Endpoint events occurred in 3 of 291 participants (1%) in the sotrovimab arm and 21 of 292 participants (7%) in the placebo arm (P = 0.002), resulting in a 6% absolute reduction and an 85% relative reduction in hospitalizations or death among the sotrovimab recipients compared to the placebo recipients. The primary endpoint was the proportion of hospitalized participants ( ≥24 hours) or who died from any cause by Day 29. A total of 583 participants were randomized to receive sotrovimab 500 mg IV (n = 291) or placebo (n = 292). The data that support the EUA for sotrovimab came from the Phase 3 COMET-ICE trial, which included outpatients with mild to moderate COVID-19 who were at high risk for progression to severe disease and/or hospitalization. FDA's EUA issued on May 26, 2021, allows for Sotrovimab to be distributed and administered as a 500-milligram single dose intravenously by health care providers. The Companies published ' A Detailed Guide for the Use of Sotrovimab' in July 2021. Vir Biotechnology and GSK are advancing Sotrovimab (VIR-7831) due to their collaboration to research and develop solutions. Sotrovimab, sold under the brand name Xevudy. This antibody therapy binds to an epitope on SARS-CoV-2 shared with SARS-CoV-1 (SARS). In preclinical trials, the antibody has shown the ability to neutralize the SARS-CoV-2 live virus by binding to an epitope on SARS-CoV-2 shared with SARS-CoV-1, indicating that the epitope is highly conserved, which may make it more difficult for escape mutants to develop. Sotrovimab ( Xevudy®) (VIR-7831, GSK4182136) is a fully human anti-SARS-CoV-2 monoclonal antibody selected based on its potential to neutralize the betacoronavirus in vitro, kill infected cells, provide a high barrier to resistance, and achieve high concentrations in the lungs (one of the important sites of infection).
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