drugset
drugset / Trial / 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

NCT05092581 ↗

Phase 1 Terminated 2 enrolled Regeneron Pharmaceuticals
NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2021-12-16
Primary completion
2022-06-09
Completion
2022-06-09

Outcome

Outcome not reported

Stopped: “Emerging SARS-CoV-2 variants impacting susceptibility to study drug”

Drugs

EvaluationDrugModalityDoseRoute
Subject casirivimab Monoclonal antibody — Intravenous
Subject imdevimab Monoclonal antibody — Intravenous

Indications

COVID-19