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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

‣ 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:

• 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.

⁃ Written informed consent provided according to Chinese law (by the patient, legal guardian, or deferred consent in emergencies).

Locations
Other Locations
China
Shaoxing central hospital
RECRUITING
Shaoxing
Contact Information
Primary
Xu Li, PhD
lixu@westlake.edu.cn
13811635032
Time Frame
Start Date: 2023-12-15
Estimated Completion Date: 2025-03
Participants
Target number of participants: 80
Treatments
Experimental: Troxerutin+low molecular weight heparin
Placebo_comparator: Placebo+low molecular weight heparin
Experimental: Troxerutin
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Westlake University
Collaborators: Shaoxing Central Hospital, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University

This content was sourced from clinicaltrials.gov