Tocilizumab for patients with COVID-19 pneumonia. The single-arm TOCIVID-19 prospective trial.

ABSTRACT:

Background

Tocilizumab blocks pro-inflammatory activity of interleukin-6 (IL-6), involved in pathogenesis of pneumonia the most frequent cause of death in COVID-19 patients.

Methods

A multicenter, single-arm, hypothesis-driven trial was planned, according to a phase 2 design, to study the effect of tocilizumab on lethality rates at 14 and 30 days (co-primary endpoints, a priori expected rates being 20 and 35%, respectively). A further prospective cohort of patients, consecutively enrolled after the first cohort was accomplished, was used as a secondary validation dataset. The two cohorts were evaluated jointly in an exploratory multivariable logistic regression model to assess prognostic variables on survival.

Results

In the primary intention-to-treat (ITT) phase 2 po

SUBMITTER: Perrone F 

PROVIDER: S-EPMC7576974 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature