Venous ThromboembolismNCT05143567
Hemostasis and Inflammation in COVID-19 Patients With Venous and Arterial Thrombotic Complications
A study of Venous Thromboembolism and covid19, run by Ryazan State Medical University at 1 site in Russia.
Trial summary
The study is aimed at assessing the role of the activity of high-risk markers of thrombotic events (MCP-1, MIP1α, IP-10, phosphatedylserine, calreticulin) on the development of thrombotic complications in patients with COVID -19. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Venous Thromboembolism, covid19, Thrombosis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteRussia
- Study dates
- 1 Nov 2021to 23 Jul 2023
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men or women over 18 years of age with a new coronavirus infection, confirmed by polymerase chain reaction (PCR) studies and chest CT.
Who cannot join
- men or women under 18 years of age; active cancer or a remission period of less than 5 years; decompensated somatic pathology; pregnancy or breastfeeding in women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comprehensive Assessment of the Hemostasis and Inflammation in Patients With Venous and Arterial Thrombotic Complications in Treatment of New Coronaviral Infection (COVID-19)
The study is aimed at assessing the role of the activity of high-risk markers of thrombotic events (MCP-1, MIP1α, IP-10, phosphatedylserine, calreticulin) on the development of thrombotic complications in patients with COVID -19.
Read the detailed description
The study is aimed at assessing the role of the activity of high-risk markers for thrombotic events (monocytic chemoattractant protein 1 (MCP-1), macrophage inflammatory protein 1α (MIP1α), interferon-induced gamma protein-10 (IP-10), platelet apoptosis markers (phosphatedylserine, calreticulin) on the development of thrombotic complications in patients with COVID -19.
The study will include 150 patients of similar age, gender, and ethnicity, and they will be divided into three groups: Group I: 50 patients with confirmed coronavirus infection without thrombotic complications; Group II: 50 patients with confirmed coronavirus infection with thrombotic complications confirmed by ultrasonography without the use of pharmacomechanical prophylaxis of VTE; Group III: 50 patients with confirmed coronavirus infection with ultrasound-confirmed thrombosis of the deep and saphenous veins of the lower extremities using pharmacomechanical prophylaxis of VTE
- Conditions
- Venous Thromboembolism, covid19, Thrombosis
- Being tested
- standard of care anticoagulation in absence of thrombotic complications, standard of care anticoagulation in presence of thrombotic complications, standard of care anticoagulation in combination with elastic compression
- Keywords
- venous thromboembolism, VTE, thrombotic events, coronavirus, COVID-19, hemostasis, platelet function
- Medical subject headings
- Venous Thromboembolism, COVID-19, Thrombosis, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard of care anticoagulation in absence of thrombotic complicationsOther
Subgroup IA - patients receive UFH (heparin, 7500 Units 2-3 times daily) for the prevention or treatment of VTE Subgroup IB - patients receive LMWH (enoxaparin) for the prevention or treatment of VTE Subgroup IC - patients receive oral anticoagulants (rivaroxaban 10mg QD) for the prevention or treatment of VTE
standard of care anticoagulation in presence of thrombotic complicationsOther
Subgroup IIA - patients receive UFH (heparin, 7500 Units 2-3 times daily) for the prevention or treatment of VTE Subgroup IIB - patients receive LMWH (enoxaparin, 0.4ml 2 times daily) for the prevention or treatment of VTE Subgroup IIC - patients receive oral anticoagulants (rivaroxaban 10mg QD) for the prevention or treatment of VTE
standard of care anticoagulation in combination with elastic compressionOther
Subgroup IIIA - patients receive UFH (heparin, 7500 Units 2-3 times daily) in combination with class II elastic compression (compression stockings above the level of the knee) for the prevention or treatment of VTE Subgroup IIIB - patients receive LMWH (enoxaparin, 0.4ml 2 times daily) in combination with class II elastic compression (compression stockings above the level of the knee) for the prevention or treatment of VTE Subgroup IIIC - patients receive oral anticoagulants (rivaroxaban 10mg QD) in combination with class II elastic compression (compression stockings above the level of the knee) for the prevention or treatment of VTE
| Study group | Role | What they receive |
|---|---|---|
| patients with COVID-19 without thrombotic complications | Experimental | Group I: 50 patients with confirmed coronavirus infection without thrombotic complications Receives: Other: standard of care anticoagulation in absence of thrombotic complications |
| patients with COVID-19 and VTE who received pharmacological prophylaxis of VTE | Experimental | Group II: 50 patients with confirmed coronavirus infection with thrombotic complications confirmed by ultrasonography with pharmacological prophylaxis of VTE Receives: Other: standard of care anticoagulation in presence of thrombotic complications |
| patients with COVID-19 and VTE who received pharmacomechanical prophylaxis of VTE | Experimental | Group III: 50 patients with confirmed coronavirus infection with ultrasound-confirmed thrombosis of the deep and saphenous veins of the lower extremities using pharmacomechanical prophylaxis of VTE. Receives: Other: standard of care anticoagulation in combination with elastic compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
lethal outcomes
Measured: one year
venous thrombosis or pulmonary embolism
a VTE event
Measured: one year
arterial thrombosis
thrombosis of main arteries of the extremities or myocardial infarction or stroke
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start1 Nov 2021
- Primary completion23 Jul 2023
- Study completion23 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Open-label cohort longitudinal study
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ryazan State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agapov Andrey Borisovich, Ryazan State Medical University
- Investigators
- Igor Suchkov, MD, PhD, Study chair, Ryazan State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143567
- Sponsor's protocol ID
- 11.10.2021
- Status last verified
- Nov 2023
- First submitted
- 20 Nov 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Assessment of the Hemostasis and Inflammation in Patients With Venous and Arterial Thrombotic Complications in Treatment of New Coronaviral Infection (COVID-19)
- ClinicalTrials.gov ID
- NCT05143567
- Acronym / sponsor ID
- 11.10.2021
- Conditions
- Venous Thromboembolism, covid19, Thrombosis
- Keywords
- venous thromboembolism, VTE, thrombotic events, coronavirus, COVID-19, hemostasis, platelet function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ryazan State Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 23 Jul 2023 (actual)
- Study completion
- 23 Jul 2023 (actual)
- First posted
- 3 Dec 2021 (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 study is aimed at assessing the role of the activity of high-risk markers of thrombotic events (MCP-1, MIP1α, IP-10, phosphatedylserine, calreticulin) on the development of thrombotic complications in patients with COVID -19.
Detailed description
The study is aimed at assessing the role of the activity of high-risk markers for thrombotic events (monocytic chemoattractant protein 1 (MCP-1), macrophage inflammatory protein 1α (MIP1α), interferon-induced gamma protein-10 (IP-10), platelet apoptosis markers (phosphatedylserine, calreticulin) on the development of thrombotic complications in patients with COVID -19.
The study will include 150 patients of similar age, gender, and ethnicity, and they will be divided into three groups: Group I: 50 patients with confirmed coronavirus infection without thrombotic complications; Group II: 50 patients with confirmed coronavirus infection with thrombotic complications confirmed by ultrasonography without the use of pharmacomechanical prophylaxis of VTE; Group III: 50 patients with confirmed coronavirus infection with ultrasound-confirmed thrombosis of the deep and saphenous veins of the lower extremities using pharmacomechanical prophylaxis of VTE
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Open-label cohort longitudinal study
| Arm | Type | Receives |
|---|---|---|
| patients with COVID-19 without thrombotic complications | Experimental | Other: standard of care anticoagulation in absence of thrombotic complicationsGroup I: 50 patients with confirmed coronavirus infection without thrombotic complications |
| patients with COVID-19 and VTE who received pharmacological prophylaxis of VTE | Experimental | Other: standard of care anticoagulation in presence of thrombotic complicationsGroup II: 50 patients with confirmed coronavirus infection with thrombotic complications confirmed by ultrasonography with pharmacological prophylaxis of VTE |
| patients with COVID-19 and VTE who received pharmacomechanical prophylaxis of VTE | Experimental | Other: standard of care anticoagulation in combination with elastic compressionGroup III: 50 patients with confirmed coronavirus infection with ultrasound-confirmed thrombosis of the deep and saphenous veins of the lower extremities using pharmacomechanical prophylaxis of VTE. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- men or women over 18 years of age with a new coronavirus infection, confirmed by polymerase chain reaction (PCR) studies and chest CT.
Key exclusion criteria (1 listed)
- men or women under 18 years of age; active cancer or a remission period of less than 5 years; decompensated somatic pathology; pregnancy or breastfeeding in women.
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 |
|---|---|---|
| standard of care anticoagulation in absence of thrombotic complicationsSubgroup IA - patients receive UFH (heparin, 7500 Units 2-3 times daily) for the prevention or treatment of VTE Subgroup IB - patients receive LMWH (enoxaparin) for the prevention or treatment of VTE Subgroup IC - patients receive oral anticoagulants (rivaroxaban 10mg QD) for the prevention or treatment of VTE | Other | patients with COVID-19 without thrombotic complications |
| standard of care anticoagulation in presence of thrombotic complicationsSubgroup IIA - patients receive UFH (heparin, 7500 Units 2-3 times daily) for the prevention or treatment of VTE Subgroup IIB - patients receive LMWH (enoxaparin, 0.4ml 2 times daily) for the prevention or treatment of VTE Subgroup IIC - patients receive oral anticoagulants (rivaroxaban 10mg QD) for the prevention or treatment of VTE | Other | patients with COVID-19 and VTE who received pharmacological prophylaxis of VTE |
| standard of care anticoagulation in combination with elastic compressionSubgroup IIIA - patients receive UFH (heparin, 7500 Units 2-3 times daily) in combination with class II elastic compression (compression stockings above the level of the knee) for the prevention or treatment of VTE Subgroup IIIB - patients receive LMWH (enoxaparin, 0.4ml 2 times daily) in combination with class II elastic compression (compression stockings above the level of the knee) for the prevention or treatment of VTE Subgroup IIIC - patients receive oral anticoagulants (rivaroxaban 10mg QD) in combination with class II elastic compression (compression stockings above the level of the knee) for the prevention or treatment of VTE | Other | patients with COVID-19 and VTE who received pharmacomechanical prophylaxis of VTE |
Primary outcome
mortality
Time frame: one year
lethal outcomes
venous thrombosis or pulmonary embolism
Time frame: one year
a VTE event
arterial thrombosis
Time frame: one year
thrombosis of main arteries of the extremities or myocardial infarction or stroke
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Igor Suchkov, MD, PhD study chair
Ryazan State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Venous Thromboembolism and covid19, run by Ryazan State Medical University at 1 site in Russia.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2023.