Calendario›VIR›sotrovimab

sotrovimab

Intramuscular and Intravenous VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19.

Ensayo de Vir Biotechnology, Inc. en COVID-19.

Más ensayos de: COVID-19.

Fase

Fase 3

Estado

Interrumpido

Participantes

1.065

previstos

Centros

50

Fin del objetivo primario

jul 2022

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en jun 2021.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «The safety sub-study was discontinued early in the context of evolving variants with increased fold changes in the in vitro half maximal inhibitory concentration (IC50) and uncertainty in the clinical relevance of these changes».

Qué mide

Main Study: Percentage of Participants Who Had Progression of Coronavirus Disease 2019 (COVID-19) Through Day 29 by Hospitalization >24 Hours or Death Due to Any Cause (Weekly and Daily Imputation) (del registro, en inglés) (hasta el dia 29)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe COMET-TAIL main study evaluated efficacy, safety, and tolerability of IM sotrovimab versus IV sotrovimab in high-risk patients for the treatment of mild/moderate COVID-19. In the safety substudy, the aim was to evaluate the safety and tolerability of sotrovimab across a single ascending dose level and over different infusion times when given for the treatment of mild/moderate COVID-19 to participants at high risk of disease progression Main study was completed successfully. The safety sub-study was discontinued early in the context of evolving variants with increased fold changes in the in vitro half maximal inhibitory concentration (IC50) and uncertainty in the clinical relevance of these changes.

Más ensayos de VIR

Todos los de VIR, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04913675), actualizada en feb 2024.