Status and phase
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Treatments
About
The trial evaluates the efficacy and safety of Tocilizumab, which rapidly reduces the inflammation process through inhibition of IL-6 in patients with moderate to severe COVID-19 with increased inflammatory markers. There will be two arms in the trial, one receiving the best supportive care, and the other receiving it plus tocilizumab. Patients will be followed until Day 29 after randomization.
Full description
Coalition VI (TOCIBRÁS) is a prospective phase III randomized controlled trial that evaluates the efficacy and safety of Tocilizumab, an antibody anti-IL-6 receptor in patients with moderate to severe COVID-19 with increased inflammatory markers. This is a superiority open-label study with two arms. The control arm receives the best supportive care, and the experimental receives it plus tocilizumab. Randomization is done centrally by REDCap 1:1. Patients will be followed until Day 29 after randomization.
Enrollment
Sex
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Volunteers
Inclusion criteria
Male and females with 18 years and older
Confirmed diagnosis of SARS-CoV 2 infection
More than 3 days of symptoms related to COVID-19
Computed tomography (or Chest X-Ray) with COVID-19 alterations
Both of the criteria
Need for oxygen supplementation to keep SPO2 > 93% OR need for mechanical ventilation for less than 24 hours before the randomization
At least two of the following inflammatory tests above the cutoff :
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
129 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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