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

Phase 3 Terminated 129 enrolled Beneficência Portuguesa de São Paulo Brazilian Clinical Research Institute · collab Brazilian Research In Intensive Care Network · collab Federal University of São Paulo · collab Hospital Alemão Oswaldo Cruz · collab Hospital Israelita Albert Einstein · collab Hospital Moinhos de Vento · collab Hospital Sirio-Libanes · collab Hospital do Coracao · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2020-05-08
Primary completion: 2020-07-08
Completion: 2020-07-21

Outcome

Missed primary endpoint

Stopped: “Safety”

paper tocilizumab plus standard care was not superior to standard care alone PMID 33472855 ↗

Publications

Veiga VC, Prats JAGG, Farias DLC, Rosa RG, Dourado LK, Zampieri FG, Machado FR, Lopes RD, Berwanger O, Azevedo LCP, Avezum A, Lisboa TC, Rojas SSO, Coelho JC, Leite RT, Carvalho JC, Andrade LEC, Sandes AF, Pintao MCT, Castro CG Jr, Santos SV, de Almeida TML, Costa AN, Gebara OCE, de Freitas FGR, Pacheco ES, Machado DJB, Martin J, Conceicao FG, Siqueira SRR, Damiani LP, Ishihara LM, Schneider D, de Souza D, Cavalcanti AB, Scheinberg P; Coalition covid-19 Brazil VI Investigators. Effect of tocilizumab on clinical outcomes at 15 days in patients with severe or critical coronavirus disease 2019: randomised controlled trial. BMJ. 2021 Jan 20;372:n84. doi: 10.1136/bmj.n84.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tocilizumab	Monoclonal antibody	8 mg/kg	Intravenous