NCT04666441

COVID-19 Study Assessing the Virologic Efficacy of REGN10933+REGN10987 Across Different Dose Regimens in Adult Outpatients With SARS-CoV-2 Infection

A Phase 2 Study to Assess the Virologic Efficacy of REGN10933+REGN10987 Across Different Dose Regimens in Outpatients With SARS-CoV-2 Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,149 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to assess the virologic efficacy of REGN10933+REGN10987 across different intravenous and subcutaneous doses compared to placebo. The secondary objectives of the study are: * To evaluate additional indicators of virologic efficacy of REGN10933+REGN10987 compared to placebo * To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo * To assess the concentrations of REGN10933 and REGN10987 in serum over time * To assess the immunogenicity of REGN10933 and REGN10987

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	REGN10933+REGN10987 combination therapy	Administered IV or SC single dose
DRUG	Placebo	Administered IV or SC single dose to match

Timeline

• Start date: 2020-12-15
• Primary completion: 2021-03-04
• Completion: 2021-09-21
• First posted: 2020-12-14
• Last updated: 2022-04-08
• Results posted: 2022-04-08

Locations

57 sites across 1 country: United States

Regulatory

• FDA-regulated drug study