NCT04425629

Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult and Pediatric Patients With COVID-19

A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Patients With COVID-19

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10,078 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Phase 1 * To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo * To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2 Phase 2 • To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2 Phase 3 * Cohort 1 (≥18 Years Old, Not Pregnant at Randomization) • To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo as measured by COVID-19-related hospitalizations or all-cause death * Cohort 2 (\<18 Years Old, Not Pregnant at Randomization) * To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo * To further characterize the concentrations of REGN10933 and REGN10987 in serum over time * Cohort 3 (Pregnant at Randomization) • To evaluate the safety and tolerability of REGN10933+REGN10987

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	casirivimab+imdevimab combination therapy	Administered intravenously (IV) single dose

Timeline

• Start date: 2020-06-16
• Primary completion: 2022-01-21
• Completion: 2022-06-09
• First posted: 2020-06-11
• Last updated: 2023-12-21
• Results posted: 2023-12-21

Locations

114 sites across 3 countries: United States, Mexico, Romania

Regulatory

• FDA-regulated drug study