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

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ClinicalTrials.gov Identifier: NCT05218369
Recruitment Status : Not yet recruiting
First Posted : February 1, 2022
Last Update Posted : February 1, 2022
Sponsor:
Information provided by (Responsible Party):
University of Pecs

Study Description
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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 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.

Condition or disease Intervention/treatment
COVID-19 Critical Illness Drug: IL6 Antagonist

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 Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Immunomodulation With Interleukin-6 Antagonists on the Coagulation System in Critically-ill Covid-19 Patients
Estimated Study Start Date : February 1, 2022
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05218369


Contacts
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Contact: Péter Hegyi, MD, PhD, Dsc, MAE +3672/536-246 p.hegyi@tm-centre.org
Contact: Szilárd Váncsa, MD +3672/536-246 vancsaszilard@gmail.com

Sponsors and Collaborators
University of Pecs
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Pecs
ClinicalTrials.gov Identifier: NCT05218369    
Other Study ID Numbers: 1405-3/2022/EÜIG
First Posted: February 1, 2022    Key Record Dates
Last Update Posted: February 1, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be presented at conferences and in the results part of the article.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Pecs:
severe COVID-19
interleukin-6 antagonist
ClotPro
viscoelastic hemostasis assay
Additional relevant MeSH terms:
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COVID-19
Critical Illness
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes