Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2026-04-12 @ 11:58 AM
Study NCT ID:
NCT06355258
Status:
RECRUITING
Last Update Posted:
2024-11-12
First Post:
2024-04-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Efficacy of Troxerutin in Preventing Thrombotic Events in COVID-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-07-14', 'releaseDate': '2025-06-26'}], 'estimatedResultsFirstSubmitDate': '2025-06-26'}}, 'interventionBrowseModule': {'meshes': [{'id': 'C005865', 'term': 'troxerutin'}, {'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}], 'ancestors': [{'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'According to the inclusion criteria, participants will be randomly divided into mild patients and severe patients, and then patients with severe disease were randomly assigned to placebo + low molecular weight heparin group or troxerutin + low molecular weight heparin group, and patients with mild disease were randomly assigned to placebo group or troxerutin group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-10', 'studyFirstSubmitDate': '2024-04-06', 'studyFirstSubmitQcDate': '2024-04-06', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall number of patients in prothrombotic state through 7 days', 'timeFrame': 'Through 7 days', 'description': "Assess coagulation-related parameters in patients' blood, including platelet count, prothrombin time (PT), antithrombin III activity (ATIIIa), plasma fibrinogen concentration (Fbg), and quantitative D-dimer.Patients with one or more indicators in the abnormal range, including PT \\< 11s (reference interval: 11-14 s), FG \\> 4g/L (reference interval: 2-4 g/L), D-dimer \\< 0.5 μg/mL (reference interval: 0-0.5 μg/mL), are considered in a prothrombotic state."}], 'secondaryOutcomes': [{'measure': 'Tolerability of anticoagulation therapy', 'timeFrame': 'Through 28 days', 'description': 'Percentage of patients experiencing at least one major bleeding event (MBE) as defined by the International Society on Thrombosis and Haemostasis (ISTH) by day 28.'}, {'measure': 'Adverse event', 'timeFrame': 'Through 28 days', 'description': 'Percentage of patients experiencing at least one adverse event above grade 2'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID 19 Associated Coagulopathy']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if troxerutin works to prevent thrombotic events in mild or severe COVID-19 patients. It will also learn about the safety of troxerutin. The main questions it aims to answer are:\n\n* Does troxerutin lower the number of thrombotic events in participants?\n* What medical problems do participants have when taking troxerutin? Researchers will compare troxerutin to a placebo (a look-alike substance that contains no drug) to see if troxerutin works to prevent thrombotic events in COVID-19 patients.\n\nParticipants will:\n\n* Take troxerutin or a placebo every day for 7 days.\n* Visit the clinic at the first, fourth, seventh and 28th days after enrollment for checkups and tests\n* Keep a diary of their symptoms and the number of times of thrombotic events, bleeding events and type II HIT-related thrombocytopenia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAs long as the patient meets all of the following conditions, adult patients aged 18 and above are eligible for admission:\n\n► COVID-19 patients, defined as: positive RT-PCR (upper respiratory tract or lower respiratory tract) for SARS-CoV-2.\n\nMild COVID-19 patients are defined as:\n\nSymptomatic patients meeting the case definition for COVID-19 without evidence of hypoxia or pneumonia. Common symptoms include fever, cough, fatigue, anorexia, dyspnea, and myalgia. Other nonspecific symptoms include sore throat, nasal congestion, headache, diarrhea, nausea/vomiting, and loss of smell/taste.\n\nSevere COVID-19 patients are defined as:\n\nAdolescents or adults with clinical signs of pneumonia (i.e., fever, cough, dyspnea, tachypnea) plus one of the following:\n\n1. Respiratory rate ≥30 breaths/min\n2. Severe respiratory distress\n3. Oxygen saturation (SpO₂) ≤90% in room air\n4. Progressive deterioration of clinical symptoms with lung imaging showing significant progression of lesions (\\>50%) within 24 to 48 hours.\n\n * Written informed consent provided according to Chinese law (by the patient, legal guardian, or deferred consent in emergencies).\n\nExclusion Criteria:\n\nPatients with any of the following conditions will be excluded from the study:\n\n* Pregnant or lactating women.\n* Postpartum (within 6 weeks).\n* Extreme weight (100 kilograms).\n* Clinical need for heparin therapy.\n* Bleeding related to coagulation disorders, acute clinically significant bleeding, active gastrointestinal ulcers, or any organic lesions with high bleeding risk.\n* Platelet count \\<50 x 10\\^9/L.\n* Surgery within the last 15 days, or within 24 hours after spinal or epidural anesthesia.\n* History of intracranial hemorrhage, large ischemic stroke, known intracranial malformation or tumor, acute infective endocarditis.\n* Severe renal impairment (creatinine clearance \\<30 mL/min).\n* Iodine allergy.\n* Long-term use of oxygen supplementation.\n* Moribund patients or those expected to die during the current hospitalization due to underlying disease.\n* Patients deprived of freedom and those undergoing institutional psychiatric care.\n* Ward of the state or under guardianship.\n* Participation in other anticoagulant intervention studies.'}, 'identificationModule': {'nctId': 'NCT06355258', 'briefTitle': 'A Study of the Efficacy of Troxerutin in Preventing Thrombotic Events in COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'Westlake University'}, 'officialTitle': 'A Study of the Efficacy of Troxerutin in Preventing Thrombotic Events in COVID-19 Patients', 'orgStudyIdInfo': {'id': '20230817LX001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Troxerutin+low molecular weight heparin', 'interventionNames': ['Drug: troxerutin + low molecular weight heparin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo+low molecular weight heparin', 'interventionNames': ['Drug: placebo + low molecular weight heparin']}, {'type': 'EXPERIMENTAL', 'label': 'Troxerutin', 'interventionNames': ['Drug: Troxerutin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Troxerutin', 'type': 'DRUG', 'description': 'Oral troxerutin tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily', 'armGroupLabels': ['Troxerutin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral placebo tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily', 'armGroupLabels': ['Placebo']}, {'name': 'placebo + low molecular weight heparin', 'type': 'DRUG', 'description': '2000 IU LMWH once a day + Oral placebo tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily', 'armGroupLabels': ['Placebo+low molecular weight heparin']}, {'name': 'troxerutin + low molecular weight heparin', 'type': 'DRUG', 'description': '2000 IU LMWH once a day + Oral troxerutin tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily', 'armGroupLabels': ['Troxerutin+low molecular weight heparin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shaoxing', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xu Li, Doctor', 'role': 'CONTACT', 'email': 'lixu@westlake.edu.cn', 'phone': '13811635032'}], 'facility': 'Shaoxing central hospital', 'geoPoint': {'lat': 30.00237, 'lon': 120.57864}}], 'centralContacts': [{'name': 'Xu Li, PhD', 'role': 'CONTACT', 'email': 'lixu@westlake.edu.cn', 'phone': '13811635032'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Westlake University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shaoxing Central Hospital', 'class': 'OTHER'}, {'name': "Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-06-26', 'type': 'RELEASE'}, {'date': '2025-07-14', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Westlake University'}}}}