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Safety and Efficacy of Tocilizumab in Moderate to Severe COVID-19 With Inflammatory Markers — TOCIBRAS  

COVID Clinical Trial

Official title:
Safety and Efficacy of Tocilizumab in Moderate to Severe COVID-19 and Increased Inflammatory Markers: a Phase III Randomized Clinical Trial (COVID-19 Coalition Brazil VI) (TOCIBRAS)

Clinical Trial Summary

The trial evaluates the efficacy and safety of Tocilizumab, which rapidly reduces the inflammation process through inhibition of IL-6 in patients with moderate to severe COVID-19 with increased inflammatory markers. There will be two arms in the trial, one receiving the best supportive care, and the other receiving it plus tocilizumab. Patients will be followed until Day 29 after randomization.

Clinical Trial Description

Coalition VI (TOCIBRÁS) is a prospective phase III randomized controlled trial that evaluates the efficacy and safety of Tocilizumab, an antibody anti-IL-6 receptor in patients with moderate to severe COVID-19 with increased inflammatory markers. This is a superiority open-label study with two arms. The control arm receives the best supportive care, and the experimental receives it plus tocilizumab. Randomization is done centrally by REDCap 1:1. Patients will be followed until Day 29 after randomization. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04403685
Study type Interventional
Source Beneficência Portuguesa de São Paulo
Contact
Status Terminated
Phase Phase 3
Start date May 8, 2020
Completion date July 21, 2020
View Details
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