(06 June 2020) Tocilizumab- reduced lethality rate at 30 but not at 14-days

Tocilizumab for patients with COVID-19 pneumonia. The TOCIVID-19 phase 2 trial

https://doi.org/10.1101/2020.06.01.20119149

301 and 920 cases were available for intention-to-treat (ITT) analysis in phase 2 and validation cohorts (Registration. EudraCT (2020-001110-38); clinicaltrials.gov (NCT04317092)). Due to delayed drug availability, 60% of patients received tocilizumab, and with some delays. In phase 2, 67 patients died; lethality rates were 18.4% (97.5%CI: 13.6-24.0, P=0.52) and 22.4% (97.5%CI: 17.2-28.3, P<0.001) at 14 and 30- days. Lower rates (15.6% and 20.0%) were reported in the modified ITT including only treated patients (mITT). Lethality rates in the validation cohort were smaller than in phase
2, at 14 and 30 days and in ITT and mITT populations. Multivariable logistic regression model suggests tocilizumab be more effective in patients not requiring mechanical respiratory support at baseline. No relevant signal of specific drug toxicity was reported, many severe adverse events being disease-related. Tocilizumab reduced lethality rate at 30 but not at 14-days, compared with the expectations, without significant toxicity. Efficacy was more evident among patients not requiring mechanical respiratory support.