Use este identificador para citar ou linkar para este item: http://repositorio.ufla.br/jspui/handle/1/45548
Título : TOCIVID-19 - A multicenter study on the efficacy and tolerability of tocilizumab in the treatment of patients with COVID-19 pneumonia. Study protocol
Autor: Piccirillo, Maria Carmela
Ascierto, Paolo
Atripaldi, Luigi
Cascella, Marco
Costantini, Massimo
Dolci, Giovanni
Facciolongo, Nicola
Fraganza, Fiorentino
Marata, AnnaMaria
Massari, Marco
Montesarchio, Vincenzo
Mussini, Cristina
Negri, Emanuele Alberto
Parrella, Roberto
Popoli, Patrizia
Botti, Gerardo
Arenare, Laura
Chiodini, Paolo
Gallo, Ciro
Salvarani, Carlo
Perrone, Francesco
Palavras-chave: COVID-19
Tocilizumab
Phase 2 study
Publicador: Elsevier
Data da publicação: Nov-2020
Referência: PICCIRILLO, M. C. et al. TOCIVID-19 - A multicenter study on the efficacy and tolerability of tocilizumab in the treatment of patients with COVID-19 pneumonia. Study protocol. Contemporary Clinical Trials, [S.l.], v. 98, Nov. 2020.
Abstract: Background Pneumonia is the most frequent complication of COVID-19, due to an aberrant host immune response that is associated with an acute respiratory distress syndrome, and, in most critical patients, with a “cytokine storm”. IL-6 might play a key role in the cytokine storm and might be a potential target to treat severe and critical COVID-19. Tocilizumab is a recombinant humanized monoclonal antibody, directed against IL-6 receptor. Methods This multicentre study project includes a single-arm phase 2 study and a further parallel cohort, enrolling hospitalized patients with COVID-19 pneumonia and oxygen saturation at rest in ambient air ≤93% or requiring respiratory support. Patients receive tocilizumab 8 mg/kg (up to 800 mg) as one intravenous administration. A second administration (same dose) after 12 h is optional. Two-week and one-month lethality rates are the co-primary endpoints. Sample size planned for the phase 2 study is 330 patients. The parallel cohort will include patients who cannot enter the phase 2 study because being intubated from more than 24 h, or having already received tocilizumab, or the phase 2 study has reached sample size. Primary analysis will include patients enrolled in the phase 2 study. Results of the primary analysis will be validated in the prospective cohort of patients consecutively registered after phase 2 closure from March 20 to March 24, who were potentially eligible for the phase 2 study. Conclusion This trial aims to verify the safety and efficacy of tocilizumab in the Italian population with COVID-19 pneumonia and respiratory impairment. EudraCT Number: 2020–001110-38; Clinicaltrials.gov ID NCT04317092
URI: https://www.sciencedirect.com/science/article/pii/S1551714420302433
http://repositorio.ufla.br/jspui/handle/1/45548
Idioma: en_US
Aparece nas coleções:FCS - Artigos sobre Coronavirus Disease 2019 (COVID-19)

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