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:

  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.

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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Shaoxing central hospital

Shaoxing, Zhejiang, China