NCT04992273

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

A Phase 2A, Open-Label Study Assessing Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Single-Dose Subcutaneous Anti- Spike(s) SARS-COV-2 Monoclonal Antibodies (Casirivimab and Imdevimab) in High-Risk Pediatric Subjects Under 12 Years of Age

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 1 Minute – 12 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to characterize the concentrations of casirivimab+imdevimab in serum over time after a single subcutaneous (SC) administration The secondary objectives of the study are: * To assess the safety and tolerability of SC or single administration of casirivimab+imdevimab * To assess the occurrence of grade ≥3 injection site reactions and grade ≥3 hypersensitivity reactions, in participants treated with SC doses of casirivimab+imdevimab * To assess the immunogenicity of casirivimab+imdevimab

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	casirivimab+imdevimab	Single dose administered based on weight

Timeline

• Start date: 2021-09-13
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2021-08-05
• Last updated: 2025-10-20
• Results posted: 2023-03-06

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study