drugset / Trial / NCT05074433

A Study to Evaluate Efficacy and Safety of Casirivimab+Imdevimab (Monoclonal Antibodies) for Prevention of COVID-19 in Immunocompromised Adolescents and Adults

NCT05074433

Phase 3 Terminated 66 enrolled Regeneron Pharmaceuticals
RandomizedSequentialTriple-blindPrevention

Summary

The primary objective of the study is to evaluate the effect of casirivimab+imdevimab, compared with placebo, in preventing symptomatic SARS-CoV-2 infection in immunocompromised participants. The secondary objectives of the study are: * To evaluate the safety and tolerability of repeated SC injections of casirivimab+imdevimab in the study population * To characterize concentrations of casirivimab and imdevimab in serum over time * To assess the immunogenicity of casirivimab and imdevimab

Timeline

Start
2021-10-25
Primary completion
2022-05-18
Completion
2022-05-18

Drugs

EvaluationDrugModalityDoseRoute
Subject casirivimab Monoclonal antibody Subcutaneous
Subject imdevimab Monoclonal antibody Subcutaneous