Effect of Tocilizumab on Intensive Care Patients With COVID-19 Pneumonia, a Retrospective Cohort Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Tocilizumab treatment group Symptoms of hypoxia and systemic inflammation (SpO2 <90% on room air with accompanying elevation of any two of the systemic inflammatory markers such as CRP, LDH and Ferritin) and / or acute bilateral infiltrations on chest radiography or rapid progression of existing infiltrations, but who did not need mechanical ventilation at admission and were given tocilizumab treatment. |
Drug: Tocilizumab
400mg or 800 mg IV tocilizumab treatment according to patient clinical severity
|
| Standard treatment group Patients who did not require mechanical ventilation in intensive care admission and did not receive tocilizumab treatment during any period of hospitalization. |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Rates of needed of mechanical ventilation in the groups [28 Day]
Intubation in tocilizumab or standard therapy group assessed by an event-time analysis.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Karadeniz Technical University | Trabzon | Turkey | 61080 |
Sponsors and Collaborators
- Karadeniz Technical University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021/24
- 2021-01-24T17_19_44