Drugs in R&D · 2025
Safety, Tolerability, Pharmacokinetics, and Viral Pharmacodynamics of the Monoclonal Antibody Sotrovimab Administered via Intramuscular Injection in Participants with Early, Mild-to-Moderate COVID-19: A Randomized Clinical Trial.
Клиническое исследование II фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Gupta Anil, Perez-Rodríguez Maria Teresa, Gonzalez-Rojas Yaneicy, Ramgopal Moti, Free Almena, Han Jennifer, Moore Jennifer, Givens Naomi, Yates Phillip J, Walker Jill T, Connolly Mary Beth, Schnell Gretja, Imber Varsha, Anselm Rabia, Winograd Lindsay, Segal Scott, Harrison Stephen, Skingsley Andrew, Aldinger Melissa, Peppercorn Amanda, Moya Jaynier
Аннотация
BACKGROUND AND OBJECTIVES: New coronavirus disease 2019 (COVID-19) therapeutics, including intramuscular (IM) formulations, may increase patient access. In COMET-TAIL, sotrovimab 500 mg IM was non-inferior to 500 mg intravenous (IV) in reducing the risk of COVID-19 progression; however, 250 mg IM was associated with more hospitalizations, despite similar viral load (VL) reductions to 500 mg IM.
METHODS: COMET-PEAK was a randomized, three-part study to assess safety, tolerability, and viral pharmacodynamics of sotrovimab in adults with early, mild-to-moderate COVID-19. Parts B/C evaluated sotrovimab 500-mg IV infusion versus 500-mg or 250-mg IM injection. The primary objective was to compare virologic response of sotrovimab IM versus IV (mean area under the curve from day 1 to day 8 [AUCD1-8] of severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] VL); 90% confidence interval (CI) limits of 0.5-2.0 indicated equivalence.
RESULTS: Parts B/C included 167 and 157 participants, respectively. Median age range was 42-47 years, and approximately 50% of participants had one or more risk factor for severe disease. The primary objective was met: the ratio of geometric mean VL AUCD1-8 of sotrovimab IM versus IV was 1.04 (90% CI 0.98-1.09; Part B) and 1.02 (90% CI 0.94-1.11; Part C). No new safety signals emerged for sotrovimab; IM administration was well tolerated, with few injection-site reactions.
CONCLUSIONS: Both sotrovimab IM doses were equivalent to 500 mg IV with respect to SARS-CoV-2 VL change. IM administration was safe and well tolerated. The validity of VL as a biomarker for COVID-19 progression warrants further study.
CLINICAL TRIAL REGISTRATION: NCT04779879 (date of first registration: March 3, 2021), https://classic.
CLINICALTRIALS: gov/ct2/show/NCT04779879 .
METHODS: COMET-PEAK was a randomized, three-part study to assess safety, tolerability, and viral pharmacodynamics of sotrovimab in adults with early, mild-to-moderate COVID-19. Parts B/C evaluated sotrovimab 500-mg IV infusion versus 500-mg or 250-mg IM injection. The primary objective was to compare virologic response of sotrovimab IM versus IV (mean area under the curve from day 1 to day 8 [AUCD1-8] of severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] VL); 90% confidence interval (CI) limits of 0.5-2.0 indicated equivalence.
RESULTS: Parts B/C included 167 and 157 participants, respectively. Median age range was 42-47 years, and approximately 50% of participants had one or more risk factor for severe disease. The primary objective was met: the ratio of geometric mean VL AUCD1-8 of sotrovimab IM versus IV was 1.04 (90% CI 0.98-1.09; Part B) and 1.02 (90% CI 0.94-1.11; Part C). No new safety signals emerged for sotrovimab; IM administration was well tolerated, with few injection-site reactions.
CONCLUSIONS: Both sotrovimab IM doses were equivalent to 500 mg IV with respect to SARS-CoV-2 VL change. IM administration was safe and well tolerated. The validity of VL as a biomarker for COVID-19 progression warrants further study.
CLINICAL TRIAL REGISTRATION: NCT04779879 (date of first registration: March 3, 2021), https://classic.
CLINICALTRIALS: gov/ct2/show/NCT04779879 .