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

Study Overview

• Status: Recruiting
• Conditions: COVID 19 Associated Coagulopathy
• Intervention / Treatment: Drug: Troxerutin; Drug: Placebo; Drug: troxerutin + low molecular weight heparin; Drug: placebo + low molecular weight heparin

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Xu Li, PhD; Phone Number: 13811635032; Email: lixu@westlake.edu.cn

Study Locations

• China
  • Zhejiang
    • Shaoxing, Zhejiang, China
      • Recruiting
      • Shaoxing Central Hospital
      • Contact: Xu Li, Doctor; Phone Number: 13811635032; Email: lixu@westlake.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Oral placebo tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily
Experimental: Troxerutin+low molecular weight heparin	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
Placebo Comparator: Placebo+low molecular weight heparin	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
Experimental: Troxerutin	Drug: Troxerutin; Oral troxerutin tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability of anticoagulation therapy	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.	Through 28 days
Adverse event	Percentage of patients experiencing at least one adverse event above grade 2	Through 28 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: April 6, 2024
• First Submitted That Met QC Criteria: April 6, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Estimated): November 12, 2024
• Last Update Submitted That Met QC Criteria: November 10, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Fibrinolytic Agents; Anticoagulants; Tinzaparin; Heparin; Heparin, Low-Molecular-Weight; Dalteparin; Calcium heparin; Troxerutin
• Other Study ID Numbers: 20230817LX001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No