NCT05092581

COVID-19 Study of Pharmacokinetics, Safety, Tolerability, and Efficacy of Intravenous Anti-Spike(s) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) for the Treatment of Pediatric Patients Hospitalized Due to COVID-19

A Phase 1b, Open-Label, Single Dose Study Assessing the Pharmacokinetics, Safety, Tolerability, and Efficacy of Intravenous Anti-Spike(s) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) for the Treatment of Pediatric Patients Hospitalized Due to COVID-19

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 1 Minute – 17 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of the study are: * To characterize the concentrations of casirivimab+imdevimab in serum over time * To evaluate the safety and tolerability of casirivimab+imdevimab The secondary objective of the study is: • To assess the immunogenicity of casirivimab+imdevimab

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	casirivimab+imdevimab	Single dose weight-based equivalent administered intravenously (IV)

Timeline

• Start date: 2021-12-16
• Primary completion: 2022-06-09
• Completion: 2022-06-09
• First posted: 2021-10-25
• Last updated: 2025-10-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study