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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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