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Safety and Efficacy of Tocilizumab in Moderate to Severe COVID-19 With Inflammatory Markers (TOCIBRAS)

B

Beneficência Portuguesa de São Paulo

Status and phase

Terminated
Phase 3

Conditions

Cytokine Release Syndrome
COVID
SARS Pneumonia

Treatments

Drug: Tocilizumab

Study type

Interventional

Funder types

Other
NETWORK

Identifiers

NCT04403685
TOCIBRAS

Details and patient eligibility

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

129 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy 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

    1. Need for oxygen supplementation to keep SPO2 > 93% OR need for mechanical ventilation for less than 24 hours before the randomization

    2. At least two of the following inflammatory tests above the cutoff :

      1. D-dimer > 1,000 ng/mL
      2. Reactive C protein > 5 mg/dL
      3. Ferritin > 300 mg/dL
      4. Lactate dehydrogenase > upper level limit

Exclusion criteria

  • Need for mechanical ventilation for 24 hours or more before the randomization
  • Hypersensitivity to tocilizumab
  • Patients without therapeutic perspective or in palliative care
  • Active non controlled infections
  • Other clinical conditions that contraindicate tocilizumab, according to the assistant physician
  • Low neutrophils count (< 0.5 x 109/L)
  • Low platelets count (< 50 x 109/L)
  • Liver disease, cirrhosis or elevated AST or ALT above 5 times the upper level limit
  • Renal disease with estimate glomerular filtration below 30 mL/min/1.72 m2 (MDRD or CKD-EPI scores)
  • Active diverticulitis
  • Breastfeeding women
  • Pregnancy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

129 participants in 2 patient groups

Tocilizumab
Experimental group
Description:
Single-dose tocilizumab of 8 mg/kg (maximum dose of 800mg). Best supportive care.
Treatment:
Drug: Tocilizumab
Control arm
No Intervention group
Description:
Best supportive care.

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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