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

Summary

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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 wi...

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.

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