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Tocilizumab for patients with COVID-19 pneumonia. The single-arm TOCIVID-19 prospective trial
- Source :
- Journal of Translational Medicine, Vol 18, Iss 1, Pp 1-11 (2020)
- Publication Year :
- 2020
- Publisher :
- BMC, 2020.
-
Abstract
- 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 population, 180/301 (59.8%) subjects received tocilizumab, and 67 deaths were observed overall. Lethality rates were equal to 18.4% (97.5% CI: 13.6–24.0, P = 0.52) and 22.4% (97.5% CI: 17.2–28.3, P
- Subjects :
- COVID-19
Pneumonia
Coronavirus
Tocilizumab
IL-6
Phase 2
Medicine
Subjects
Details
- Language :
- English
- ISSN :
- 14795876
- Volume :
- 18
- Issue :
- 1
- Database :
- Directory of Open Access Journals
- Journal :
- Journal of Translational Medicine
- Publication Type :
- Academic Journal
- Accession number :
- edsdoj.4637cd417044b5db858ae56b89d1e81
- Document Type :
- article
- Full Text :
- https://doi.org/10.1186/s12967-020-02573-9