COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04745351

Not reported

Not reported

2021-02-09

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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

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

2

Gilead Sciences

12

100

Brazil;Portugal;South Africa;Spain;United Kingdom;United States

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

249

Percentage of Participants With All-cause Death or Invasive Mechanical Ventilation (IMV) Through Day 29

None

Phase 3

[{"arm_notes": "", "treatment_id": 1099, "treatment_name": "Remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]