Shaoxing central hospital
Shaoxing, Zhejiang, China
Location status: Recruiting
NCT Number: NCT06355258
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Shaoxing, Zhejiang, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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:
Exclusion criteria
Patients with any of the following conditions will be excluded from the study:
Oral troxerutin tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily
Oral placebo tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily
2000 IU LMWH once a day + Oral placebo tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily
2000 IU LMWH once a day + Oral troxerutin tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily
Time frame: 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.
Time frame: 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.
Time frame: Through 28 days
Percentage of patients experiencing at least one adverse event above grade 2
Contact information is provided by the study sponsor or research team.
Westlake University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06992401
Behavior, Behavioral Symptoms
View Trial DetailsNCT04360824
COVID 19 Associated Coagulopathy
Iowa City, Iowa, United States
View Trial DetailsNCT05679414
COVID 19 Associated Coagulopathy
Cairo, Egypt
View Trial DetailsNCT05496816
COVID 19 Associated Coagulopathy, Cardiovascular Diseases
Zenica, Bosnia and Herzegovina
View Trial Details