Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab
et al., NEJM, doi:10.1056/NEJMoa2107934 (news release 5/26/2021), NCT04545060, May 2021
Sotrovimab for COVID-19
44th treatment shown to reduce risk in
August 2022, now with p = 0.00054 from 28 studies, recognized in 42 countries.
Efficacy is variant dependent.
No treatment is 100% effective. Protocols
combine treatments.
6,200+ studies for
200+ 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, XBB, XBB.1.5, ХВВ.1.9.17, XBB.1.16, BQ.1.1.45, and CL.15. US EUA has been revoked.
Standard of Care (SOC) for COVID-19 in the study country,
the USA, is very poor with very low average efficacy for approved treatments8.
Only expensive, high-profit treatments were approved for early treatment. Low-cost treatments were excluded, reducing the probability of early treatment due to access and cost barriers, and eliminating complementary and synergistic benefits seen with many low-cost treatments.
|
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 |
1.
Liu et al., Striking Antibody Evasion Manifested by the Omicron Variant of SARS-CoV-2, bioRxiv, doi:10.1101/2021.12.14.472719.
2.
Sheward et al., Variable loss of antibody potency against SARS-CoV-2 B.1.1.529 (Omicron), bioRxiv, doi:10.1101/2021.12.19.473354.
3.
VanBlargan et al., An infectious SARS-CoV-2 B.1.1.529 Omicron virus escapes neutralization by several therapeutic monoclonal antibodies, bioRxiv, doi:10.1101/2021.12.15.472828.
4.
Haars et al., Prevalence of SARS-CoV-2 Omicron Sublineages and Spike Protein Mutations Conferring Resistance against Monoclonal Antibodies in a Swedish Cohort during 2022–2023, Microorganisms, doi:10.3390/microorganisms11102417.
5.
Pochtovyi et al., In Vitro Efficacy of Antivirals and Monoclonal Antibodies against SARS-CoV-2 Omicron Lineages XBB.1.9.1, XBB.1.9.3, XBB.1.5, XBB.1.16, XBB.2.4, BQ.1.1.45, CH.1.1, and CL.1, Vaccines, doi:10.3390/vaccines11101533.
6.
Zhou et al., SARS-CoV-2 Omicron BA.2 Variant Evades Neutralization by Therapeutic Monoclonal Antibodies, bioRxiv, doi:10.1101/2022.02.15.480166.
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).
Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab
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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