Uncover Mechanisms Underlying the Development of Chronic Lung Sequelae Post COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Decipher clinical, imaging, immune, molecular and/or viral traits underlying post-acute COVID-19 lung sequelae
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Sequelae group
COVID-19 convalescents that recover from prior severe acute diseases requiring hospitalization and who will be at high risk of chronic lung sequelae (with an estimate of >50% having moderate to severe sequelae based on current literature)
干预措施: Bronchoscopies and Bronchoalveolar Lavages (BALs) (Procedure)
Sequelae group
COVID-19 convalescents that recover from prior severe acute diseases requiring hospitalization and who will be at high risk of chronic lung sequelae (with an estimate of >50% having moderate to severe sequelae based on current literature)
干预措施: Chest Tomography (CT) (Diagnostic Test)
Sequelae group
COVID-19 convalescents that recover from prior severe acute diseases requiring hospitalization and who will be at high risk of chronic lung sequelae (with an estimate of >50% having moderate to severe sequelae based on current literature)
干预措施: Electrocardiogram (ECG) (Diagnostic Test)
Sequelae group
COVID-19 convalescents that recover from prior severe acute diseases requiring hospitalization and who will be at high risk of chronic lung sequelae (with an estimate of >50% having moderate to severe sequelae based on current literature)
干预措施: Pulmonary function tests (PFTs) (Diagnostic Test)
Sequelae group
COVID-19 convalescents that recover from prior severe acute diseases requiring hospitalization and who will be at high risk of chronic lung sequelae (with an estimate of >50% having moderate to severe sequelae based on current literature)
干预措施: 6 minute walk test (6MWT) (Diagnostic Test)
Recovery group
Age and gender matched individuals who had mild SARS-CoV-2 infection and experienced complete resolution of symptoms
干预措施: Bronchoscopies and Bronchoalveolar Lavages (BALs) (Procedure)
Recovery group
Age and gender matched individuals who had mild SARS-CoV-2 infection and experienced complete resolution of symptoms
干预措施: Chest Tomography (CT) (Diagnostic Test)
Recovery group
Age and gender matched individuals who had mild SARS-CoV-2 infection and experienced complete resolution of symptoms
干预措施: Electrocardiogram (ECG) (Diagnostic Test)
Recovery group
Age and gender matched individuals who had mild SARS-CoV-2 infection and experienced complete resolution of symptoms
干预措施: Pulmonary function tests (PFTs) (Diagnostic Test)
Recovery group
Age and gender matched individuals who had mild SARS-CoV-2 infection and experienced complete resolution of symptoms
干预措施: 6 minute walk test (6MWT) (Diagnostic Test)
结局指标
主要结局
Decipher clinical, imaging, immune, molecular and/or viral traits underlying post-acute COVID-19 lung sequelae
时间窗: 4 years
This study will expand on prior observations from a previous study and discover potential drivers and targets for therapy of post-acute COVID-19 lung disease by recruiting a larger group of COVID-19 convalescents, following up longitudinally up to 12 months after acute infection. This longitudinal approach will allow for assess immune dysregulation and establish the etiology of lung sequelae of COVID-19
次要结局
未报告次要终点
研究者
Robert Vassallo
Principal Investigator
Mayo Clinic