TOCIVID-19 - A multicenter study on the efficacy and tolerability of tocilizumab in the treatment of patients with COVID-19 pneumonia. Study protocol

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Autor(es): dc.creatorPiccirillo, Maria Carmela-
Autor(es): dc.creatorAscierto, Paolo-
Autor(es): dc.creatorAtripaldi, Luigi-
Autor(es): dc.creatorCascella, Marco-
Autor(es): dc.creatorCostantini, Massimo-
Autor(es): dc.creatorDolci, Giovanni-
Autor(es): dc.creatorFacciolongo, Nicola-
Autor(es): dc.creatorFraganza, Fiorentino-
Autor(es): dc.creatorMarata, AnnaMaria-
Autor(es): dc.creatorMassari, Marco-
Autor(es): dc.creatorMontesarchio, Vincenzo-
Autor(es): dc.creatorMussini, Cristina-
Autor(es): dc.creatorNegri, Emanuele Alberto-
Autor(es): dc.creatorParrella, Roberto-
Autor(es): dc.creatorPopoli, Patrizia-
Autor(es): dc.creatorBotti, Gerardo-
Autor(es): dc.creatorArenare, Laura-
Autor(es): dc.creatorChiodini, Paolo-
Autor(es): dc.creatorGallo, Ciro-
Autor(es): dc.creatorSalvarani, Carlo-
Autor(es): dc.creatorPerrone, Francesco-
Data de aceite: dc.date.accessioned2026-02-09T11:39:21Z-
Data de disponibilização: dc.date.available2026-02-09T11:39:21Z-
Data de envio: dc.date.issued2020-11-17-
Data de envio: dc.date.issued2020-11-17-
Data de envio: dc.date.issued2020-10-
Fonte completa do material: dc.identifierhttps://repositorio.ufla.br/handle/1/45548-
Fonte completa do material: dc.identifierhttps://www.sciencedirect.com/science/article/pii/S1551714420302433-
Fonte: dc.identifier.urihttp://educapes.capes.gov.br/handle/capes/1144484-
Descrição: dc.descriptionBackground 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-
Idioma: dc.languageen-
Publicador: dc.publisherElsevier-
Direitos: dc.rightsrestrictAccess-
???dc.source???: dc.sourceContemporary Clinical Trials-
Palavras-chave: dc.subjectCOVID-19-
Palavras-chave: dc.subjectTocilizumab-
Palavras-chave: dc.subjectPhase 2 study-
Título: dc.titleTOCIVID-19 - A multicenter study on the efficacy and tolerability of tocilizumab in the treatment of patients with COVID-19 pneumonia. Study protocol-
Tipo de arquivo: dc.typeArtigo-
Aparece nas coleções:Repositório Institucional da Universidade Federal de Lavras (RIUFLA)

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