Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT04452318
Brief 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
Study:
NCT04452318
Study Brief:
Protocol Section:
NCT04452318