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Идёт набор NCT06006884

A Study of Post COVID-19 Mechanisms for Chronic Lung Sequelae

— Наблюдательное COVID-19

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: Bronchoscopies and Bronchoalveolar Lavages (BALs), Chest Tomography (CT), Electrocardiogram (ECG), Pulmonary function tests (PFTs).
Кому может быть актуально
Состояния в реестре: COVID-19. 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Uncover Mechanisms Underlying the Development of Chronic Lung Sequelae Post COVID-19

Обзор

The purpose of this study is to understand why some people experience long term effects, such as shortness of breath and fatigue, after a severe COVID-19 infection

Подробное описание

Each participant will be in the study for approximately 12 months and will be required to come to Mayo Clinic for 3 visits. These visits will take place approximately 2-3 months after confirmed COVID-19 diagnosis (visit 1), 6 months after diagnosis (visit 2), and 12 months after diagnosis (visit 3).

Comprehensive clinical evaluation and symptom characterization, quantitative lung CT image analysis and pulmonary function testing, and quality of life questionnaires will be obtained at each visit. Bronchoscopy with BAL (collected at visits 1 and 3 only) and blood samples (collected at all visits) will dissect the dynamic immunological and molecular signatures in the respiratory tract and in the circulation longitudinally. We will also perform highly sensitive viral reservoir or remnant assays to address the potential contribution of viral factors in regulating chronic lung conditions post-acute COVID-19.

Вмешательства

  • Процедура Bronchoscopies and Bronchoalveolar Lavages (BALs)
    Bronchoscopies use a thin, lighted tube, which enters through the mouth or nose and moves down the throat to the airways to look at the lungs. BALs are done during bronchoscopies to collect samples from the lungs for testing. During this procedure, a saline solution is put through the tube to wash the airways and collect a fluid sample.
  • Диагностический тест Chest Tomography (CT)
    X-ray to create images of the bones and internal organs of the body
  • Диагностический тест Electrocardiogram (ECG)
    Measures the electrical activity of the heart by using sticky pads that are placed on your chest and limbs.
  • Диагностический тест Pulmonary function tests (PFTs)
    Testing to measure how well lungs are working
  • Диагностический тест 6 minute walk test (6MWT)
    Walking test to see how well the lungs function with exercise over 6 minutes

Первичные конечные точки

  • Decipher clinical, imaging, immune, molecular and/or viral traits underlying post-acute COVID-19 lung sequelae [Срок оценки: 4 years]

Критерии участия

Критерии включения

For the Sequelae Group

  • Age ≥18 years at screening, PCR confirmed COVID19 illness (+PCR defines day 0 of illness), hospitalization for COVID-19, absence of pre-existing history of interstitial lung disease, or significant other lung disease.
  • Severity of illness will be categorized as moderate disease (supplemental oxygen need 1-8L at any time during hospitalization), severe disease (need for high flow oxygen delivery ≥8L at any time during hospitalization) and critical illness (need for ICU admission or mechanical ventilation).

Control Recovery Group

  • Age ≥18 years at screening
  • PCR confirmed COVID-19 cases who had nonsymptomatic or mild acute infection that do not require hospitalization 7,48,49
  • Absence of pre-existing history of interstitial lung disease, or significant other lung disease, absence of any ongoing respiratory and systemic symptoms.

Критерии исключения

  • Inability to provide informed consent, evidence of pre-existing interstitial lung disease or chronic lung disease;
  • Active cigarette smoking, vaping or other inhalation use.
  • Immunocompromised host status due to ongoing therapy with methotrexate, CellCept, azathioprine, rituximab, cyclophosphamide or other biologic agents;
  • > 20 pack year smoking history.
  • History of chemotherapy or radiation therapy in the last two years; and pregnancy.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Mayo Clinic Minnesota — Rochester

Идентификаторы

NCT: NCT06006884 · 23-001888

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗