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Идёт набор NCT06355258

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

Фаза I С лечением COVID 19 Associated Coagulopathy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Troxerutin, Placebo, placebo + low molecular weight heparin, troxerutin + low molecular weight heparin.
Кому может быть актуально
Состояния в реестре: COVID 19 Associated Coagulopathy. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Обзор

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

Вмешательства

  • Препарат Troxerutin
    Oral troxerutin tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily
  • Препарат Placebo
    Oral placebo tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily
  • Препарат placebo + low molecular weight heparin
    2000 IU LMWH once a day + Oral placebo tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily
  • Препарат troxerutin + low molecular weight heparin
    2000 IU LMWH once a day + Oral troxerutin tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily

Первичные конечные точки

  • Overall number of patients in prothrombotic state through 7 days [Срок оценки: Through 7 days]
Вторичные конечные точки (2)
  • Tolerability of anticoagulation therapy [Срок оценки: Through 28 days]
  • Adverse event [Срок оценки: Through 28 days]

Критерии участия

Критерии включения

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).

Критерии исключения

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.
  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Профилактика

Центры проведения

Китай · 1 центр
  • Shaoxing central hospital — Shaoxing

Идентификаторы

NCT: NCT06355258 · 20230817LX001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗