Official Title
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
Brief 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).

Terminated
COVID-19

Drug: Remdesivir

Administered as Intravenous (IV) infusion once daily
Other Name: Array

Drug: RDV Placebo

Administered as IV saline once daily

Drug: Standard of Care

Standard of Care Treatment for COVID-19 Infection

Eligibility Criteria

Key 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

Key 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

Eligibility Gender
All
Eligibility Age
Minimum: 12 Years ~ Maximum: N/A
Countries
Brazil
Portugal
South Africa
Spain
United Kingdom
United States
Locations

St. Vincent's Health System
Birmingham, Alabama, United States

UAB Hospital
Birmingham, Alabama, United States

Pulmonary Associates of Mobile, P.C.
Mobile, Alabama, United States

St. Joseph Hospital Eureka
Eureka, California, United States

Hoag Memorial Hospital Presbyterian, 16200 Sand Canyon Ave
Irvine, California, United States

Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States

Sutter Medical Center Sacramento
Sacramento, California, United States

Torrance Memorial Medical Center
Torrance, California, United States

MedStar Health Research Institute
Washington, District of Columbia, United States

George Washington Medical Faculty Associates
Washington, District of Columbia, United States

North Florida/ South Georgia Veterans Health System
Gainesville, Florida, United States

Mayo Clinic Florida
Jacksonville, Florida, United States

Genesis Clinical Research
Tampa, Florida, United States

Northwestern Medicine Central DuPage Hospital
Winfield, Illinois, United States

Baptist Health Lexington
Lexington, Kentucky, United States

Tulane Medical Center, 2000 Canal St.
New Orleans, Louisiana, United States

Tulane Medical Center
New Orleans, Louisiana, United States

Wake Forest University Health Sciences
Bethesda, Maryland, United States

Holy Cross Hospital, 19801 Observation Dr
Germantown, Maryland, United States

Holy Cross Hospital
Silver Spring, Maryland, United States

Massachusetts General Hospital
Boston, Massachusetts, United States

Newton-Wellesley Hospital
Newton, Massachusetts, United States

St. Clair Nephrology Research
Grosse Pointe Woods, Michigan, United States

G.V. (Sonny) Montgomery VAMC
Jackson, Michigan, United States

Mayo Clinic Hospital
Rochester, Minnesota, United States

Saint Michael's Medical Center
Newark, New Jersey, United States

University of New Mexico Hospital
Albuquerque, New Mexico, United States

Jacobi Medical Center
Bronx, New York, United States

New York - Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, United States

Stony Brook University Hospital
Stony Brook, New York, United States

PMG Infectious Disease Consultants (administrative)
Portland, Oregon, United States

Temple University Hospital
Philadelphia, Pennsylvania, United States

Medical University of South Carolina
Charleston, South Carolina, United States

Houston Methodist Hospital
Houston, Texas, United States

Memorial Hermann Hospital at TMC
Houston, Texas, United States

VCU Health Medical Center
Richmond, Virginia, United States

Providence Regional Medical Center Everett
Everett, Washington, United States

Swedish Medical Center
Seattle, Washington, United States

Providence Health Care
Spokane, Washington, United States

Providence Health Care, 5633 N Lidgerwood
Spokane, Washington, United States

MultiCare Good Samaritan Hospital
Tacoma, Washington, United States

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

Hospital Nossa Senhora das Gracas
Curitiba, Brazil

Hospital Alemao Oswaldo Cruz
Sao Paulo, Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, Brazil

Centro Hospitalar Cova da Beira EPE
Covilhã, Portugal

Hospital Nélio Mendonça,
Funchal, Portugal

Centro Hospitalar Lisboa Ocidental
Lisbon, Portugal

Centro Hospitalar do Porto - Hospital de Santo Antonio
Odivelas, Portugal

Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia, Portugal

George Regional Hospital
George, South Africa

Mediclinic Vergelegen
Somerset West, South Africa

Hospital Universitario Germans Trias I Pujol
Badalona, Spain

Hospital del Mar
Barcelona, Spain

Hospital Universitari de Bellvitge
Barcelona, Spain

Hospital Clinic de Barcelona
Barcelona, Spain

Hospital General Universitario de Elche
Elche, Spain

Hospital Universitario 12 de Octubre
Madrid, Spain

Complejo Asistencial Universitario de Salamanca - H. Clinico
Salamanca, Spain

Hospital General Universitario de Valencia
Valencia, Spain

Barts Health NHS Trust, The Royal London Hospital
London, United Kingdom

Kings College Hospital
London, United Kingdom

Imperial College Healthcare NHS Trust
London, United Kingdom

Gilead Study Director, Study Director
Gilead Sciences

Gilead Sciences
NCT Number
MeSH Terms
COVID-19
Remdesivir