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

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

Recruiting
18 years and older
All
Phase 1

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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

Eligibility

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.

Study details
    COVID 19 Associated Coagulopathy

NCT06355258

Westlake University

13 April 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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