Health TrialsbyHealthPanel

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

ConditionCOVID 19 Associated Coagulopathy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWestlake University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Pregnant or lactating women.

Postpartum (within 6 weeks).

Extreme weight (100 kilograms).

Clinical need for heparin therapy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Troxerutin

    Drug

    Oral troxerutin tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily

  • 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

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: Troxerutin+low molecular weight heparinExperimental treatment 1 intervention
Group B: Placebo+low molecular weight heparinPlacebo comparator 1 intervention
Group C: TroxerutinExperimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Through 7 days

Secondary outcomes

1

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.

Time frame
Through 28 days
2

Adverse event

Percentage of patients experiencing at least one adverse event above grade 2

Time frame
Through 28 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Westlake University

Lead sponsor

Shaoxing Central Hospital

Collaborator

Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University

Collaborator

Source ClinicalTrials.gov
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