Use este identificador para citar ou linkar para este item: http://repositorio.ufla.br/jspui/handle/1/45548
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dc.creatorPiccirillo, Maria Carmela-
dc.creatorAscierto, Paolo-
dc.creatorAtripaldi, Luigi-
dc.creatorCascella, Marco-
dc.creatorCostantini, Massimo-
dc.creatorDolci, Giovanni-
dc.creatorFacciolongo, Nicola-
dc.creatorFraganza, Fiorentino-
dc.creatorMarata, AnnaMaria-
dc.creatorMassari, Marco-
dc.creatorMontesarchio, Vincenzo-
dc.creatorMussini, Cristina-
dc.creatorNegri, Emanuele Alberto-
dc.creatorParrella, Roberto-
dc.creatorPopoli, Patrizia-
dc.creatorBotti, Gerardo-
dc.creatorArenare, Laura-
dc.creatorChiodini, Paolo-
dc.creatorGallo, Ciro-
dc.creatorSalvarani, Carlo-
dc.creatorPerrone, Francesco-
dc.date.accessioned2020-11-18T16:57:59Z-
dc.date.available2020-11-18T16:57:59Z-
dc.date.issued2020-11-
dc.identifier.citationPICCIRILLO, 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.urihttps://www.sciencedirect.com/science/article/pii/S1551714420302433pt_BR
dc.identifier.urihttp://repositorio.ufla.br/jspui/handle/1/45548-
dc.description.abstractBackground 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 NCT04317092pt_BR
dc.languageen_USpt_BR
dc.publisherElsevierpt_BR
dc.rightsrestrictAccesspt_BR
dc.sourceContemporary Clinical Trialspt_BR
dc.subjectCOVID-19pt_BR
dc.subjectTocilizumabpt_BR
dc.subjectPhase 2 studypt_BR
dc.titleTOCIVID-19 - A multicenter study on the efficacy and tolerability of tocilizumab in the treatment of patients with COVID-19 pneumonia. Study protocolpt_BR
dc.typeArtigopt_BR
Aparece nas coleções:FCS - Artigos sobre Coronavirus Disease 2019 (COVID-19)

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