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

Completed

• Conditions: Tocilizumab; Mortality; Critical Care; COVID-19
• Interventions: Drug: Tocilizumab

• Registration Number: NCT04893031
• Lead Sponsor: Karadeniz Technical University

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.

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2021-03-01
• Study Completion: 2021-04-01
• Status Verified: 2021-05
• Study First Submitted: 2021-05-10
• Study First Submitted QC: 2021-05-10
• Last Update Submitted: 2021-05-18
• Study First Posted: 2021-05-19
• Last Update Posted: 2021-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tocilizumab treatment group	Tocilizumab	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Rates of needed of mechanical ventilation in the groups	28 Day	Intubation in tocilizumab or standard therapy group assessed by an event-time analysis.

Trial Locations

Locations (1)

Karadeniz Technical University; 🇹🇷 Trabzon, Turkey