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
et al., JAMA, doi:10.1001/jama.2022.2832 (results published 12/4/21)
RCT 1,057 outpatients, 529 treated with sotrovimab, showing significantly lower hospitalization >24h or mortality with treatment.Efficacy is variant dependent. Lower efficacy for BA.1 [Liu, Sheward, VanBlargan], unlikely to be effective for BA.2 [Zhou]. US EUA has been revoked.
1.
Liu et al., bioRxiv, doi:10.1101/2021.12.14.472719,
Striking Antibody Evasion Manifested by the Omicron Variant of SARS-CoV-2,
https://www.biorxiv.org/content/10.1101/2021.12.14.472719.
2.
Sheward et al., bioRxiv, doi:10.1101/2021.12.19.473354,
Variable loss of antibody potency against SARS-CoV-2 B.1.1.529 (Omicron),
https://www.biorxiv.org/content/10.1101/2021.12.19.473354.
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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.
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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.
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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.
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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.
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| 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., 12/4/2021, Double Blind Randomized Controlled Trial, placebo-controlled, multiple countries, multiple regions, peer-reviewed, 68 authors, average treatment delay 2.6 days, trial NCT04545060 (COMET-ICE).
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