A Study of Post COVID-19 Mechanisms for Chronic Lung Sequelae
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bronchoscopies and Bronchoalveolar Lavages (BALs), Chest Tomography (CT), Electrocardiogram (ECG), Pulmonary function tests (PFTs).
- Who it may be relevant to
- Registry conditions: COVID-19. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Uncover Mechanisms Underlying the Development of Chronic Lung Sequelae Post COVID-19
Overview
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
Detailed description
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.
Interventions
- Procedure 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. - Diagnostic test Chest Tomography (CT)
X-ray to create images of the bones and internal organs of the body - Diagnostic test Electrocardiogram (ECG)
Measures the electrical activity of the heart by using sticky pads that are placed on your chest and limbs. - Diagnostic test Pulmonary function tests (PFTs)
Testing to measure how well lungs are working - Diagnostic test 6 minute walk test (6MWT)
Walking test to see how well the lungs function with exercise over 6 minutes
Primary outcome measures
- Decipher clinical, imaging, immune, molecular and/or viral traits underlying post-acute COVID-19 lung sequelae [Time frame: 4 years]
Eligibility criteria
Inclusion criteria
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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mayo Clinic Minnesota — Rochester
Identifiers
NCT: NCT06006884 · 23-001888