meta|Evidence - COVID-19
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sotrovimab (Xevudy; VIR-7831) (n=184) vs. placebo (n=183)
randomized controlled trial low risk of bias
VIR-7831 Sotrovimab
Standard of care plus single intravenous dose of sotrovimab 500mg over 60 minutes as soon as possible after randomisation.
Placebo
Standard of care plus placebo (0.9% sodium chloride).
Randomisation allocation was 2:1:2:1 to sotrovimab, matching placebo for sotrovimab, BRII-196 plus BRII-198, or matching placebo for BRII-196 plus BRII-198. The concurrent placebo groups were pooled for analyses, resulting in approximately a 1:1:1 allocation ofsotrovimab to BRII-196 plus BRII-198 to placebo. All patients received remdesivir. Other treatments for COVID-19, including oxygen, respiratory support, and corticosteroids, were administered at the discretion of the treating clinician per local standard of care.
COVID 19 hospitalized
Patients with laboratory-confirmed SARS-CoV-2 infection and COVID-19 symptoms for up to 12 days. Patients were eligible for enrolment if they were receiving no oxygen therapy or standard oxygen therapy via a nasal cannula or mask, but were excluded if they were receiving high-flow oxygen via nasal cannula, non-invasive ventilation, or invasive mechanical ventilation, or met any of the other criteria for acute organ failure or major extrapulmonary manifestations of COVID-19.
Double-blind.
43 hospitals in the USA, Denmark, Switzerland, and Poland.
*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.* Prematurely discontinued for futility (based on pulmonary and pulmonary-plus ordinal outcome scale at day 5) after enrollment of 300 patients.
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