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

NCT ID: NCT04893031

Last Updated: 2021-05-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 213 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2021-04-01

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.

Conditions

Tocilizumab; COVID-19; Critical Care; Mortality

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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.

Tocilizumab

Intervention Type: DRUG

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.

No interventions assigned to this group

Interventions

Tocilizumab

400mg or 800 mg IV tocilizumab treatment according to patient clinical severity

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karadeniz Technical University

OTHER

Sponsor Role: lead

Responsible Party

Mehtap Pehlivanlar Küçük

Assistant professor, Colsuntant Intensivist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Karadeniz Technical University

Trabzon, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2021-01-24T17_19_44

Identifier Type: OTHER

Identifier Source: secondary_id

2021/24

Identifier Type: -

Identifier Source: org_study_id