Status:
RECRUITING
A Study of the Efficacy of Troxerutin in Preventing Thrombotic Events in COVID-19 Patients
Lead Sponsor:
Westlake University
Collaborating Sponsors:
Shaoxing Central Hospital
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Conditions:
COVID 19 Associated Coagulopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
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:
-
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.
Key Trial Info
Start Date :
December 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06355258
Start Date
December 15 2023
End Date
March 1 2025
Last Update
November 12 2024
Active Locations (1)
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1
Shaoxing central hospital
Shaoxing, Zhejiang, China