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

Last updated: November 10, 2024
Sponsor: Westlake University
Overall Status: Active - Recruiting

Phase

1

Condition

Covid-19

Treatment

placebo + low molecular weight heparin

Troxerutin

Placebo

Clinical Study ID

NCT06355258
20230817LX001
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 significantprogression 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

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 epiduralanesthesia.

  • History of intracranial hemorrhage, large ischemic stroke, known intracranialmalformation 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 tounderlying disease.

  • Patients deprived of freedom and those undergoing institutional psychiatric care.

  • Ward of the state or under guardianship.

  • Participation in other anticoagulant intervention studies.

Study Design

Total Participants: 80
Treatment Group(s): 4
Primary Treatment: placebo + low molecular weight heparin
Phase: 1
Study Start date:
December 15, 2023
Estimated Completion Date:
March 31, 2025

Connect with a study center

  • Shaoxing central hospital

    Shaoxing, Zhejiang
    China

    Active - Recruiting

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