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

• Status: Terminated
• Trial end date: 2020-07-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beneficência Portuguesa de São Paulo
• Collaborators: Brazilian Clinical Research Institute; Brazilian Research In Intensive Care Network; Federal University of São Paulo; Hospital Alemão Oswaldo Cruz; Hospital do Coracao; Hospital Israelita Albert Einstein; Hospital Moinhos de Vento; Hospital Sirio-Libanes

Criteria

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