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).
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
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
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