Rationale and design of the "Tocilizumab in patients with moderate to severe COVID-19: an open-label multicentre randomized controlled" trial (TOCIBRAS).

Autor: Farias DLC; BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil., Prats J; BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil., Cavalcanti AB; Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brasil.; Instituto de Pesquisa, HCor-Hospital do Coração - São Paulo (SP), Brasil., Rosa RG; Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brasil.; Hospital Moinhos de Vento - Porto Alegre (RS), Brasil., Machado FR; Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brasil., Berwanger O; Organização de Pesquisa Acadêmica, Hospital Israelita Albert Einstein - São Paulo (SP), Brasil., Azevedo LCP; Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brasil.; Hospital Sírio-Libanês - São Paulo (SP), Brasil., Lopes RD; Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, Estados Unidos.; Brazilian Clinical Research Institute - São Paulo (SP), Brasil., Avezum Á; Centro Internacional de Pesquisa, Hospital Alemão Oswaldo Cruz - São Paulo (SP), Brasil., Kawano-Dourado L; Instituto de Pesquisa, HCor-Hospital do Coração - São Paulo (SP), Brasil., Damiani LP; Instituto de Pesquisa, HCor-Hospital do Coração - São Paulo (SP), Brasil., Rojas SSO; BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil., Oliveira CZ; BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil., Andrade LEC; Fleury Medicina e Laboratórios - São Paulo (SP), Brasil., Sandes AF; Fleury Medicina e Laboratórios - São Paulo (SP), Brasil., Pintão MC; Fleury Medicina e Laboratórios - São Paulo (SP), Brasil., Castro Júnior CG; Organização de Pesquisa Acadêmica, Hospital Israelita Albert Einstein - São Paulo (SP), Brasil.; Santa Casa de Porto Alegre - Porto Alegre (RS), Brasil., Scheinberg P; BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil., Veiga VC; BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil.; Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brasil.
Jazyk: Portuguese; English
Zdroj: Revista Brasileira de terapia intensiva [Rev Bras Ter Intensiva] 2020 Jul-Sep; Vol. 32 (3), pp. 337-347.
DOI: 10.5935/0103-507X.20200060
Abstrakt: Introduction: Pro-inflammatory markers play a significant role in the disease severity of patients with COVID-19. Thus, anti-inflammatory therapies are attractive agents for potentially combating the uncontrolled inflammatory cascade in these patients. We designed a trial testing tocilizumab versus standard of care intending to improve the outcomes by inhibiting interleukin-6, an important inflammatory mediator in COVID-19.
Methods and Analysis: This open-label multicentre randomized controlled trial will compare clinical outcomes of tocilizumab plus standard of care versus standard of care alone in patients with moderate to severe COVID-19. Two of the following four criteria are required for protocol enrolment: D-dimer > 1,000ng/mL; C reactive protein > 5mg/dL, ferritin > 300mg/dL, and lactate dehydrogenase > upper limit of normal. The primary objective will be to compare the clinical status on day 15, as measured by a 7-point ordinal scale applied in COVID-19 trials worldwide. The primary endpoint will be assessed by an ordinal logistic regression assuming proportional odds ratios adjusted for stratification variables (age and sex).
Ethics and Dissemination: The TOCIBRAS protocol was approved by local and central (national) ethical committees in Brazil following current national and international guidelines/directives. Each participating center had the study protocol approved by their institutional review boards before initiating protocol enrolment. The data derived from this trial will be published regardless of the results. If proven active, this strategy could alleviate the consequences of the inflammatory response in COVID-19 patients and improve their clinical outcomes.
Databáze: MEDLINE
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