sotrovimab (Xevudy; VIR-7831) (n=528) vs. placebo (n=529)
randomized controlled trial
Sotrovimab (VIR-7831, GSK4182136) as monotherapy
Intravenous infusion of sotrovimab 500 mg over 1 hour on day 1.
Placebo
Equal volume of saline placebo over 1 hour on day 1.
Patients were observed for approximately 2 hours after infusion.
COVID 19 outpatients
18 years of age and older with at least one of the following comorbidities: diabetes, obesity (BMI >30), chronic kidney disease, congestive heart failure, chronic obstructive pulmonary disease, or moderate to severe asthma, or were 55 years of age and older regardless of comorbidities. Participants must have a positive SARS-CoV-2 test result and oxygen saturation ≥94% on room air and have COVID-19 symptoms and be less than or equal to 5 days from onset of symptoms
Double-blind.
57 centers in 5 countries: US, Brazil, Spain, Canada, Peru.
*Warning! The spread of new Sars-Cov2 variants is constantly evolving, this study was performed in a different viral context than today, its results should be interpreted accordingly.* data reported in FDA emergency use authorization (EUA), results from interim analysis.
