Intramuscular Versus Intravenous SARS-CoV-2 Neutralizing Antibody Sotrovimab for Treatment of COVID-19 (COMET-TAIL): A Randomized Non-inferiority Clinical Trial
et al., medRxiv, doi:10.1101/2023.03.21.23287410 (Preprint), COMET-TAIL, NCT04913675 (history)
, Intramuscular Versus Intravenous SARS-CoV-2 Neutralizing Antibody Sotrovimab for Treatment of COVID-19.., medRxiv, doi:10.1101/2023.03.21.23287410 (Preprint), COMET-TAIL, NCT04913675
RCT 982 high risk outpatients in the USA reporting that intramuscular sotrovimab was non-inferior to intravenous administration. Death and hospitalization was more frequent with intramuscular administration, without statistical significance due to the small number of events.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 US EUA has been revoked.
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, 401.1% higher, RR 5.01, p = 0.25, treatment 2 of 376 (0.5%), control 0 of 378 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm).
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risk of hospitalization, 101.1% higher, RR 2.01, p = 0.20, treatment 10 of 376 (2.7%), control 5 of 378 (1.3%).
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risk of progression, 503.2% higher, RR 6.03, p = 0.07, treatment 6 of 376 (1.6%), control 1 of 378 (0.3%), progression to severe.
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| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
Shapiro et al., 24 Mar 2023, Randomized Controlled Trial, USA, preprint, 28 authors, this trial compares with another treatment - results may be better when compared to placebo, trial NCT04913675 (history) (COMET-TAIL).
Contact:
akohli@azliver.com, lgaffney@vir.bio.
Intramuscular Versus Intravenous SARS-CoV-2 Neutralizing Antibody Sotrovimab for Treatment of COVID-19 (COMET-TAIL): A Randomized Non-inferiority Clinical Trial
doi:10.1101/2023.03.21.23287410
Sotrovimab 500-mg IM was non-inferior to sotrovimab 500-mg IV for treatment of mild/moderate COVID-19 in high-risk patients, measured by all-cause hospitalization >24h or death through day 29, and was well-tolerated. Sotrovimab IM should provide easier outpatient access to COVID-19 treatment.
Funding The study was supported by Vir Biotechnology, Inc. in collaboration with GSK.
Author Contributions PSP, DKH, EA, WWY, EM, JES, DA, SC, and AP conceptualized and designed the study. All authors acquired, analyzed and/or interpreted the data. DI and DC conducted the statistical analyses. AK, LAG, and DI accessed and verified the data. All authors drafted the manuscript and critically reviewed and revised the manuscript for important intellectual content. All authors had full access to all the data in the study, take responsibility for the accuracy of the analysis, and had authority over manuscript preparation and the decision to submit the manuscript for publication.
Conflict of Interest Disclosures
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