Tag: studio di fase due

Publication date: 12/05/2020 – E&P Code: repo.epiprev.it/1610
Authors: Paolo Chiodini¹, Laura Arenare², Maria Carmela Piccirillo², Francesco Perrone², Ciro Gallo¹

Abstract: Background. Tocilizumab, an IL-6 receptor antagonist, was suggested as a possible treatment of severe or critical COVID-19 pneumonia in a small Chinese study. The TOCIVID-19 trial evaluates efficacy and tolerability of tocilizumab in the treatment of patients with severe or critical COVID-19 pneumonia.
Methods/design. TOCIVID-19is an academic multicenter, single-arm, open-label, phase 2 study. All the patients are being offered a single shot of 8 mg/kg of Tocilizumab (up to a maximum of 800 mg), with an eventual second administration at the discretion of the Investigator. A companion prospective cohort includes either patients not eligible for phase 2 or subjects eligible for phase 2 but exceeding the planned sample size. 14- and 30-days lethality rates are the two co-primary endpoints in the intention-to-treat (ITT) population. Secondary objectives are to evaluate mortality and clinical improvement in the modified-ITT population of subjects who received the drug. Details of the methodological and statistical approaches are reported here reflecting the amendments impelled by the continuously increasing knowledge on COVID-19 progression and troubles in data collection.
Discussion. This paper provides details of planned statistical analyses for TOCIVID19 trial to reduce the risk of reporting bias and increase credibility of the study findings.
TOCIVID-19 trials registered in the EudraCT database with number 2020-001110-38 and in clinicaltrials.gov with ID NCT04317092.

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Publication date: 12/05/2020 – E&P Code: repo.epiprev.it/1604
Authors: Maria Carmela Piccirillo¹, Paolo Ascierto¹, Luigi Atripaldi², Marco Cascella¹, Massimo Costantini³, Giovanni Dolci^3-4, Nicola Facciolongo³, Fiorentino Fragranza², AnnaMaria Marata⁵, Marco Massari³, Vincenzo Montesarchio², Cristina Mussini⁴, Emanuele Alberto Negri³, Roberto Parrella², Patrizia Popoli⁶, Gerardo Botti¹, Laura Arenare¹, Paolo Chiodini⁷, Ciro Gallo⁷, Carlo Salvarani^3-4, Francesco Perrone¹

Abstract: Background: Pneumonia is the most frequent and serious complication of COVID-19, due to an excessive and aberrant host immune response that is associated with an acute respiratory distress syndrome, with typical radiological findings and, in most critical patients, with a “cytokine storm”. IL-6 might play a key role in the cytokine storm induced bySARS-CoV-2 and interfering of IL-6 might be a potentially therapeutic strategy for severe and critical COVID-19. Tocilizumab is a recombinant humanized monoclonal antibody, directed against IL-6 receptor.

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