sing Tocilizumab in critically ill patients with COVID-19.
Phase 4
Recruiting
- Conditions
- Coronaviruses infectionsC01.925.782.600.550.200
- Registration Number
- RBR-3zdynp
- Lead Sponsor
- Victor Côrtes Pourchet de Carvalho
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
COVID-19 disease with more than seven (7) days of symptoms plus two of the following criteria:
1- Fever (axillary temperature greater than or equal to 38 degrees centigrade)
2- D-dimer greater than 1000 or elevated PCR-t or IL-6.
3- Ventilatory deterioration or gas exchange or need for ventilatory support (non-invasive or mechanical ventilation)
Exclusion Criteria
Primary or secondary immunodeficiency. Use of immunosuppressive drugs. Under 18 years old. Pregnancy. Symptoms of less than seven (7) days. Absence of respiratory symptoms. End-of-life care.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate the reduction of in-hospital mortality in D28 by 10% before and after intervention using a non-parametric test
- Secondary Outcome Measures
Name Time Method Evaluate by means of a non-parametric test the increase with the intervention of at least 5 days of survival without mechanical ventilation (that is, days without ventilation) until D28. Days without ventilation are defined as the number of days alive and free from mechanical ventilation from the day of analysis to day 28th;Assess the reduction of the need for hemodialysis by at least 20% up to D28 before and after intervention by means of a non-parametric test