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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
129
Single-dose infusion of 8 mg/kg. Maximum dose of 800 mg.
HCOR -Hospital do Coracao
São Paulo, São Paulo, Brazil
UNIFESP
São Paulo, São Paulo, Brazil
HAOC - Hospital Alemao Oswaldo Cruz
São Paulo, Brazil
Beneficência Portuguesa de Sao Paulo
São Paulo, Brazil
Evaluation of clinical status
Evaluation of clinical status of patients on day 15 after randomization, defined by the Ordinal Scale of 7 points (score ranges from 1 to 7, with 7 being the worst score)
Time frame: Day 15 of the trial
All-cause mortality
All-cause mortality from randomization to day 28
Time frame: 29 days after the randomization
Hospital Mortality
Deaths that occur during hospital admission.
Time frame: 29 days after the randomization
Improvement of Sequential Sepsis-related Organ Failure Assessment (SOFA) scale
Improvement of SOFA scale of patients at day 8, 15 and 29 after randomization
Time frame: 29 days after the randomization (evaluations at D8 and D15)
Evaluation of clinical status
Evaluation of clinical status of patients on the day 8, 22 and 29 after randomization, defined by the Ordinal Scale of 7 points (score ranges from 1 to 7, with 7 being the worst score)
Time frame: 29 days after the randomization (evaluations at D8 and D29)
Ventilator free days
Days alive and free from mechanical ventilation since randomization
Time frame: 29 days after the randomization
Time until oxygen support independence
Days from randomization to independence of oxygen support
Time frame: 29 days after the randomization
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HAOC - Hospital Alemao Oswaldo Cruz - unidade Vergueiro
São Paulo, Brazil
HIAE - Hospital Israelita Albert Einstein
São Paulo, Brazil
HSL - Hospital Sírio Libanês
São Paulo, Brazil
Need of mechanical ventilation support
Number of patients that were not at mechanical ventilation at randomization and that required that support.
Time frame: 29 days after the randomization
Days to mechanical ventilation support.
Number of days to mechanical ventilation for patients that were not receiving it at randomization. For patients that were not in mechanical ventilation at randomization: number of days until that support was required.
Time frame: 29 days after the randomization
Duration of hospitalization
Lenght of hospitalization stay in survivors (in days)
Time frame: 29 days after the randomization
Other infections
Incidence of other infections (aside from SARS-CoV 2)
Time frame: 29 days after the randomization
Incidence of thromboembolic events
Incidence of thromboembolic events in patients with COVID-19
Time frame: 29 days after the randomization
Incidence of adverse events
Evaluation of adverse events, as well as serious and unexpected adverse events
Time frame: 29 days after the randomization (specific evaluations at D8, D15 and D29)