RecruitingNCT06006884

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

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

Sponsor

Mayo Clinic

Enrollment

75 participants

Start Date

Jan 10, 2024

Study Type

OBSERVATIONAL

Conditions

COVID-19

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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 Criteria5

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.

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Interventions

PROCEDUREBronchoscopies 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_TESTChest Tomography (CT)

X-ray to create images of the bones and internal organs of the body

DIAGNOSTIC_TESTElectrocardiogram (ECG)

Measures the electrical activity of the heart by using sticky pads that are placed on your chest and limbs.

DIAGNOSTIC_TESTPulmonary function tests (PFTs)

Testing to measure how well lungs are working

DIAGNOSTIC_TEST6 minute walk test (6MWT)

Walking test to see how well the lungs function with exercise over 6 minutes