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0 0.5 1 1.5 2+ Mortality -401% Improvement Relative Risk Hospitalization -101% Progression -503% Shapiro et al. NCT04913675 COMET-TAIL Sotrovimab RCT EARLY Is early treatment with sotrovimab beneficial for COVID-19? RCT 982 patients in the USA Trial compares with intravenous sotrovimab Higher mortality (p=0.25) and hospitalization (p=0.2), not stat. sig. Shapiro et al., medRxiv, doi:10.1101/2023.03.21.23287410 Favors sotrovimab Favors intravenous ..

Intramuscular Versus Intravenous SARS-CoV-2 Neutralizing Antibody Sotrovimab for Treatment of COVID-19 (COMET-TAIL): A Randomized Non-inferiority Clinical Trial

Shapiro et al., medRxiv, doi:10.1101/2023.03.21.23287410 (Preprint), COMET-TAIL, NCT04913675 (history)
Shapiro et al., 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
Mar 2023   Source   PDF  
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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 US EUA has been revoked.
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).
risk of hospitalization, 101.1% higher, RR 2.01, p = 0.20, treatment 10 of 376 (2.7%), control 5 of 378 (1.3%).
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.
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).
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Intramuscular Versus Intravenous SARS-CoV-2 Neutralizing Antibody Sotrovimab for Treatment of COVID-19 (COMET-TAIL): A Randomized Non-inferiority Clinical Trial
Adrienne E Shapiro, Elias Sarkis, Jude Acloque, Almena Free, Yaneicy Gonzalez-Rojas, Rubaba Hussain, Erick Juarez, Jaynier Moya, Naval Parikh, David Inman, Deborah Cebrik, Ahmed Nader, Nadia Noormohamed, Qianwen Wang, Andrew Skingsley, Daren Austin, Amanda Peppercorn, Maria L Agostini, Sergio Parra, Sophia Chow, Erik Mogalian, Phillip S Pang, David K Hong, Jennifer E Sager, Wendy W Yeh, Vir Biotechnology, Inc Elizabeth L Alexander, Dr Leah A Gaffney, Dr Anita Kohli
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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Zheng, Green, Tazare, Comparative effectiveness of sotrovimab and molnupiravir for prevention of severe covid-19 outcomes in patients in the community: observational cohort study with the OpenSAFELY platform, BMJ
Zheng, Tazare, Nab, Comparative effectiveness of Paxlovid versus sotrovimab and molnupiravir for preventing severe COVID-19 outcomes in nonhospitalised patients: observational cohort study using the OpenSAFELY platform, medRxiv, doi:10.1101/2023.01.20.23284849
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