drugset / Trial / 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
Non-randomizedSingle-groupOpen-labelTreatment
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
Timeline
- Start
- 2021-09-13
- Primary completion
- 2022-06-01
- Completion
- 2022-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | casirivimab | Monoclonal antibody | — | Subcutaneous |
| Subject | imdevimab | Monoclonal antibody | — | Subcutaneous |