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

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