Clinical trial NCT06355258: A Study of the Efficacy of Troxerutin in Preventing Thrombotic Events in COVID-19 Patients
Official title: A Study of the Efficacy of Troxerutin in Preventing Thrombotic Events in COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: COVID 19 Associated Coagulopathy
Lead sponsor: Westlake University
Sponsor class: OTHER
Collaborators: name: Shaoxing Central Hospital
name: Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
First posted: 2024-04-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: PREVENTION

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


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.

Primary outcomes:
measure: Overall number of patients in prothrombotic state through 7 days
timeFrame: Through 7 days
Secondary outcomes:
measure: Tolerability of anticoagulation therapy
timeFrame: Through 28 days
measure: Adverse event
timeFrame: Through 28 days
Other outcomes:
Locations:
city: Shaoxing
country: China
facility: Shaoxing central hospital
state: Zhejiang
Study officials:
References: