Status:
UNKNOWN
Interleukin-6 Antagonists in Critically-ill Covid-19 Patients
Lead Sponsor:
University of Pecs
Conditions:
COVID-19
Critical Illness
Eligibility:
All Genders
18-100 years
Brief Summary
The emerging SARS-COV2 virus has shed a new light on the cross-talks between the immune and the hemostatic system. In this study we aim to evaluate the dynamic change in coagulation caused by the modu...
Detailed Description
The emerging SARS-COV2 virus has shed new light on the cross-talk between the immune and the hemostatic system. Pathophysiologically in COVID-19 infection the thrombo-inflammatory process is initiated...
Eligibility Criteria
Inclusion
- Adults (\>18 years old)
- Clinical diagnosis of SARS-CoV2 infection with rtPCR confirmation
- Disease severity with the indication of immunomodulation therapy with interleukin-6 antagonist: acute respiratory failure that requires invasive, noninvasive ventilation , or high flow nasal oxygen therapy with the following parameters: FiO2 \> 0,4, flow \> 30L/min and C Reactive Protein \> 75 mg/L
Exclusion
- The patient had previously been administered one of the following immunomodulating drug: anakinra, tocilizumab, sarilumab
- Presence of any condition or drug in the medical history that can lead to immunosuppression
- Suspicion of infection (active tuberculosis, bacterial, viral, fungal) or level of procalcitonine higher than 0,5 ng/ml at the enrollment of the patient
- Number of thrombocyte lower than 50 x 109 / L
- More than \>120 hours passed between the admission to the ICU and the administration of interleukin-6 antagonist
- Administration of any of the following drugs the week before or during the study: fibrinolytic therapy, factor products (PCC, ATIII, FVIIa, FXIII), fibrinogen, desmopressin, tranexamic acid, blood products (FFP, thrombocyte concentrate)
- Pregnancy
- The patient or his legal guardian does not sign the consent
Key Trial Info
Start Date :
February 6 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05218369
Start Date
February 6 2022
End Date
December 1 2024
Last Update
April 20 2023
Active Locations (3)
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1
Department of Anaesthesiology and Intensive Therapye, Medical School, University of Pécs
Pécs, Baranya, Hungary, 7624
2
Central Department of Anesthesiology and Intensive Care, Szent György University Teaching Hospital of County Fejér
Székesfehérvár, Fejér, Hungary, 8000
3
Department of Anaesthesiology and Intensive Therapy, Pest Megyei Flór Ferenc Hospital
Kistarcsa, Pest County, Hungary, 2143