Overview

COVID-19 Administration of Single-Dose Subcutaneous or Intramuscular Anti- Spike(s) SARS-CoV-2 Monoclonal Antibodies Casirivimab and Imdevimab in High-Risk Pediatric Participants Under 12 Years of Age

Status:
Recruiting
Trial end date:
2022-11-03
Target enrollment:
Participant gender:
Summary
The primary objective of the study is to characterize the concentrations of casirivimab and imdevimab in serum over time after a single subcutaneous (SC) or intramuscular (IM) administration The secondary objectives of the study are: - To assess the safety and tolerability of SC or IM single administration of casirivimab and imdevimab - To assess the occurrence of adverse events of special interest (AESIs), defined as grade ≥3 injection site reactions and grade ≥3 hypersensitivity reactions, in participants treated with SC or IM doses of casirivimab and imdevimab - To assess the immunogenicity of casirivimab and imdevimab
Phase:
Phase 2
Details
Lead Sponsor:
Regeneron Pharmaceuticals