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All Studies   Meta Analysis    Recent:   

Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab

Gupta et al., NEJM, doi:10.1056/NEJMoa2107934 (news release 5/26/2021), NCT04545060
May 2021  
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Mortality 67% Improvement Relative Risk Ventilation 80% ICU admission 91% Hospitalization 81% Hospitalization (b) 86% primary Sotrovimab  Gupta et al.  EARLY TREATMENT  DB RCT Is early treatment with sotrovimab beneficial for COVID-19? Double-blind RCT 583 patients in the USA (August 2020 - March 2021) Lower hospitalization with sotrovimab (p=0.00071) c19early.org Gupta et al., NEJM, May 2021 Favorssotrovimab Favorscontrol 0 0.5 1 1.5 2+
Sotrovimab for COVID-19
41st treatment shown to reduce risk in May 2023
 
*, now with p = 0.003 from 24 studies, recognized in 38 countries. Efficacy is variant dependent.
Lower risk for ICU admission and hospitalization.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,400+ studies for 79 treatments. c19early.org
Interim results from the COMET-ICE trial showing significantly lower hospitalization with treatment. NCT04545060 (history).
Efficacy is variant dependent. In Vitro studies predict lower efficacy for BA.11-3, BA.4, BA.54, XBB.1.9.3, XBB.1.5.24, XBB.2.9, CH.1.15, and no efficacy for BA.26, ХВВ.1.9.1, XBB.1.16, BQ.1.1.45, and CL.15. US EUA has been revoked.
risk of death, 66.6% lower, RR 0.33, p = 1.00, treatment 0 of 291 (0.0%), control 1 of 292 (0.3%), NNT 292, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of mechanical ventilation, 80.0% lower, RR 0.20, p = 0.50, treatment 0 of 291 (0.0%), control 2 of 292 (0.7%), NNT 146, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of ICU admission, 90.9% lower, RR 0.09, p = 0.06, treatment 0 of 291 (0.0%), control 5 of 292 (1.7%), NNT 58, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of hospitalization, 80.9% lower, RR 0.19, p < 0.001, treatment 4 of 291 (1.4%), control 21 of 292 (7.2%), NNT 17.
risk of hospitalization, 85.7% lower, RR 0.14, p < 0.001, treatment 3 of 291 (1.0%), control 21 of 292 (7.2%), NNT 16, >24hrs, primary outcome.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Gupta et al., 26 May 2021, Double Blind Randomized Controlled Trial, USA, preprint, 22 authors, study period 27 August, 2020 - 4 March, 2021, trial NCT04545060 (history).
This PaperSotrovimabAll
Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab
M.D Anil Gupta, M.D Yaneicy Gonzalez-Rojas, M.D Erick Juarez, M.D Manuel Crespo Casal, M.D Jaynier Moya, M.D Diego R Falci, Ph.D Elias Sarkis, M.D Joel Solis, M.D Hanzhe Zheng, Ph.D Nicola Scott, M.Sc Andrea L Cathcart, Ph.D Christy M Hebner, Ph.D Jennifer Sager, Ph.D Erik Mogalian, Ph.D Craig Tipple, Ph.D Amanda Peppercorn, M.D Elizabeth Alexander, M.D Phillip S Pang, Ph.D Almena Free, M.D Cynthia Brinson, M.D Melissa Aldinger, Pharm.D Adrienne E Shapiro
New England Journal of Medicine, doi:10.1056/nejmoa2107934
BACKGROUND Coronavirus disease 2019 (Covid-19) disproportionately results in hospitalization or death in older patients and those with underlying conditions. Sotrovimab is a pan-sarbecovirus monoclonal antibody that was designed to prevent progression of Covid-19 in high-risk patients early in the course of disease. METHODS CONCLUSIONS Among high-risk patients with mild-to-moderate Covid-19, sotrovimab reduced the risk of disease progression. No safety signals were identified. (Funded by Vir Biotechnology and GlaxoSmithKline; COMET-ICE ClinicalTrials.gov number, NCT04545060.
against the non-receptor-binding motif, which does not directly block the ACE2 receptor interaction, can be clinically therapeutic, and thus the results suggest a role for other receptors. 27 Second, because sotrovimab has potent effector function, the efficacy and absence of safety signals suggest that effector function is neither detrimental nor associated with antibody-dependent enhancement. 26 In fact, preclinical models of Covid-19 suggest that the potent effector function of this agent may be beneficial. 13, 14 The results of this interim analysis of COMET-ICE indicate that sotrovimab can be a therapeutic agent for outpatients with Covid-19. Notably, a 500-mg dose may also permit intramuscular administration, which may increase the convenience of and access to therapeutic antibody agents for patients with Covid-19. Studies are currently under way to evaluate this route of administration. Given its in vitro activity against variants of interest and concern, 14 as well as its ability to neutralize other sarbecoviruses, we speculate that sotrovimab has the potential to remain therapeutically active even as SARS-CoV-2 continues to evolve. Supported by Vir Biotechnology and GlaxoSmithKline. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.
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