Effect of Tocilizumab on Intensive Care Patients With COVID-19 Pneumonia, a Retrospective Cohort Study

COVID-19 Clinical Trial

Official title:

Effect of Tocilizumab on Intensive Care Patients With COVID-19 Pneumonia, a Retrospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04893031
• Other study ID #: 2021/24
• Secondary ID: 2021-01-24T17_19
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: May 2021
• Source: Karadeniz Technical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: April 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Critical Care
• Mortality
• Pneumonia
• Tocilizumab

Intervention

Drug:
• Tocilizumab
400mg or 800 mg IV tocilizumab treatment according to patient clinical severity

Locations

Country	Name	City	State
Turkey	Karadeniz Technical University	Trabzon

Sponsors (1)

Lead Sponsor	Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of intensive care mortality in the groups	all-cause mortality in the patient groups given and not given tocilizumab in the intensive care unit.	28 Day
Secondary	Rates of needed of mechanical ventilation in the groups	Intubation in tocilizumab or standard therapy group assessed by an event-time analysis.	28 Day