Using troxerutin to prevent blood clots in COVID-19 patients

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

This study is testing if troxerutin can help prevent blood clots in people with COVID-19, whether their symptoms are mild or severe.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Westlake University (Academic / other)
• Locations: 1 site (Shaoxing, Zhejiang)
• Trial ID: NCT06355258 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy of troxerutin in preventing thrombotic events in patients diagnosed with COVID-19, both mild and severe. Participants will be randomly assigned to receive either troxerutin or a placebo daily for seven days, with follow-up visits on specific days for health assessments. The study will monitor the occurrence of thrombotic events, bleeding events, and any adverse effects associated with troxerutin. The goal is to determine if troxerutin can effectively reduce the risk of blood clots in these patients.

Who should consider this trial

Good fit: Ideal candidates for this study are adult patients aged 18 and above who have tested positive for COVID-19, either with mild symptoms or severe pneumonia.

Not a fit: Patients who do not have a confirmed COVID-19 diagnosis or those with contraindications to troxerutin may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence of thrombotic events in COVID-19 patients, improving their overall health outcomes.

How similar studies have performed: While there have been studies exploring treatments for COVID-19-related coagulopathy, the specific use of troxerutin for this purpose is novel and has not been extensively tested.

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.

Where this trial is running

Shaoxing, Zhejiang

• Shaoxing central hospital — Shaoxing, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Xu Li, PhD

Conditions COVID 19 Associated Coagulopathy