Intravenous remdesivir
Intravenous remdesivir (200 mg on day 1 and 100 mg on days 2 and 3).
Placebo
COVID 19 outpatients
Eligible patients were 12 years of age or older and had at least one preexisting risk factor for progression to severe Covid-19 or were 60 years of age or older, regardless of whether they had other risk factors. Risk factors included hypertension, cardiovascular or cerebrovascular disease, diabetes mellitus, obesity (a body-mass index [BMI; the weight in kilograms divided by the square of the height in meters] of ≥30), immune compromise, chronic mild or moderate kidney disease, chronic liver disease, chronic lung disease,current cancer, or sickle cell disease.
Double-blind.
64 sites in the US, Spain, Denmark, UK.
The primary efficacy end point was initially a composite of hospitalization for any cause or death from any cause by day 14 and was modified on January 14, 2021, in response to comments from the Food and Drug Administration; trial blinding was maintained. No interim statistical analyses were performed.
On April 6, 2021, an orderly closure of trial enrollment was announced by the sponsor because of administrative reasons related to a decrease in the incidence of SARS-CoV-2 infections, ethical concerns regarding assigning patients to placebo in the context of increased access to emergency-use–authorized treatments such as monoclonal antibodies, and increasing vaccination rates among high-risk persons.
