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A Study to Evaluate the Efficacy and Safety of Itolizumab in Subjects Hospitalized With COVID-19 — EQUINOX  

Coronavirus Clinical Trial

Official title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Itolizumab in Subjects Hospitalized With COVID-19

Clinical Trial Summary

This is a randomized controlled trial to evaluate the efficacy and safety of itolizumab in subjects hospitalized with COVID-19.

Clinical Trial Description

This study will randomize up to 800 subjects in a 1:1 ratio; itolizumab vs. placebo. Subjects will receive either itolizumab or placebo administered intravenously on Day 1 and Day 8 with follow-up to Day 90. Two interim analyses of futility are planned. The first will take place when approximately 20% of the subjects have been evaluated for the primary endpoint, and the second will take place when approximately 50% of the subjects have been evaluated for the primary endpoint. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04605926
Study type Interventional
Source Equillium
Contact
Status Withdrawn
Phase Phase 3
Start date November 2020
Completion date June 2021
View Details
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