GlaxoSmithKline plc and Vir Biotechnology, Inc. announced headline data from the randomised, multi-centre, open-label COMET-TAIL phase III trial, which achieved its primary endpoint, demonstrating intramuscular (IM) administration of sotrovimab was non-inferior to intravenous (IV) administration for the early treatment of mild-to-moderate Covid-19 in high-risk, non-hospitalised adults and adolescents (12 years of age and older).
The COMET-TAIL phase III trial was designed to evaluate the efficacy, safety, and tolerability of sotrovimab delivered via IM administration compared to IV administration in high-risk patients up to seven days after symptom onset. In the IM administration (500mg) arm of the trial, there was a 2.7% rate of progression to hospitalisation for more than 24 hours or death through Day 29 of the trial, compared to 1.3% in the IV administration arm (also 500mg). The adjusted difference between the IM and IV arms of the trial was 1.07% with a 95% confidence interval (CI) of -1.25% to 3.39%. The upper bound of the 95% CI is within the predetermined 3.5% non-inferiority margin set for the trial
