Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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)
  • 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
Recovery group Age and gender matched individuals who had mild SARS-CoV-2 infection and experienced complete resolution of symptoms
  • 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

Recruiting Locations

Mayo Clinic Minnesota
Rochester, Minnesota 55905
Contact:
Chris Roberts
800-753-1606
roberts.chris@mayo.edu

More Details

NCT ID
NCT06006884
Status
Recruiting
Sponsor
Mayo Clinic

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.