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
Stopped early · Phase 2
Conditions studied: COVID-19
In brief
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
Key facts
- Study ID
- NCT04992273
- Run by
- Regeneron Pharmaceuticals
- People needed
- 7
- Starts
- 2021-09-13
- Expected to finish
- 2022-06-01
- Last updated by the study team
- 2025-10-20
Who can join
Age: any, up to 12. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Advanced Research Center, Inc — Anaheim, California, United States
- Batchelor's Children's Research Institute — Miami, Florida, United States
- Stony Brook University Hospital — Stony Brook, New York, United States
- SUNY Upstate Medical University — Syracuse, New York, United States
- Jacobi Medical Center — The Bronx, New York, United States
- Coastal Pediatric Research — Charleston, South Carolina, United States
- Regeneron Research Site — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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