COVID 19 Associated CoagulopathyPhase 1NCT06355258
A Study of the Efficacy of Troxerutin in Preventing Thrombotic Events in COVID-19 Patients
A Phase 1 study testing Troxerutin and troxerutin + low molecular weight heparin in people with COVID 19 Associated Coagulopathy, run by Westlake University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID 19 Associated Coagulopathy
- What is being tested?
- Troxerutin and troxerutin + low molecular weight heparin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2023to Mar 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shaoxing central hospital
Shaoxing, Zhejiang
Xu Li, Doctor, 13811635032, lixu@westlake.edu.cn
About this study
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.
Read more
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
- Conditions
- COVID 19 Associated Coagulopathy
- Being tested
- Troxerutin, Placebo, placebo + low molecular weight heparin, troxerutin + low molecular weight heparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TroxerutinDrug
Oral troxerutin tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily
PlaceboDrug
Oral placebo tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily
placebo + low molecular weight heparinDrug
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 heparinDrug
2000 IU LMWH once a day + Oral troxerutin tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily
| Study group | Role | What they receive |
|---|---|---|
| Troxerutin+low molecular weight heparin | Experimental | Not described Receives: Drug: troxerutin + low molecular weight heparin |
| Placebo+low molecular weight heparin | Placebo comparator | Not described Receives: Drug: placebo + low molecular weight heparin |
| Troxerutin | Experimental | Not described Receives: Drug: Troxerutin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through 7 days
Secondary outcomes (2)
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.
Measured: Through 28 days
Adverse event
Percentage of patients experiencing at least one adverse event above grade 2
Measured: Through 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start15 Dec 2023
- Primary completionDec 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID 19 Associated CoagulopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Westlake University
- Sponsor type
- University, hospital or other
- Collaborators
- Shaoxing Central Hospital, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355258
- Sponsor's protocol ID
- 20230817LX001
- Status last verified
- Nov 2024
- First submitted
- 6 Apr 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Efficacy of Troxerutin in Preventing Thrombotic Events in COVID-19 Patients
- ClinicalTrials.gov ID
- NCT06355258
- Acronym / sponsor ID
- 20230817LX001
- Conditions
- COVID 19 Associated Coagulopathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Westlake UniversityUniversity, hospital or other
- Collaborators
- Shaoxing Central Hospital, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Troxerutin+low molecular weight heparin | Experimental | Drug: troxerutin + low molecular weight heparin |
| Placebo+low molecular weight heparin | Placebo comparator | Drug: placebo + low molecular weight heparin |
| Troxerutin | Experimental | Drug: Troxerutin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- 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.
- Adolescents or adults with clinical signs of pneumonia (i.e., fever, cough, dyspnea, tachypnea) plus one of the following:
- Respiratory rate ≥30 breaths/min
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TroxerutinOral troxerutin tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily | Drug | Troxerutin |
| PlaceboOral placebo tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily | Drug | Placebo |
| placebo + low molecular weight heparin2000 IU LMWH once a day + Oral placebo tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily | Drug | Placebo+low molecular weight heparin |
| troxerutin + low molecular weight heparin2000 IU LMWH once a day + Oral troxerutin tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily | Drug | Troxerutin+low molecular weight heparin |
Primary outcome
Overall number of patients in prothrombotic state through 7 days
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.
2 secondary outcomes
Tolerability of anticoagulation therapy
Time frame: Through 28 days
Adverse event
Time frame: Through 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Post-Acute Sequelae of SARS-CoV-2 Infection, Long COVID
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Troxerutin and troxerutin + low molecular weight heparin in people with COVID 19 Associated Coagulopathy, run by Westlake University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xu Li, PhD (13811635032, lixu@westlake.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall number of patients in prothrombotic state through 7 days (time frame: Through 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.