COVID-19, Critical Care, Mortality, Tocilizumab
Conditions
Keywords
tocilizumab, COVID-19, Critical Care, Mortality
Brief summary
Although its safety and efficacy in the COVID-19 patient population are still unclear, tocilizumab is one of treatment. Tocilizumab is a U.S. Food and Drug Administration approved IL-6 receptor antagonist widely used to treat CRS secondary to the chimeric antigen receptor T cell. In this study the investigators will evaluate the efficacy of Tocilizumab, an IL-6 antagonist administered in the early period in intensive care patients with COVID-19 pneumonia followed by hypoxic and systemic inflammation is predominant, but who do not support mechanical ventilation.
Detailed description
With this study, the investigators will evaluate the efficacy of Tocilizumab, an IL-6 antagonist administered in the early period in intensive care patients with COVID-19 pneumonia followed by hypoxic and systemic inflammation is predominant, but who do not support mechanical ventilation. With this study, those with signs of hypoxia and systemic inflammation followed by COVID-19 pneumonia (SpO2 \<90% on room air together with the elevation of any two of the systemic inflammatory markers such as CRP, LDH and Ferritin) and / or acute bilateral infiltrates on chest radiograph and tocilizumab the patients who received treatment and those who received standard therapy will be compared. In the study, cases followed up with COVID-19 pneumonia and respiratory failure between March 2020 and March 2021 will be retrospectively evaluated. Tocilizumab was applied as 400 mg - 800 mg iv (depending on weight). A second dose could be given 12-24 h later if the patient's condition had not improved. Primary end point was determined as intensive care mortality.
Interventions
DRUGTocilizumab
400mg or 800 mg IV tocilizumab treatment according to patient clinical severity
Sponsors
Karadeniz Technical University
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients were admitted to intensive care unit, diagnosed with COVID-19 pneumonia
Exclusion criteria
* Patients who require mechanical ventilation in intensive care admission * Cases who received tocilizumab after being intubated during follow-up even though they were not intubated at admission * patients for whom tocilizumab is contraindicated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of intensive care mortality in the groups | 28 Day | all-cause mortality in the patient groups given and not given tocilizumab in the intensive care unit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of needed of mechanical ventilation in the groups | 28 Day | Intubation in tocilizumab or standard therapy group assessed by an event-time analysis. |
Countries
Turkey (Türkiye)
Outcome results
None listed