Tocilizumab in Hospitalized Patients with Severe Covid-19 Pneumonia

Abstract (PubMed)

Background: Tocilizumab, an interleukin-6 receptor antagonist, has been proposed as a treatment for the cytokine storm associated with severe Covid-19 pneumonia. Methods: We conducted a phase 3, randomized, double-blind, placebo-controlled trial in 62 hospitals across 9 countries. Patients (n=452) with severe Covid-19 pneumonia received tocilizumab (8 mg/kg IV, maximum 800 mg) or placebo in a 2:1 ratio. The primary outcome was clinical status at day 28 on a 7-category ordinal scale. Results: The primary outcome showed no significant difference between tocilizumab and placebo (P=0.31). Mortality at day 28 was 19.7% with tocilizumab and 19.6% with placebo (weighted difference 0.3 pp; 95% CI, -7.6 to 8.2; P=0.94). Time to hospital discharge was shorter with tocilizumab (median 20 vs. 28 days, HR 1.35; 95% CI, 1.02-1.79). The incidence of serious adverse events was 34.9% with tocilizumab vs. 38.5% with placebo. Conclusions: Tocilizumab did not improve clinical status at day 28 in patients with severe Covid-19 pneumonia.