COVID-19HEMOCOVNCT05218369
Interleukin-6 Antagonists in Critically-ill Covid-19 Patients
An observational study of COVID-19 and Critical Illness, run by University of Pecs at 3 sites in Hungary.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- COVID-19, Critical Illness
- What is being tested?
- IL6 Antagonist
- How many people
- 30 participants
- Where
- 3 sitesHungary
- Study dates
- 6 Feb 2022to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Hungary3 sites, 3 recruiting
- Recruiting
Department of Anaesthesiology and Intensive Therapy, Pest Megyei Flór Ferenc Hospital
Kistarcsa, Pest County, 2143
Zoltán Ruszkai, MD, dr.ruszkai.zoltan@gmail.com
Csanád Geréd, MD, gered.csanad@florhosp.hu
- Recruiting
Department of Anaesthesiology and Intensive Therapye, Medical School, University of Pécs
Pécs, Baranya, 7624
Tamás Kiss, MD, kisstamasaiti@gmail.com
Margit Csata, MD, csata.margit@pte.hu
- Recruiting
Central Department of Anesthesiology and Intensive Care, Szent György University Teaching Hospital of County Fejér
Székesfehérvár, Fejér, 8000
Máté Rottler, MD, mate.rottler@gmail.com
Marcell Virág, MD, viragmarcell@yahoo.com
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19, Critical Illness
- Being tested
- IL6 Antagonist
- Keywords
- severe COVID-19, interleukin-6 antagonist, ClotPro, viscoelastic hemostasis assay
- Medical subject headings
- COVID-19, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IL6 AntagonistDrug
Patients will receive IL-6 antagonist therapy at the consultant's discretion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: IL6 Antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the lysis time
Change of the fibrinolytic system before (T0) and after immunomodulation therapy, measured by the lysis time (LT).
Measured: 48 hours
Change in the lysis onset time
Change of the fibrinolytic system before (T0) and after immunomodulation therapy, measured by the lysis onset time (LOT).
Measured: 48 hours
Secondary outcomes (9)
Change in the lysis time
Change of the fibrinolytic system before (T0) and after immunomodulation therapy, measured by the lysis time (LT).
Measured: 24 hours and 7 days
Change in the lysis onset time
Change of the fibrinolytic system before (T0) and after immunomodulation therapy, measured by the lysis onset time (LOT).
Measured: 24 hours and 7 days
Change in Clotpro assay
Change in blood coagulation parameters which evaluate hypercoagulable state before (T0) and after immunomodulation therapy (T1,2,3) measured by Clotpro device assays.
Measured: 24 hours, 48 hours, and 7 days
Correlation between procalcitonin and Clotpro
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.
Measured: 24 hours, 48 hours, and 7 days
Correlation between C reactive protein and Clotpro
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.
Measured: 24 hours, 48 hours, and 7 days
Correlation between ferritin and Clotpro
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.
Measured: 24 hours, 48 hours, and 7 days
Correlation between lactate dehydrogenase and Clotpro
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.
Measured: 24 hours, 48 hours, and 7 days
Correlation between syndecan-1 and Clotpro
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.
Measured: 24 hours, 48 hours, and 7 days
Correlation between thrombomodulin and Clotpro
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.
Measured: 24 hours, 48 hours, and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start6 Feb 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218369
- Sponsor's protocol ID
- 1405-3/2022/EÜIG
- Acronym
- HEMOCOV
- Status last verified
- Apr 2023
- First submitted
- 29 Jan 2022
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be presented at conferences and in the results part of the article.
Publications
Gupta A, Madhavan MV, Sehgal K, Nair N, Mahajan S, Sehrawat TS, Bikdeli B, Ahluwalia N, Ausiello JC, Wan EY, Freedberg DE, Kirtane AJ, Parikh SA, Maurer MS, Nordvig AS, Accili D, Bathon JM, Mohan S, Bauer KA, Leon MB, Krumholz HM, Uriel N, Mehra MR, Elkind MSV, Stone GW, Schwartz A, Ho DD, Bilezikian JP, Landry DW. Extrapulmonary manifestations of COVID-19. Nat Med. 2020 Jul;26(7):1017-1032. doi: 10.1038/s41591-020-0968-3. Epub 2020 Jul 10.
PubMed 32651579Jackson SP, Darbousset R, Schoenwaelder SM. Thromboinflammation: challenges of therapeutically targeting coagulation and other host defense mechanisms. Blood. 2019 Feb 28;133(9):906-918. doi: 10.1182/blood-2018-11-882993. Epub 2019 Jan 14.
PubMed 30642917Levy JH, Iba T, Olson LB, Corey KM, Ghadimi K, Connors JM. COVID-19: Thrombosis, thromboinflammation, and anticoagulation considerations. Int J Lab Hematol. 2021 Jul;43 Suppl 1(Suppl 1):29-35. doi: 10.1111/ijlh.13500.
PubMed 34288441Tang N, Li D, Wang X, Sun Z. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost. 2020 Apr;18(4):844-847. doi: 10.1111/jth.14768. Epub 2020 Mar 13.
PubMed 32073213Levi M, Thachil J, Iba T, Levy JH. Coagulation abnormalities and thrombosis in patients with COVID-19. Lancet Haematol. 2020 Jun;7(6):e438-e440. doi: 10.1016/S2352-3026(20)30145-9. Epub 2020 May 11. No abstract available.
PubMed 32407672Bester J, Pretorius E. Effects of IL-1beta, IL-6 and IL-8 on erythrocytes, platelets and clot viscoelasticity. Sci Rep. 2016 Aug 26;6:32188. doi: 10.1038/srep32188.
PubMed 27561337Tleyjeh IM, Kashour Z, Damlaj M, Riaz M, Tlayjeh H, Altannir M, Altannir Y, Al-Tannir M, Tleyjeh R, Hassett L, Kashour T. Efficacy and safety of tocilizumab in COVID-19 patients: a living systematic review and meta-analysis. Clin Microbiol Infect. 2021 Feb;27(2):215-227. doi: 10.1016/j.cmi.2020.10.036. Epub 2020 Nov 5.
PubMed 33161150Kovacs EH, Rottler M, Ruszkai Z, Gered C, Kiss T, Csata M, Reger B, Jakabfi-Csepregi R, Papp I, Turan C, Hegyi P, Fazakas J, Molnar Z, Tanczos K. Exploratory Analysis of Coagulation and Fibrinolysis Trajectories After IL-6 Antagonist Therapy in COVID-19: A Case Series. Biomedicines. 2026 Jan 22;14(1):254. doi: 10.3390/biomedicines14010254.
PubMed 41595788Kovacs EH, Rottler M, Dembrovszky F, Ocskay K, Szabo L, Hegyi P, Molnar Z, Tanczos K. Investigating the association between IL-6 antagonist therapy and blood coagulation in critically ill patients with COVID-19: a protocol for a prospective, observational, multicentre study. BMJ Open. 2022 Nov 4;12(11):e063856. doi: 10.1136/bmjopen-2022-063856.
PubMed 36332964
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Immunomodulation With Interleukin-6 Antagonists on the Coagulation System in Critically-ill Covid-19 Patients
- ClinicalTrials.gov ID
- NCT05218369
- Acronym / sponsor ID
- HEMOCOV / 1405-3/2022/EÜIG
- Conditions
- COVID-19, Critical Illness
- Keywords
- severe COVID-19, interleukin-6 antagonist, ClotPro, viscoelastic hemostasis assay
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 6 Feb 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill COVID-19 patients | – | Drug: IL6 AntagonistPatients 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IL6 AntagonistPatients will receive IL-6 antagonist therapy at the consultant's discretion. | Drug | Critically ill COVID-19 patients |
Primary outcome
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).
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).
9 secondary outcomes
Change in the lysis time
Time frame: 24 hours and 7 days
Change in the lysis onset time
Time frame: 24 hours and 7 days
Change in Clotpro assay
Time frame: 24 hours, 48 hours, and 7 days
Correlation between procalcitonin and Clotpro
Time frame: 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 ferritin and Clotpro
Time frame: 24 hours, 48 hours, and 7 days
Correlation between lactate dehydrogenase and Clotpro
Time frame: 24 hours, 48 hours, and 7 days
Correlation between syndecan-1 and Clotpro
Time frame: 24 hours, 48 hours, and 7 days
Correlation between thrombomodulin and Clotpro
Time frame: 24 hours, 48 hours, and 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Background: PubMed 32651579Gupta A, Madhavan MV, Sehgal K, Nair N, Mahajan S, Sehrawat TS, Bikdeli B, Ahluwalia N, Ausiello JC, Wan EY, Freedberg DE, Kirtane AJ, Parikh SA, Maurer MS, Nordvig AS, Accili D, Bathon JM, Mohan S, Bauer KA, Leon MB, Krumholz HM, Uriel N, Mehra MR, Elkind MSV, Stone GW, Schwartz A, Ho DD, Bilezikian JP, Landry DW. Extrapulmonary manifestations of COVID-19. Nat Med. 2020 Jul;26(7):1017-1032. doi: 10.1038/s41591-020-0968-3. Epub 2020 Jul 10.
- Background: PubMed 30642917Jackson SP, Darbousset R, Schoenwaelder SM. Thromboinflammation: challenges of therapeutically targeting coagulation and other host defense mechanisms. Blood. 2019 Feb 28;133(9):906-918. doi: 10.1182/blood-2018-11-882993. Epub 2019 Jan 14.
- Background: PubMed 34288441Levy JH, Iba T, Olson LB, Corey KM, Ghadimi K, Connors JM. COVID-19: Thrombosis, thromboinflammation, and anticoagulation considerations. Int J Lab Hematol. 2021 Jul;43 Suppl 1(Suppl 1):29-35. doi: 10.1111/ijlh.13500.
- Background: PubMed 32073213Tang N, Li D, Wang X, Sun Z. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost. 2020 Apr;18(4):844-847. doi: 10.1111/jth.14768. Epub 2020 Mar 13.
- Background: PubMed 32407672Levi M, Thachil J, Iba T, Levy JH. Coagulation abnormalities and thrombosis in patients with COVID-19. Lancet Haematol. 2020 Jun;7(6):e438-e440. doi: 10.1016/S2352-3026(20)30145-9. Epub 2020 May 11. No abstract available.
- Background: PubMed 27561337Bester J, Pretorius E. Effects of IL-1beta, IL-6 and IL-8 on erythrocytes, platelets and clot viscoelasticity. Sci Rep. 2016 Aug 26;6:32188. doi: 10.1038/srep32188.
- Background: PubMed 33161150Tleyjeh IM, Kashour Z, Damlaj M, Riaz M, Tlayjeh H, Altannir M, Altannir Y, Al-Tannir M, Tleyjeh R, Hassett L, Kashour T. Efficacy and safety of tocilizumab in COVID-19 patients: a living systematic review and meta-analysis. Clin Microbiol Infect. 2021 Feb;27(2):215-227. doi: 10.1016/j.cmi.2020.10.036. Epub 2020 Nov 5.
- Derived from this study: PubMed 41595788Kovacs EH, Rottler M, Ruszkai Z, Gered C, Kiss T, Csata M, Reger B, Jakabfi-Csepregi R, Papp I, Turan C, Hegyi P, Fazakas J, Molnar Z, Tanczos K. Exploratory Analysis of Coagulation and Fibrinolysis Trajectories After IL-6 Antagonist Therapy in COVID-19: A Case Series. Biomedicines. 2026 Jan 22;14(1):254. doi: 10.3390/biomedicines14010254.
- Derived from this study: PubMed 36332964Kovacs EH, Rottler M, Dembrovszky F, Ocskay K, Szabo L, Hegyi P, Molnar Z, Tanczos K. Investigating the association between IL-6 antagonist therapy and blood coagulation in critically ill patients with COVID-19: a protocol for a prospective, observational, multicentre study. BMJ Open. 2022 Nov 4;12(11):e063856. doi: 10.1136/bmjopen-2022-063856.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data will be presented at conferences and in the results part of the article.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Critical Illness, run by University of Pecs at 3 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Péter Hegyi, MD, PhD, Dsc, MAE (+3672/536-246, p.hegyi@tm-centre.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the lysis time (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05218369, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.