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

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.

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Key information

Conditions

Tocilizumab COVID-19 Coronaviridae Infections Coronavirus Infections Critical Care Infections Lung Diseases Mortality Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karadeniz Technical University

Trabzon, 61080, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tocilizumab

Drug

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

Primary outcomes

Rates of intensive care mortality in the groups

Time frame: 28 Day

all-cause mortality in the patient groups given and not given tocilizumab in the intensive care unit.

Secondary outcomes

Rates of needed of mechanical ventilation in the groups

Time frame: 28 Day

Intubation in tocilizumab or standard therapy group assessed by an event-time analysis.

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: May 19, 2021
Registry last updated: May 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed