Interleukin-6 Antagonists in Critically-ill Covid-19 Patients (HEMOCOV)

April 18, 2023 updated by: University of Pecs

Effects of Immunomodulation With Interleukin-6 Antagonists on the Coagulation System in Critically-ill Covid-19 Patients

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 modulation of the inflammatory response by interleukin-6 antagonist as assessed by viscoelastic methods in critically ill COVID-19 patients. Furthermore we try to draw attention to possible associations between the endothelial cell injury, inflammation and coagulation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 by the host's exaggerated systemic inflammatory response, also called "dysregulated immune response" that activates both the inflammatory and the coagulation cascade directly by inflammatory mediators and indirectly by causing endothelial cell injury. These mechanisms altogether contribute to the imbalance of the hemostasis that is characterized by a procoagulant state.

In this multicenter prospective observational study, we aim to evaluate the dynamic change in coagulation as a result of immunomodulation by interleukin-6 antagonists in critically ill COVID-19 patients. We will assess the hemostatic system by a viscoelastic hemostasis assay (Clotpro, Haemonetics Corporation, Boston). Furthermore, we try to draw attention to possible associations between endothelial cell injury, inflammation, and coagulation. To compare these parameters we will draw blood for analysis before administration of IL-6 antagonist then 24h after, 48h after, and 7 days after.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hungary
    • Baranya
      • Pécs, Baranya, Hungary, 7624
        • Recruiting
        • Department of Anaesthesiology and Intensive Therapye, Medical School, University of Pécs
        • Contact:
        • Contact:
    • Fejér
      • Székesfehérvár, Fejér, Hungary, 8000
        • Recruiting
        • Central Department of Anesthesiology and Intensive Care, Szent György University Teaching Hospital of County Fejér
        • Contact:
        • Contact:
    • Pest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 96 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All adult patients admitted to intensive care units (ICUs) requiring mechanical ventilation with proven COVID-19 infection and treated with interleukin-6 antagonist therapy.

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Critically ill COVID-19 patients
Patients in ICU due to critical COVID-19 infection, who receive early (within the first 24 hours, but no later than 48 hours after intubation) IL-6 antagonist therapy at the consultant's discretion.
Drug: IL6 Antagonist
Patients will receive IL-6 antagonist therapy at the consultant's discretion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the lysis time
Time Frame: 48 hours
Change of the fibrinolytic system before (T0) and after immunomodulation therapy, measured by the lysis time (LT).
48 hours
Change in the lysis onset time
Time Frame: 48 hours
Change of the fibrinolytic system before (T0) and after immunomodulation therapy, measured by the lysis onset time (LOT).
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the lysis time
Time Frame: 24 hours and 7 days
Change of the fibrinolytic system before (T0) and after immunomodulation therapy, measured by the lysis time (LT).
24 hours and 7 days
Change in the lysis onset time
Time Frame: 24 hours and 7 days
Change of the fibrinolytic system before (T0) and after immunomodulation therapy, measured by the lysis onset time (LOT).
24 hours and 7 days
Change in Clotpro assay
Time Frame: 24 hours, 48 hours, and 7 days
Change in blood coagulation parameters which evaluate hypercoagulable state before (T0) and after immunomodulation therapy (T1,2,3) measured by Clotpro device assays.
24 hours, 48 hours, and 7 days
Correlation between procalcitonin and Clotpro
Time Frame: 24 hours, 48 hours, and 7 days
Correlation between inflammatory and blood coagulation parameters. For the assessment of this endpoint, we will use the results of the inflammatory laboratory parameters as procalcitonin and the blood coagulation parameters measured by the Clotpro.
24 hours, 48 hours, and 7 days
Correlation between C reactive protein and Clotpro
Time Frame: 24 hours, 48 hours, and 7 days
Correlation between inflammatory and blood coagulation parameters. For the assessment of this endpoint, we will use the results of the inflammatory laboratory parameters as C reactive protein and the blood coagulation parameters measured by the Clotpro.
24 hours, 48 hours, and 7 days
Correlation between ferritin and Clotpro
Time Frame: 24 hours, 48 hours, and 7 days
Correlation between inflammatory and blood coagulation parameters. For the assessment of this endpoint, we will use the results of the inflammatory laboratory parameters as ferritin and the blood coagulation parameters measured by the Clotpro.
24 hours, 48 hours, and 7 days
Correlation between lactate dehydrogenase and Clotpro
Time Frame: 24 hours, 48 hours, and 7 days
Correlation between inflammatory and blood coagulation parameters. For the assessment of this endpoint, we will use the results of the inflammatory laboratory parameters as lactate dehydrogenase and the blood coagulation parameters measured by the Clotpro.
24 hours, 48 hours, and 7 days
Correlation between syndecan-1 and Clotpro
Time Frame: 24 hours, 48 hours, and 7 days
Correlation between biomarkers of endothelial injury and blood coagulation parameters. For the assessment of this endpoint, we will use the results of the biomarkers of the endothelial damage as syndecan-1 and the blood coagulation parameters measured by the Clotpro.
24 hours, 48 hours, and 7 days
Correlation between thrombomodulin and Clotpro
Time Frame: 24 hours, 48 hours, and 7 days
Correlation between biomarkers of endothelial injury and blood coagulation parameters. For the assessment of this endpoint, we will use the results of the biomarkers of the endothelial damage as thrombomodulin and the blood coagulation parameters measured by the Clotpro.
24 hours, 48 hours, and 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pecs

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

January 29, 2022

First Submitted That Met QC Criteria

January 29, 2022

First Posted (Actual)

February 1, 2022

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1405-3/2022/EÜIG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be presented at conferences and in the results part of the article.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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