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.
Drug: Tocilizumab
Single-dose infusion of 8 mg/kg. Maximum dose of 800 mg.
Other Name: Actemra
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
UNIFESP
São Paulo, Sao Paulo, Brazil
HCOR -Hospital do Coracao
Sao Paulo, SP, Brazil
HAOC - Hospital Alemao Oswaldo Cruz
Sao Paulo, Brazil
Beneficência Portuguesa de Sao Paulo
Sao Paulo, Brazil
HAOC - Hospital Alemao Oswaldo Cruz - unidade Vergueiro
Sao Paulo, Brazil
HIAE - Hospital Israelita Albert Einstein
Sao Paulo, Brazil
HSL - Hospital Sírio Libanês
Sao Paulo, Brazil
Viviane C Veiga, MD, Principal Investigator
Beneficência Portuguesa de Sao Paulo