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
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.
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
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.
Mayo Clinic Minnesota
Rochester, Minnesota, United States
Investigator: Chris Roberts
Contact: 800-753-1606
roberts.chris@mayo.edu
Robert Vassallo, MD, Principal Investigator
Mayo Clinic