An observational study in Tocilizumab, COVID-19 and Critical Care, sponsored by Karadeniz Technical University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-20.
Sponsored by Karadeniz Technical University · Observational
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.
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.
7,641 studies on the registry are indexed under COVID-19; 487 are open to participants now.
This study's enrollment of 213 is below the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Karadeniz Technical University is the lead sponsor of 145 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients were diagnosed with COVID-19 and were admitted to intensive care unit
Exclusion Criteria:
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.
Drug: Tocilizumab
Patients who did not require mechanical ventilation in intensive care admission and did not receive tocilizumab treatment during any period of hospitalization.
400mg or 800 mg IV tocilizumab treatment according to patient clinical severity
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.
Time frame: 28 Day
Rates of needed of mechanical ventilation in the groups
Intubation in tocilizumab or standard therapy group assessed by an event-time analysis.
Time frame: 28 Day
Plan to share: Yes — Data can be shared with researchers if contact with corresponded.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Karadeniz Technical University