NCT06355258RecruitingPhase 1
A Study of the Efficacy of Troxerutin in Preventing Thrombotic Events in COVID-19 Patients
Westlake University1 site in 1 country80 target enrollmentStarted: December 15, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Overall number of patients in prothrombotic state through 7 days
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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-
- •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:
- •Respiratory rate ≥30 breaths/min
- •Severe respiratory distress
- •Oxygen saturation (SpO₂) ≤90% in room air
- •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.
Arms & Interventions
Troxerutin+low molecular weight heparin
Experimental
Intervention: troxerutin + low molecular weight heparin (Drug)
Placebo+low molecular weight heparin
Placebo Comparator
Intervention: placebo + low molecular weight heparin (Drug)
Troxerutin
Experimental
Intervention: Troxerutin (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Overall number of patients in prothrombotic state through 7 days
Time Frame: Through 7 days
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.
Secondary Outcomes
- Tolerability of anticoagulation therapy(Through 28 days)
- Adverse event(Through 28 days)
Investigators
Study Sites (1)
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