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

Phase 1

Recruiting

• Conditions: COVID 19 Associated Coagulopathy
• Interventions: Drug: troxerutin + low molecular weight heparin; Drug: placebo + low molecular weight heparin; Drug: Troxerutin; Drug: Placebo

• Registration Number: NCT06355258
• Lead Sponsor: Westlake University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-15
• Study First Submitted: 2024-04-06
• Study First Submitted QC: 2024-04-06
• Study First Posted: 2024-04-09
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-10
• Last Update Posted: 2024-11-12
• Primary Completion: 2024-12
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Troxerutin+low molecular weight heparin	troxerutin + low molecular weight heparin	-
Placebo+low molecular weight heparin	placebo + low molecular weight heparin	-
Troxerutin	Troxerutin	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Overall number of patients in prothrombotic state through 7 days	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.

Secondary Outcome Measures

Name	Time	Method
Adverse event	Through 28 days	Percentage of patients experiencing at least one adverse event above grade 2
Tolerability of anticoagulation therapy	Through 28 days	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.

Trial Locations

Locations (1)

Shaoxing central hospital; 🇨🇳 Shaoxing, Zhejiang, China