This will be the first global study of tocilizumab in this setting and is expected to begin enrolling in early April, with a target of approximately 330 patients globally.
As cases of the novel coronavirus (COVID-19) continue to rise in the United States, a phase 3 trial investigating the safety and efficacy of tocilizumab (Actemra, Genentech) in patients with severe COVID-19 pneumonia has been initiated.
This will be the first global study of tocilizumab in this setting and is expected to begin enrolling in early April, with a target of approximately 330 patients globally. The primary and secondary endpoints include clinical status, mortality, mechanical ventilation, and intensive care unit variables.
Tocilizumab was the first humanized interleukin-6 receptor antagonist approved for adult patients with moderately to severely active rheumatoid arthritis who have used 1 or more disease-modifying antirheumatic drugs. The drug does alter the patient’s immune system, which can make them more susceptible to infections or make a current infection worse.
Some serious adverse effects (AEs) can include stomach or intestinal tearing, hepatotoxicity, and low neutrophil and platelet counts. In earlier clinical trials, the most commonly reported AEs were upper respiratory tract infections, headache, hypertension, and injection site reactions.
The new study will be randomized, double-blind, and placebo-controlled. Patients will be followed for 60 days following randomization, and an interim analysis will be conducted to look for early evidence of efficacy.
Several other independent clinical trials are evaluating the efficacy and safety of tocilizumab for the treatment of patients with COVID-19 pneumonia. The drug was included in the seventh updated diagnosis and treatment plan for COVID-19 issued by China’s National Health Commission. The new trial is notable, however, due to the limited published evidence on the safety or efficacy in patients with COVID-19.
Tocilizumab is not currently FDA-approved for use in patients with COVID-19.
Genentech Initiates Phase III Clinical Trial of Actemra In Hospitalized Patients With Severe COVID-19 Pneumonia [news release]. Genentech; March 18, 2020. https://www.gene.com/media/press-releases/14841/2020-03-18/genentech-initiates-phase-iii-clinical-t. Accessed March 19, 2020.