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Recruiting NCT06355258

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

Phase I Interventional COVID 19 Associated Coagulopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Troxerutin, Placebo, placebo + low molecular weight heparin, troxerutin + low molecular weight heparin.
Who it may be relevant to
Registry conditions: COVID 19 Associated Coagulopathy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Drug Troxerutin
    Oral troxerutin tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily
  • Drug Placebo
    Oral placebo tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily
  • Drug placebo + low molecular weight heparin
    2000 IU LMWH once a day + Oral placebo tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily
  • Drug troxerutin + low molecular weight heparin
    2000 IU LMWH once a day + Oral troxerutin tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily

Primary outcome measures

  • Overall number of patients in prothrombotic state through 7 days [Time frame: Through 7 days]
Secondary outcome measures (2)
  • Tolerability of anticoagulation therapy [Time frame: Through 28 days]
  • Adverse event [Time frame: Through 28 days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

China · 1 center
  • Shaoxing central hospital — Shaoxing

Identifiers

NCT: NCT06355258 · 20230817LX001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗