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| Name | Class |
|---|---|
| Shaoxing Central Hospital | OTHER |
| Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University | UNKNOWN |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Troxerutin+low molecular weight heparin | Experimental |
| |
| Placebo+low molecular weight heparin | Placebo Comparator |
| |
| Troxerutin | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Troxerutin | Drug | Oral troxerutin tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall number of patients in prothrombotic state 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. | Through 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through 28 days |
| Adverse event |
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Inclusion Criteria:
As long as the patient meets all of the following conditions, adult patients aged 18 and above are eligible for admission:
â–º 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:
Respiratory rate ≥30 breaths/min
Severe respiratory distress
Oxygen saturation (SpO₂) ≤90% in room air
Progressive deterioration of clinical symptoms with lung imaging showing significant progression of lesions (>50%) within 24 to 48 hours.
Exclusion Criteria:
Patients with any of the following conditions will be excluded from the study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xu Li, PhD | Contact | 13811635032 | lixu@westlake.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaoxing central hospital | Recruiting | Shaoxing | Zhejiang | China |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 26, 2025 | |
| Reset | Jul 14, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 26, 2025 | Jul 14, 2025 |
| ID | Term |
|---|---|
| C005865 | troxerutin |
| D006495 | Heparin, Low-Molecular-Weight |
| ID | Term |
|---|---|
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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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
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| Placebo | Drug | Oral placebo tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily |
|
| placebo + low molecular weight heparin | Drug | 2000 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 | Drug | 2000 IU LMWH once a day + Oral troxerutin tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily |
|
Percentage of patients experiencing at least one adverse event above grade 2
| Through 28 days |