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.