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0 0.5 1 1.5 2+ Mortality 80% Improvement Relative Risk Ventilation 89% Progression 75% Hospitalization >24hrs or.. 79% primary c19early.com/v Gupta et al. NCT04545060 COMET-ICE Sotrovimab RCT EARLY Favors sotrovimab Favors control
Gupta, 1,057 patient sotrovimab early treatment RCT: 89% lower ventilation [p=0.12], 75% lower progression [p=0.0004], and 79% lower combined mortality/hospitalization [p=0.0004] https://c19p.org/gupta4
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Effect of Sotrovimab on Hospitalization or Death Among High-risk Patients With Mild to Moderate COVID-19
Gupta et al., JAMA, doi:10.1001/jama.2022.2832 (results published 12/4/21), COMET-ICE, NCT04545060 (history)
4 Dec 2021    Source   PDF   Share   Tweet
RCT 1,057 outpatients, 529 treated with sotrovimab, showing significantly lower hospitalization >24h or mortality with treatment.
Efficacy is variant dependent. In Vitro studies predict lower efficacy for BA.1 [Liu, Sheward, VanBlargan] and a lack of efficacy for BA.2 [Zhou]. US EUA has been revoked.
risk of death, 80.0% lower, RR 0.20, p = 0.50, treatment 0 of 528 (0.0%), control 2 of 529 (0.4%), NNT 264, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), day 29.
risk of mechanical ventilation, 88.9% lower, RR 0.11, p = 0.12, treatment 0 of 528 (0.0%), control 4 of 529 (0.8%), NNT 132, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), day 29.
risk of progression, 75.0% lower, RR 0.25, p < 0.001, treatment 7 of 528 (1.3%), control 28 of 529 (5.3%), NNT 25, day 29.
risk of hospitalization >24hrs or death, 79.0% lower, RR 0.21, p < 0.001, treatment 6 of 528 (1.1%), control 30 of 529 (5.7%), NNT 22, day 29, ITT, primary outcome.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Conflicts of interest: research funding from the drug patent holder, employee of the drug patent holder.
Gupta et al., 4 Dec 2021, Double Blind Randomized Controlled Trial, placebo-controlled, multiple countries, peer-reviewed, 68 authors, average treatment delay 2.6 days, trial NCT04545060 (history) (COMET-ICE).
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