NCT05074433

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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies as Pre-Exposure Prophylaxis to Prevent COVID-19 in Immunocompromised Participants

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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

Conditions

• Immunocompromised

Interventions

Type	Name	Description
DRUG	casirivimab+imdevimab	Co-administered sequentially subcutaneous (SC)
DRUG	Placebo	Administered SC

Timeline

• Start date: 2021-10-25
• Primary completion: 2022-05-18
• Completion: 2022-05-18
• First posted: 2021-10-12
• Last updated: 2025-10-20
• Results posted: 2023-07-24

Locations

67 sites across 2 countries: United States, Mexico

Regulatory

• FDA-regulated drug study