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

NCT ID: NCT06355258

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-15
• Study Completion Date: 2025-03-31

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 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

Conditions

COVID 19 Associated Coagulopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Troxerutin+low molecular weight heparin

Group Type: EXPERIMENTAL

troxerutin + low molecular weight heparin

Intervention Type: DRUG

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

Placebo+low molecular weight heparin

Group Type: PLACEBO_COMPARATOR

placebo + low molecular weight heparin

Intervention Type: DRUG

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

Troxerutin

Group Type: EXPERIMENTAL

Troxerutin

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Troxerutin

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

Intervention Type: DRUG

Placebo

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shaoxing Central Hospital

OTHER

Sponsor Role: collaborator

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

UNKNOWN

Sponsor Role: collaborator

Westlake University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shaoxing central hospital

Shaoxing, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xu Li, PhD

Role: CONTACT

lixu@westlake.edu.cn

13811635032

Facility Contacts

Xu Li, Doctor

Role: primary

lixu@westlake.edu.cn

13811635032

Other Identifiers

20230817LX001

Identifier Type: -

Identifier Source: org_study_id