Actively Recruiting
A Study of the Efficacy of Troxerutin in Preventing Thrombotic Events in COVID-19 Patients
Led by Westlake University · Updated on 2024-11-12
80
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
W
Westlake University
Lead Sponsor
S
Shaoxing Central Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether troxerutin can help prevent blood clots in adults with mild or severe COVID-19. This Phase 1 clinical trial aims to compare troxerutin with a placebo to see if it reduces thrombotic events and to assess the safety of troxerutin in this patient group. The study addresses key questions about how often blood clots occur and what side effects may happen during treatment. Participants will receive either oral troxerutin tablets or matching placebo tablets twice daily for 7 days. Some groups will also receive low molecular weight heparin once daily. The study includes four visits to the clinic on days 1, 4, 7, and 28 for checkups and tests. Participants will keep a diary tracking symptoms, blood clot events, bleeding events, and a specific blood platelet condition related to heparin. During the study, researchers will monitor participants' health through clinical assessments and laboratory tests to measure the number of patients in a prothrombotic state over 7 days. Safety will be evaluated by recording any adverse events through 28 days. The total involvement includes treatment and follow-up visits over about four weeks, ensuring close observation of participants' responses and any side effects.
CONDITIONS
Brief Title
A Study of the Efficacy of Troxerutin in Preventing Thrombotic Events in COVID-19 Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years and older
- Confirmed COVID-19 infection by positive RT-PCR test
- Mild COVID-19: symptomatic without hypoxia or pneumonia
- Severe COVID-19: signs of pneumonia plus one of respiratory rate ≥30 breaths/min, severe respiratory distress, oxygen saturation ≤90%, or worsening lung lesions within 24-48 hours
- Written informed consent provided according to Chinese law
You will not qualify if you...
- Pregnant or lactating women
- Postpartum within 6 weeks
- Extreme weight over 100 kilograms
- Need for heparin therapy
- Bleeding disorders or active significant bleeding
- Platelet count less than 50 x 10^9/L
- Recent surgery within 15 days or spinal/epidural anesthesia within 24 hours
- History of intracranial hemorrhage, large ischemic stroke, intracranial malformation or tumor, or acute infective endocarditis
- Severe kidney impairment with creatinine clearance below 30 mL/min
- Iodine allergy
- Long-term oxygen use
- Patients expected to die during hospitalization
- Patients under institutional psychiatric care or deprived of freedom
- Under guardianship or ward of the state
- Participation in other anticoagulant intervention studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants take oral tablets of troxerutin or placebo, with or without low molecular weight heparin, twice daily to prevent thrombotic events.
Daily visits or assessments during treatment period
Duration - 21 days
Participants are monitored for tolerability of anticoagulation therapy and adverse events after treatment ends.
Periodic visits or assessments up to 28 days total
Trial Site Locations
Total: 1 location
1
Shaoxing central hospital
Shaoxing, Zhejiang, China
Actively Recruiting
Research Team
X
Xu Li, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
Frequently Asked Questions
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