Efficacy of Early Administration of Tocilizumab in COVID-19 Patients

Summary

The clinical study aims at assessing whether early administration of Tocilizumab compared to late administration of Tocilizumab can reduce the number of patients with COVID-19 pneumonia who require mechanical ventilation. The clinical study includes patients with recent-onset COVID-19 pneumonia who require hospital care, but not invasive or semi-invasive mechanical ventilation procedures.

Timeline

Start

2020-03-31

Primary completion

2020-06-06

Completion

2020-06-06

Outcome

Missed primary endpoint

Stopped: “Based on interim analysis for futility and given an enrolment rate almost nil”

paper no benefit on disease progression was observed compared with standard care. PMID 33080005 ↗

paper clinical worsening within 14 days since randomization (rate ratio, 1.05; 95% CI, 0.59-1.86). PMID 33080005 ↗

Publications

• Salvarani C, Dolci G, Massari M, Merlo DF, Cavuto S, Savoldi L, Bruzzi P, Boni F, Braglia L, Turra C, Ballerini PF, Sciascia R, Zammarchi L, Para O, Scotton PG, Inojosa WO, Ravagnani V, Salerno ND, Sainaghi PP, Brignone A, Codeluppi M, Teopompi E, Milesi M, Bertomoro P, Claudio N, Salio M, Falcone M, Cenderello G, Donghi L, Del Bono V, Colombelli PL, Angheben A, Passaro A, Secondo G, Pascale R, Piazza I, Facciolongo N, Costantini M; RCT-TCZ-COVID-19 Study Group. Effect of Tocilizumab vs Standard Care on Clinical Worsening in Patients Hospitalized With COVID-19 Pneumonia: A Randomized Clinical Trial. JAMA Intern Med. 2021 Jan 1;181(1):24-31. doi: 10.1001/jamainternmed.2020.6615.

Drugs

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

Indications