NCT04403685

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

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)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Beneficência Portuguesa de São Paulo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• COVID
• SARS Pneumonia
• Cytokine Release Syndrome

Interventions

Type	Name	Description
DRUG	Tocilizumab	Single-dose infusion of 8 mg/kg. Maximum dose of 800 mg.

Timeline

• Start date: 2020-05-08
• Primary completion: 2020-07-08
• Completion: 2020-07-21
• First posted: 2020-05-27
• Last updated: 2020-08-26

Locations

7 sites across 1 country: Brazil