A Study of the Efficacy of Troxerutin in Preventing Thrombotic Events in COVID-19 Patients

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: COVID 19 Associated Coagulopathy

In brief

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

Key facts

Study ID

NCT06355258

Run by

Westlake University

People needed

80

Starts

2023-12-15

Expected to finish

2025-03-01

Last updated by the study team

2024-11-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Shaoxing central hospital — Shaoxing, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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