CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 2,252 enrolled
Drug / intervention
REGN10933+REGN10987 combination therapy +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04426695
NCT04426695Phase 2Completed
CompareCT.gov

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

Regeneron Pharmaceuticals·interventional·Posted Jun 11, 2020·Updated Jan 27, 2023

In Brief

A Phase 2 clinical trial evaluating REGN10933+REGN10987 combination therapy and Placebo for COVID-19. Completed, enrolled 2,252 participants across 123 sites in 6 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesBrazil, Chile, Mexico, Moldova, Romania, United States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJun 11, 2020
Enrollment StartJun 10, 2020
Primary CompletionMay 7, 2021
Study CompletionOct 22, 2021
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 6.1 years ago

Interventions

REGN10933+REGN10987 combination therapydrug

Administered intravenously (IV) single dose

Placebodrug

Placebo IV Single Dose