COVID 19 Associated Coagulopathy
Conditions
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
Interventions
DRUGTroxerutin
Oral troxerutin tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily
DRUGPlacebo
Oral placebo tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily
DRUGplacebo + 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
DRUGtroxerutin + 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
Sponsors
Shaoxing Central Hospital
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Westlake University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Adverse event | Through 28 days | Percentage of patients experiencing at least one adverse event above grade 2 |
Countries
China
Contacts
Primary ContactXu Li, PhD
Outcome results
None listed