Status:
TERMINATED
Safety and Efficacy of Tocilizumab in Moderate to Severe COVID-19 With Inflammatory Markers
Lead Sponsor:
Beneficência Portuguesa de São Paulo
Collaborating Sponsors:
Hospital do Coracao
Hospital Israelita Albert Einstein
Conditions:
COVID
SARS Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 inflam...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2020
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT04403685
Start Date
May 8 2020
End Date
July 21 2020
Last Update
August 26 2020
Active Locations (7)
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1
HCOR -Hospital do Coracao
São Paulo, São Paulo, Brazil, 04004030
2
UNIFESP
São Paulo, São Paulo, Brazil
3
HAOC - Hospital Alemao Oswaldo Cruz
São Paulo, Brazil, 01323001
4
Beneficência Portuguesa de Sao Paulo
São Paulo, Brazil, 01323900