Status:
TERMINATED
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)
Lead Sponsor:
Gilead Sciences
Conditions:
COVID-19
Eligibility:
All Genders
12+ years
Phase:
PHASE3
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 s...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
March 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2022
Estimated Enrollment :
249 Patients enrolled
Trial Details
Trial ID
NCT04745351
Start Date
March 31 2021
End Date
May 24 2022
Last Update
May 12 2023
Active Locations (63)
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1
St. Vincent's Health System
Birmingham, Alabama, United States, 35205
2
UAB Hospital
Birmingham, Alabama, United States, 35294
3
Pulmonary Associates of Mobile, P.C.
Mobile, Alabama, United States, 36608
4
St. Joseph Hospital Eureka
Eureka, California, United States, 95501