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
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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