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Safety
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| Name | Class |
|---|---|
| Hospital do Coracao | OTHER |
| Hospital Israelita Albert Einstein | OTHER |
| Hospital Sirio-Libanes | OTHER |
| Hospital Alemão Oswaldo Cruz |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tocilizumab | Experimental | Single-dose tocilizumab of 8 mg/kg (maximum dose of 800mg). Best supportive care. |
|
| Control arm | No Intervention | Best supportive care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug | Single-dose infusion of 8 mg/kg. Maximum dose of 800 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Day 15 of the trial |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | All-cause mortality from randomization to day 28 | 29 days after the randomization |
| Hospital Mortality | Deaths that occur during hospital admission. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 29 days after the randomization |
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:
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| Name | Affiliation | Role |
|---|---|---|
| Viviane C Veiga, MD | Beneficência Portuguesa de Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HCOR -Hospital do Coracao | São Paulo | São Paulo | 04004030 | Brazil | ||
| UNIFESP |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33472855 | Derived | Veiga VC, Prats JAGG, Farias DLC, Rosa RG, Dourado LK, Zampieri FG, Machado FR, Lopes RD, Berwanger O, Azevedo LCP, Avezum A, Lisboa TC, Rojas SSO, Coelho JC, Leite RT, Carvalho JC, Andrade LEC, Sandes AF, Pintao MCT, Castro CG Jr, Santos SV, de Almeida TML, Costa AN, Gebara OCE, de Freitas FGR, Pacheco ES, Machado DJB, Martin J, Conceicao FG, Siqueira SRR, Damiani LP, Ishihara LM, Schneider D, de Souza D, Cavalcanti AB, Scheinberg P; Coalition covid-19 Brazil VI Investigators. Effect of tocilizumab on clinical outcomes at 15 days in patients with severe or critical coronavirus disease 2019: randomised controlled trial. BMJ. 2021 Jan 20;372:n84. doi: 10.1136/bmj.n84. |
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| ID | Term |
|---|---|
| D000080424 | Cytokine Release Syndrome |
| ID | Term |
|---|---|
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
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| OTHER |
| Brazilian Research In Intensive Care Network | NETWORK |
| Hospital Moinhos de Vento | OTHER |
| Brazilian Clinical Research Institute | OTHER |
| Federal University of São Paulo | OTHER |
Prospective, randomized, superiority, open-label, controlled trial. Randomization 1:1 to best supportive care (BSC) versus Tocilizumab + BSC
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| 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 | 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) | 29 days after the randomization (evaluations at D8 and D29) |
| Ventilator free days | Days alive and free from mechanical ventilation since randomization | 29 days after the randomization |
| Time until oxygen support independence | Days from randomization to independence of oxygen support | 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. | 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. | 29 days after the randomization |
| Duration of hospitalization | Lenght of hospitalization stay in survivors (in days) | 29 days after the randomization |
| Other infections | Incidence of other infections (aside from SARS-CoV 2) | 29 days after the randomization |
| Incidence of thromboembolic events | Incidence of thromboembolic events in patients with COVID-19 | 29 days after the randomization |
| Incidence of adverse events | Evaluation of adverse events, as well as serious and unexpected adverse events | 29 days after the randomization (specific evaluations at D8, D15 and D29) |
| 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 |
| 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 | Day 8 and 15 after randomization |
| São Paulo |
| São Paulo |
| Brazil |
| HAOC - Hospital Alemao Oswaldo Cruz | São Paulo | 01323001 | Brazil |
| Beneficência Portuguesa de Sao Paulo | São Paulo | 01323900 | Brazil |
| 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 |
| D012769 | Shock |