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

NCT06355258 | Recruiting Phase 1

• 1 other identifier: 20230817LX001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Overall number of patients in prothrombotic state 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.

  Through 7 days

Secondary Outcomes (2)

• Tolerability of anticoagulation therapy

  Through 28 days

• Adverse event

  Through 28 days

Study Arms (4)

Troxerutin+low molecular weight heparin

EXPERIMENTAL

Drug: troxerutin + low molecular weight heparin

Placebo+low molecular weight heparin

PLACEBO COMPARATOR

Drug: placebo + low molecular weight heparin

Troxerutin

EXPERIMENTAL

Drug: Troxerutin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Troxerutin DRUG

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

Troxerutin

Placebo DRUG

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

Placebo

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

Placebo+low molecular weight heparin

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

Troxerutin+low molecular weight heparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Shaoxing central hospital

Shaoxing, Zhejiang, China

RECRUITING

MeSH Terms

Interventions

troxerutin; Heparin, Low-Molecular-Weight

Intervention Hierarchy (Ancestors)

Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

Xu Li, PhD

CONTACT

13811635032; lixu@westlake.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: According to the inclusion criteria, participants will be randomly divided into mild patients and severe patients, and then patients with severe disease were randomly assigned to placebo + low molecular weight heparin group or troxerutin + low molecular weight heparin group, and patients with mild disease were randomly assigned to placebo group or troxerutin group

Study Record Dates

• First Submitted: April 6, 2024
• First Posted: April 9, 2024
• Study Start: December 15, 2023
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

CN (1)