Tocilizumab in COVID-19 Pneumonia (TOCIVID-19)

Summary

Participation Requirements

Description

Phase 2 study: this is a multicenter, single-arm, open-label, phase 2 study. All the patients enrolled are treated with tocilizumab. Two-week (14 days) and one-month (30 days) lethality rates are the co-primary endpoints. The parallel cohort includes patients who are treated with tocilizumab and can...

Phase 2 study: this is a multicenter, single-arm, open-label, phase 2 study. All the patients enrolled are treated with tocilizumab. Two-week (14 days) and one-month (30 days) lethality rates are the co-primary endpoints. The parallel cohort includes patients who are treated with tocilizumab and cannot enter the phase 2 study because: emergency conditions or infrastructural or operational limits prevented registration before the administration of the experimental drug or they had been intubated more than 24 hours before registration or the phase 2 study has been closed due to reached sample size. This means that, after closure of the phase 2 enrolment, patients who might be eligible for the phase 2 study will be included in the observational cohort study. The same information planned for the phase 2 cohort is required also for the parallel cohort study whose sample size is not defined a priori, and that will close at the end of the overall project. All the patients enrolled are treated with tocilizumab. In both study groups (phase 2 and parallel cohort), participants receive one dose of Tocilizumab 8 mg/kg (up to a maximum of 800mg per dose). A second administration (same dose) can be given after 12 hours if respiratory function has not recovered, at discretion of the Investigator.

Tracking Information