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

  • STATUS
    Recruiting
  • participants needed
    150
  • sponsor
    Beneficência Portuguesa de São Paulo
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Updated on 5 August 2020
See if I qualify
ct scan
inflammatory response
mechanical ventilation
interleukin-6
x-rays
pneumonia
d-dimer
covid-19
chest x-ray
SARS
tocilizumab
oxygen supplementation
lactate dehydrogenase
cytokine release syndrome
acute respiratory syndrome (sars)

Summary

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.

Description

Coalition VI (TOCIBRS) 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.

Details
Condition COVID, Cytokine Release Syndrome, SARS Pneumonia
Age 18years - 100years
Treatment Tocilizumab
Clinical Study IdentifierNCT04403685
SponsorBeneficência Portuguesa de São Paulo
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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
D-dimer > 1,000 ng/mL
Reactive C protein > 5 mg/dL
Ferritin > 300 mg/dL
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
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ct scan
inflammatory response
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x-rays
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d-dimer
covid-19
chest x-ray
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tocilizumab
oxygen supplementation
lactate dehydrogenase
cytokine release syndrome
acute respiratory syndrome (sars)

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