research

Grosse Pointe Woods, Michigan, United States, 48236

G.V. (Sonny) Montgomery VAMC

Jackson, Michigan, United States, 39216

Mayo Clinic Hospital

Rochester, Minnesota, United States, 55902

Saint Michael's Medical Center

Newark, New Jersey, United States, 07102

University of New Mexico Hospital

Albuquerque, New Mexico, United States, 87131

Jacobi Medical Center

Bronx, New York, United States, 10461

New York - Presbyterian Hospital/Weill Cornell Medical Center

New York, New York, United States, 10065

Stony Brook University Hospital

Stony Brook, New York, United States, 11716

PMG Infectious Disease Consultants (administrative)

Portland, Oregon, United States, 92775

Temple University Hospital

Philadelphia, Pennsylvania, United States, 19140

Medical University of South Carolina

Charleston, South Carolina, United States, 92037

Houston Methodist Hospital

Houston, Texas, United States, 77030

Memorial Hermann Hospital at TMC

Houston, Texas, United States, 77030

VCU Health Medical Center

Richmond, Virginia, United States, 23298

Providence Regional Medical Center Everett

Everett, Washington, United States, 98201

Swedish Medical Center

Seattle, Washington, United States, 98122

Providence Health Care

Spokane, Washington, United States, 99204

Providence Health Care, 5633 N Lidgerwood

Spokane, Washington, United States, 99208

MultiCare Good Samaritan Hospital

Tacoma, Washington, United States, 98405

Hospital e Maternidade Celso Pierro/ Sociedade Campineira de Educacao e Instrucao/ PUC Campinas

Campinas, Brazil, 13060-904

Hospital Nossa Senhora das Gracas

Curitiba, Brazil, 80810-040

Hospital Alemao Oswaldo Cruz

Sao Paulo, Brazil, 01323-020

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

São José do Rio Preto, Brazil, 15090-000

Centro Hospitalar Cova da Beira EPE

Covilhã, Portugal, 6200-251

Hospital Nélio Mendonça,

Funchal, Portugal, 9000-514

Centro Hospitalar Lisboa Ocidental

Lisbon, Portugal, 1449-005

Centro Hospitalar do Porto - Hospital de Santo Antonio

Odivelas, Portugal, 2620-144

Centro Hospitalar de Vila Nova de Gaia

Vila Nova de Gaia, Portugal, 4434-502

George Regional Hospital

George, South Africa, 6529

Mediclinic Vergelegen

Somerset West, South Africa, 7130

Hospital Universitario Germans Trias I Pujol

Badalona, Spain, 08916

Hospital del Mar

Barcelona, Spain, 08003

Hospital Universitari de Bellvitge

Barcelona, Spain, 08907

Hospital Clinic de Barcelona

Barcelona, Spain, 8036

Hospital General Universitario de Elche

Elche, Spain, 3203

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Complejo Asistencial Universitario de Salamanca - H. Clinico

Salamanca, Spain, 37007

Hospital General Universitario de Valencia

Valencia, Spain, 46014

Barts Health NHS Trust, The Royal London Hospital

London, United Kingdom, E1 1BB

Kings College Hospital

London, United Kingdom, SE5 9RS

Imperial College Healthcare NHS Trust

London, United Kingdom, W12 0HS

Study to Evaluate the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for Coronavirus Disease 2019 (COVID-19) (REDPINE)