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Campo DC | Valor | Idioma |
---|---|---|
dc.creator | Piccirillo, Maria Carmela | - |
dc.creator | Ascierto, Paolo | - |
dc.creator | Atripaldi, Luigi | - |
dc.creator | Cascella, Marco | - |
dc.creator | Costantini, Massimo | - |
dc.creator | Dolci, Giovanni | - |
dc.creator | Facciolongo, Nicola | - |
dc.creator | Fraganza, Fiorentino | - |
dc.creator | Marata, AnnaMaria | - |
dc.creator | Massari, Marco | - |
dc.creator | Montesarchio, Vincenzo | - |
dc.creator | Mussini, Cristina | - |
dc.creator | Negri, Emanuele Alberto | - |
dc.creator | Parrella, Roberto | - |
dc.creator | Popoli, Patrizia | - |
dc.creator | Botti, Gerardo | - |
dc.creator | Arenare, Laura | - |
dc.creator | Chiodini, Paolo | - |
dc.creator | Gallo, Ciro | - |
dc.creator | Salvarani, Carlo | - |
dc.creator | Perrone, Francesco | - |
dc.date.accessioned | 2020-11-18T16:57:59Z | - |
dc.date.available | 2020-11-18T16:57:59Z | - |
dc.date.issued | 2020-11 | - |
dc.identifier.citation | 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. | pt_BR |
dc.identifier.uri | https://www.sciencedirect.com/science/article/pii/S1551714420302433 | pt_BR |
dc.identifier.uri | http://repositorio.ufla.br/jspui/handle/1/45548 | - |
dc.description.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 | pt_BR |
dc.language | en_US | pt_BR |
dc.publisher | Elsevier | pt_BR |
dc.rights | restrictAccess | pt_BR |
dc.source | Contemporary Clinical Trials | pt_BR |
dc.subject | COVID-19 | pt_BR |
dc.subject | Tocilizumab | pt_BR |
dc.subject | Phase 2 study | pt_BR |
dc.title | TOCIVID-19 - A multicenter study on the efficacy and tolerability of tocilizumab in the treatment of patients with COVID-19 pneumonia. Study protocol | pt_BR |
dc.type | Artigo | pt_BR |
Aparece nas coleções: | FCS - Artigos sobre Coronavirus Disease 2019 (COVID-19) |
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