NCT04426695

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 2,252 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives are: Pooled Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) * To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2 * To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation Phase 1/2 (Cohort 1) * To exclude futility of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation * To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	REGN10933+REGN10987 combination therapy	Administered intravenously (IV) single dose
DRUG	Placebo	Placebo IV Single Dose

Timeline

• Start date: 2020-06-10
• Primary completion: 2021-05-07
• Completion: 2021-10-22
• First posted: 2020-06-11
• Last updated: 2023-01-27
• Results posted: 2022-07-25

Locations

123 sites across 6 countries: United States, Brazil, Chile, Mexico, Moldova, Romania

Regulatory

• FDA-regulated drug study