NCT04452318

COVID-19 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-CoV-2 Infection in Household Contacts of Individuals Infected With SARS-CoV-2

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,303 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 1 Day
• Healthy volunteers: Accepted

Summary

Primary Objectives: Cohort A: • To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing symptomatic SARS-CoV-2 infection (broad-term) confirmed by RT-qPCR Cohort A and Cohort A1: • To evaluate the safety and tolerability of REGN10933+REGN10987 following subcutaneous (SC) administration compared to placebo Cohort B • To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing COVID-19 symptoms (broad-term) Cohort B and Cohort B1 • To evaluate the safety and tolerability of REGN10933+REGN10987 following SC administration compared to placebo

Detailed description

Cohort A: adult and adolescent subjects (≥12 years) who are SARS -CoV-2 RT-qPCR negative at baseline Cohort A1: pediatric subjects (\<12 years) who are SARS-CoV-2 RT--qPCR negative at baseline Cohort B: adult and adolescent subjects (≥12 years) who are SARS -CoV-2 RT-qPCR positive at baseline Cohort B1: pediatric subjects (\<12 years) who are SARS-CoV-2 RT--qPCR positive at baseline

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	REGN10933 + REGN10987	Subcutaneous (SC) or Intramuscular (IM) injections
DRUG	Placebo	SC or IM injections

Timeline

• Start date: 2020-07-13
• Primary completion: 2021-10-04
• Completion: 2021-10-04
• First posted: 2020-06-30
• Last updated: 2023-05-15
• Results posted: 2023-05-15

Locations

134 sites across 3 countries: United States, Moldova, Romania

Regulatory

• FDA-regulated drug study