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Using Tocilizumab in critically ill patients with COVID-19.

Clinical Characterisation Protocol for Severe Emerging Infections ISARIC/WHO: COVID-19

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-3zdynp
Enrollment
Unknown
Registered
2020-06-23
Start date
2020-03-16
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronaviruses infections

Interventions

Sixty individuals with coronavirus infection who meet the inclusion criteria for the study will receive standard intensive care and organic support therapy, as per clinical assessment (eg oxygen thera
Drug

Sponsors

Victor Côrtes Pourchet de Carvalho
Lead Sponsor
Hospital Niterói D´Or
Collaborator

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Evaluate the reduction of in-hospital mortality in D28 by 10% before and after intervention using a non-parametric test

Secondary

MeasureTime frame
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

Countries

Brazil

Contacts

Public ContactVictor de Carvalho

Hospital Universitário Antônio Pedro

torcortes@yahoo.com.br552126299254

Outcome results

None listed

Source: REBEC (via WHO ICTRP)