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)
NCT ID: NCT04745351
Last Updated: 2023-05-12
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
249 participants
INTERVENTIONAL
2021-03-31
2022-05-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Remdesivir (RDV)
Participants will receive continued Standard of Care (SOC) therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg from Day 2 up to Day 5.
Remdesivir
Administered as Intravenous (IV) infusion once daily
Standard of Care
Standard of Care Treatment for COVID-19 Infection
Placebo
Participants will receive continued SOC therapy together with RDV matching placebo on Day 1 followed by RDV matching placebo from Day 2 up to Day 5.
RDV Placebo
Administered as IV saline once daily
Standard of Care
Standard of Care Treatment for COVID-19 Infection
Interventions
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Remdesivir
Administered as Intravenous (IV) infusion once daily
RDV Placebo
Administered as IV saline once daily
Standard of Care
Standard of Care Treatment for COVID-19 Infection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
12 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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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 D.C., District of Columbia, United States
George Washington Medical Faculty Associates
Washington D.C., 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
New York - Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Jacobi Medical Center
The Bronx, 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
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, , Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, , Brazil
Centro Hospitalar Cova da Beira EPE
Covilha, , 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
Countries
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References
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Sise ME, Santos JR, Goldman JD, Tuttle KR, Teixeira JP, Seibert AF, Koullias Y, Llewellyn J, Regan S, Zhao Y, Huang H, Hyland RH, Osinusi A, Winter H, Humeniuk R, Hulter HN, Gottlieb RL, Fusco DN, Birne R, Stancampiano FF, Libertin CR, Small CB, Plate M, McPhail MJ; REDPINE Investigators. Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 Pneumonia: A Randomized Clinical Trial. Clin Infect Dis. 2024 Nov 22;79(5):1172-1181. doi: 10.1093/cid/ciae333.
Grundeis F, Ansems K, Dahms K, Thieme V, Metzendorf MI, Skoetz N, Benstoem C, Mikolajewska A, Griesel M, Fichtner F, Stegemann M. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2023 Jan 25;1(1):CD014962. doi: 10.1002/14651858.CD014962.pub2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2020-005416-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DOH-27-012022-4779
Identifier Type: REGISTRY
Identifier Source: secondary_id
GS-US-540-5912
Identifier Type: -
Identifier Source: org_study_id
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