A Study to Evaluate Efficacy and Safety of Casirivimab+Imdevimab (Monoclonal Antibodies) for Prevention of COVID-19 in Immunocompromised Adolescents and Adults
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
Outcome
Missed primary endpoint
Stopped: “Emerging SARS-CoV2 variants impacting susceptibility to study drug”
registry analysis (superiority test); Placebo vs Casirivimab+Imdevimab Initial + Q4W; Hazard Ratio (HR) 0.563 (95% CI 0.093 to 3.393) NCT05074433 ↗
registry analysis (superiority test); Placebo vs Casirivimab+Imdevimab Q4W; Hazard Ratio (HR) 0.460 (95% CI 0.072 to 2.929) NCT05074433 ↗
registry analysis (superiority test); Placebo vs Casirivimab+Imdevimab Q12W; Cox Proportional Hazard 0.609 (95% CI 0.101 to 3.668) NCT05074433 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | casirivimab | Monoclonal antibody | — | Subcutaneous |
| Subject | imdevimab | Monoclonal antibody | — | Subcutaneous |