Use of the Interleukin-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection

Covid19 Clinical Trial

Official title: A Randomized Placebo-controlled Safety and Dose-finding Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection

Status Recruiting

Clinical Trial Summary

In this study Investigators propose to administer clazakizumab to patients with life-threatening COVID-19 infection manifest by pulmonary failure and a clinical picture consistent with a cytokine storm syndrome. This is a single-center randomized, double-blind, placebo-controlled trial in which 30 patients will be enrolled and randomly assigned in a 1:1 ratio to two study arms that will receive clazakizumab at a dose of 25 mg or placebo.

Clinical Trial Description

In this study Investigators propose to administer clazakizumab to patients with severe COVID-19 infection manifest by pulmonary failure and a clinical picture consistent with a cytokine storm syndrome. This is a single-center randomized, double-blind, placebo-controlled trial in which 30 patients will be enrolled and randomly assigned in a 1:1 ratio to three study arms that will receive clazakizumab at a dose of 25 mg or placebo.

The primary endpoint is patient safety assessed by serious adverse events associated with clazakizumab or placebo.

The secondary endpoints are: incidence of intubation, time to extubation, length of ICU stay, severity of AKI, need for RRT, duration of RRT, trend in C-reactive protein, and patient survival at 28 and 60 days. ;

Related Conditions & MeSH terms

• Covid19
• Infection

• NCT number: NCT04363502
• Study type: Interventional
• Source: Johns Hopkins University
• Contact: Nada Alachkar, MD
• Phone: 4106149225
• Email: nalachk1@jhmi.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: May 7, 2020
• Completion date: May 2022