Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-27 @ 4:27 AM
Study NCT ID:
NCT05143567
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2021-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemostasis and Inflammation in COVID-19 Patients With Venous and Arterial Thrombotic Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open-label cohort longitudinal study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-07-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-15', 'studyFirstSubmitDate': '2021-11-20', 'studyFirstSubmitQcDate': '2021-11-20', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality', 'timeFrame': 'one year', 'description': 'lethal outcomes'}, {'measure': 'venous thrombosis or pulmonary embolism', 'timeFrame': 'one year', 'description': 'a VTE event'}, {'measure': 'arterial thrombosis', 'timeFrame': 'one year', 'description': 'thrombosis of main arteries of the extremities or myocardial infarction or stroke'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['venous thromboembolism', 'VTE', 'thrombotic events', 'coronavirus', 'COVID-19', 'hemostasis', 'platelet function'], 'conditions': ['Venous Thromboembolism', 'covid19', 'Thrombosis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men or women over 18 years of age with a new coronavirus infection, confirmed by polymerase chain reaction (PCR) studies and chest CT.\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT05143567', 'briefTitle': 'Hemostasis and Inflammation in COVID-19 Patients With Venous and Arterial Thrombotic Complications', 'organization': {'class': 'OTHER', 'fullName': 'Ryazan State Medical University'}, 'officialTitle': 'Comprehensive Assessment of the Hemostasis and Inflammation in Patients With Venous and Arterial Thrombotic Complications in Treatment of New Coronaviral Infection (COVID-19)', 'orgStudyIdInfo': {'id': '11.10.2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients with COVID-19 without thrombotic complications', 'description': 'Group I: 50 patients with confirmed coronavirus infection without thrombotic complications', 'interventionNames': ['Other: standard of care anticoagulation in absence of thrombotic complications']}, {'type': 'EXPERIMENTAL', 'label': 'patients with COVID-19 and VTE who received pharmacological prophylaxis of VTE', 'description': 'Group II: 50 patients with confirmed coronavirus infection with thrombotic complications confirmed by ultrasonography with pharmacological prophylaxis of VTE', 'interventionNames': ['Other: standard of care anticoagulation in presence of thrombotic complications']}, {'type': 'EXPERIMENTAL', 'label': 'patients with COVID-19 and VTE who received pharmacomechanical prophylaxis of VTE', 'description': '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.', 'interventionNames': ['Other: standard of care anticoagulation in combination with elastic compression']}], 'interventions': [{'name': 'standard of care anticoagulation in absence of thrombotic complications', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['patients with COVID-19 without thrombotic complications']}, {'name': 'standard of care anticoagulation in presence of thrombotic complications', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['patients with COVID-19 and VTE who received pharmacological prophylaxis of VTE']}, {'name': 'standard of care anticoagulation in combination with elastic compression', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['patients with COVID-19 and VTE who received pharmacomechanical prophylaxis of VTE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '390026', 'city': 'Ryazan', 'country': 'Russia', 'facility': 'Ryazan State Medical University', 'geoPoint': {'lat': 54.62696, 'lon': 39.70415}}], 'overallOfficials': [{'name': 'Igor Suchkov, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ryazan State Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ryazan State Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Post-doctoral researcher', 'investigatorFullName': 'Agapov Andrey Borisovich', 'investigatorAffiliation': 'Ryazan State Medical University'}}}}