NCT06355258 A Study of the Efficacy of Troxerutin in Preventing Thrombotic Events in COVID-19 Patients
| NCT ID | NCT06355258 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Westlake University |
| Condition | COVID 19 Associated Coagulopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-12-15 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2023-12-15 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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: * Does troxerutin lower the number of thrombotic events in participants? * 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. Participants will: * Take troxerutin or a placebo every day for 7 days. * Visit the clinic at the first, fourth, seventh and 28th days after enrollment for checkups and tests * Keep a diary of their symptoms and the number of times of thrombotic events, bleeding events and type II HIT-related thrombocytopenia
Eligibility Criteria
Inclusion Criteria: As long as the patient meets all of the following conditions, adult patients aged 18 and above are eligible for admission: ► COVID-19 patients, defined as: positive RT-PCR (upper respiratory tract or lower respiratory tract) for SARS-CoV-2. Mild COVID-19 patients are defined as: Symptomatic 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. Severe COVID-19 patients are defined as: Adolescents or adults with clinical signs of pneumonia (i.e., fever, cough, dyspnea, tachypnea) plus one of the following: 1. Respiratory rate ≥30 breaths/min 2. Severe respiratory distress 3. Oxygen saturation (SpO₂) ≤90% in room air 4. Progressive deterioration of clinical symptoms with lung imaging showing significant progression of lesions (\>50%) within 24 to 48 hours. * Written informed consent provided according to Chinese law (by the patient, legal guardian, or deferred consent in emergencies). Exclusion Criteria: Patients with any of the following conditions will be excluded from the study: * Pregnant or lactating women. * Postpartum (within 6 weeks). * Extreme weight (100 kilograms). * Clinical need for heparin therapy. * Bleeding related to coagulation disorders, acute clinically significant bleeding, active gastrointestinal ulcers, or any organic lesions with high bleeding risk. * Platelet count \<50 x 10\^9/L. * Surgery within the last 15 days, or within 24 hours after spinal or epidural anesthesia. * History of intracranial hemorrhage, large ischemic stroke, known intracranial malformation or tumor, acute infective endocarditis. * Severe renal impairment (creatinine clearance \<30 mL/min). * Iodine allergy. * Long-term use of oxygen supplementation. * Moribund patients or those expected to die during the current hospitalization due to underlying disease. * Patients deprived of freedom and those undergoing institutional psychiatric care. * Ward of the state or under guardianship. * Participation in other anticoagulant intervention studies.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06355258 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying COVID 19 Associated Coagulopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06355258 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06355258 currently recruiting?
Yes, NCT06355258 is actively recruiting participants. Contact the research team at lixu@westlake.edu.cn for enrollment information.
Where is the NCT06355258 trial being conducted?
This trial is being conducted at Shaoxing, China.
Who is sponsoring the NCT06355258 clinical trial?
NCT06355258 is sponsored by Westlake University. The trial plans to enroll 80 participants.
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