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

COVID 19 Associated Coagulopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06355258
• Other study ID #: 20230817LX001
• Status: Recruiting
• Phase: Phase 1
• Start date: September 15, 2023
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Westlake University
• Contact: Xu Li, PhD
• Phone: 13811635032
• Email: lixu[@]westlake.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• COVID 19 Associated Coagulopathy
• COVID-19

Intervention

Drug:
• Troxerutin
Oral troxerutin tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily
• Placebo
Oral placebo tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily
• placebo + low molecular weight heparin
4000 IU LMWH once a day + Oral placebo tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily
• troxerutin + low molecular weight heparin
4000 IU LMWH once a day + Oral troxerutin tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily

Locations

Country	Name	City	State
China	Shaoxing central hospital	Shaoxing	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Westlake University	Shaoxing Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall number of thrombotic events through 28 days	The percentage of patients experiencing at least one thrombotic event by day 28, including ischemic stroke, non-cerebral arterial thrombotic events, deep vein thrombosis, pulmonary embolism, or deep vein thrombosis related to central venous catheters. Simultaneously, 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.	Through 28 days
Primary	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. Percentage of patients experiencing at least one life-threatening bleeding event as defined by the Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY) by day 28. Percentage of patients experiencing any bleeding event (whether major or minor), with minor bleeding events defined as all non-MBE bleedings, by day 28. Percentage of patients experiencing HIT by day 28.	Through 28 days
Secondary	Time to clinical improvement in patients through 28 days	assessing the time to clinical improvement at day 28. By calculation, death is considered a worse outcome than delayed clinical improvement. Time to clinical improvement (in days) is defined as the time from randomization to at least a two-point improvement (relative to the state at randomization) using the seven-point scale recommended by the World Health Organization (WHO).	Through 28 days