Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06355258

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

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shaoxing central hospital

Shaoxing, Zhejiang, China

Location status: Recruiting

Location contact

Xu Li, Doctor

CONTACT

[email protected]

13811635032

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Troxerutin

Drug

Oral troxerutin tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily

Placebo

Drug

Oral placebo tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily

placebo + low molecular weight heparin

Drug

2000 IU LMWH once a day + Oral placebo tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily

troxerutin + low molecular weight heparin

Drug

2000 IU LMWH once a day + Oral troxerutin tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily

Primary outcomes

  1. Overall number of patients in prothrombotic state through 7 days

    Time frame: Through 7 days

    Assess coagulation-related parameters in patients' blood, including platelet count, prothrombin time (PT), antithrombin III activity (ATIIIa), plasma fibrinogen concentration (Fbg), and quantitative D-dimer.Patients with one or more indicators in the abnormal range, including PT < 11s (reference interval: 11-14 s), FG > 4g/L (reference interval: 2-4 g/L), D-dimer < 0.5 μg/mL (reference interval: 0-0.5 μg/mL), are considered in a prothrombotic state.

Secondary outcomes

  1. Tolerability of anticoagulation therapy

    Time frame: Through 28 days

    Percentage of patients experiencing at least one major bleeding event (MBE) as defined by the International Society on Thrombosis and Haemostasis (ISTH) by day 28.

  2. Adverse event

    Time frame: Through 28 days

    Percentage of patients experiencing at least one adverse event above grade 2

Study contacts

Contact information is provided by the study sponsor or research team.

Xu Li, PhD

CONTACT

[email protected]

13811635032

Sponsors and collaborators

Lead sponsor

Westlake University

Other

Collaborators

  • Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
  • Shaoxing Central Hospital

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Apr 9, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.