NCT04605926

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

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Equillium · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Coronavirus

Interventions

Type	Name	Description
BIOLOGICAL	EQ001	itolizumab \[Bmab600\]
BIOLOGICAL	EQ001 Placebo	EQ001 Placebo

Timeline

• Start date: 2020-11-01
• Primary completion: 2021-04-01
• Completion: 2021-06-01
• First posted: 2020-10-28
• Last updated: 2021-01-27

Locations

1 site across 1 country: Colombia

Regulatory

• FDA-regulated drug study