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

Karadeniz Technical University

Status: Completed

Conditions: Mortality; COVID-19; Critical Care; Tocilizumab

Treatments: Drug: Tocilizumab

Study type: Observational

Funder types: Other

Identifiers

NCT04893031

2021/24

2021-01-24T17_19_44 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 213 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

213 participants in 2 patient groups

Tocilizumab treatment group

Description:

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.

Treatment:

Drug: Tocilizumab

Standard treatment group

Description:

Patients who did not require mechanical ventilation in intensive care admission and did not receive tocilizumab treatment during any period of hospitalization.