A Phase 3 interventional study of Tocilizumab in COVID, SARS Pneumonia and Cytokine Release Syndrome, sponsored by Beneficência Portuguesa de São Paulo. Terminated at 7 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-26.
Sponsored by Beneficência Portuguesa de São Paulo · Phase 3, Interventional, and Treatment
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.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's enrollment of 129 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Beneficência Portuguesa de São Paulo is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Both of the criteria
At least two of the following inflammatory tests above the cutoff :
Exclusion Criteria:
Single-dose tocilizumab of 8 mg/kg (maximum dose of 800mg). Best supportive care.
Drug: Tocilizumab
Best supportive care.
Single-dose infusion of 8 mg/kg. Maximum dose of 800 mg.
Also known as: Actemra
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
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)
Correlation of inflammatory tests and cytokines with clinical outcomes
Correlation of inflammatory tests and cytokines with clinical outcomes: clinical status (ordinal scale), time to oxygen support independence, ventilator free days, need of mechanical ventilation and mortality
Time frame: 29 days after the randomization
Exploratory evaluation of laboratory exams during hospitalization
Evaluation the kinetics of hemostasia exams, inflammatory tests, cytokines, flow cytometry of blood cells, CBC, renal and liver exams
Time frame: 29 days after the randomization
Evaluation of viral clearance of SARS-CoV2
Evaluation of viral clearance of SARS-CoV2 using RT-PCR analysis of nasopharyngeal swab
Time frame: Day 8 and 15 after randomization
Plan to share: No
This study is terminated, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Beneficência Portuguesa de São Paulo