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

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About: Tocilizumab for patients with COVID-19 pneumonia. The TOCIVID-19 phase 2 trial Goto Sponge NotDistinct Permalink

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Tocilizumab for patients with COVID-19 pneumonia. The TOCIVID-19 phase 2 trial
Creator	Botti, Gerardo Castelli, Francesco Massari, Marco Lichtner, Miriam Cascella, Marco Salvarani, Carlo Montesarchio, Vincenzo Ripamonti, Diego Arenare, Laura Ascierto, Paolo Atripaldi, Luigi Binda, Francesca Bonfanti, Paolo Calzetti, Carlo Cardone, Claudia Chiodini, Paolo Costantini, Massimo Dolci, Giovanni Facciolongo, Nicola Ferraris, Laurenzia Fraganza, Fiorentino Gallo, Ciro Gargiulo, Piera Gravina, Adriano Marata, Anna Marrocco-Trischitta, Massimiliano Muiesan, Maria Mussini, Cristina Negri, Emanuele Parrella, Roberto Perrone, Francesco Piccirillo, Maria Popoli, Patrizia Salerno, Nicola Schettino, Clorinda Squillace, Nicola
Source	MedRxiv
abstract	Background: Tocilizumab blocks pro-inflammatory activity of interleukin-6 (IL-6) which might be important in the pathogenesis of interstitial pneumonia. Objective: to evaluate efficacy of tocilizumab in COVID-19 pneumonia patients. Design: multicenter single-arm phase 2 trial, powered to detect 10% absolute lethality rate reduction at 14 and 30-days, with 20% and 35% expected rates. A consecutive prospective validation cohort was also evaluated. Setting: 185 Italian public hospitals, during coronavirus breakout. Patients: 1221 patients hospitalized with pneumonia, from March 19th to 24th, 2020. Intervention: tocilizumab 8 mg/kg, intravenously, one or two administrations with 12 hours interval. Measurements: lethality rates at 14 and 30-days; safety according to CTCAE. Results: 301 and 920 cases were available for intention-to-treat (ITT) analysis in phase 2 and validation cohorts. 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. Limitations: single-arm design. In addition, delayed availability of the drug induced indication bias and immortal time bias. Conclusion: 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.
has issue date	2020-06-05(xsd:dateTime)
bibo:doi	10.1101/2020.06.01.20119149
has license	medrxiv
sha1sum (hex)	bdede964acaceb3ed6f7bc37e97f9a64d3b3b3d5
schema:url	https://doi.org/10.1101/2020.06.01.20119149
resource representing a document's title	Tocilizumab for patients with COVID-19 pneumonia. The TOCIVID-19 phase 2 trial
resource representing a document's body	covid:bdede964acaceb3ed6f7bc37e97f9a64d3b3b3d5#body_text
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