Recovery of Respiratory System in COVID-19 Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine the effects of the clinical course of treatment as well as long-term symptoms of COVID-19 on respiratory function, exercise capacity, and quality of life.

Detailed Description
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This study will be completed over 4 sessions at the Mayo Clinic at either the Scottsdale Arizona or Rochester Minnesota locations. You will be asked to complete a series of questionnaires, lung function tests, and exercise tests at two time points: ≥ 28 days post diagnosis and 4-6 months after the first laboratory visit. All visits will take approximately 2 hours. During visits 1 and 3 a series of questionnaires as well as breathing tests, and an exercise test will be completed on a stationary bike. You will also be asked to breathe a gas mixture out of a bag to obtain measures of gas movement and sensitivity. During visits 2 and 4 you will complete an exercise test on a stationary bike to measure changes from the previous exercise test and a chest scan.

Official Title
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Tracking the Recovery of Respiratory Physiology in COVID-19 Patients a Pilot Study

Conditions
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Covid19

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a documented positive qRT-PCR for SARS-CoV-2 confirming prior COVID-19 diagnosis At least 18 years of age. Female subjects must not be pregnant or trying to become pregnant during the duration of study participation. No known plans to move out of the state, or become unable to return to one of the Mayo Clinic sites for follow-up testing. Must be able to provide clear informed written consent. Exclusion Criteria: Individuals with pacemakers or other implantable devices that will make interpreting a CT scan challenging. Individuals with major limitations to exercise.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID19 long haulers<br>Individuals that have been diagnosed with COVID19 and continue to have lingering symptoms associated with COVID19 | |
| COVID19 no residual symptoms<br>Individuals that have been diagnosed with COVID19 and do not have lingering symptoms that are associated with COVID19 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in diffusion capacity of the lungs | change in diffusing capacity of the lungs for carbon monoxide and its components | through study completion, an average of 5 months | 
| Change in airway morphology | CT assessment of airway diameter and thickness | through study completion, an average of 5 months | 
| change basic spirometry | Measurement of basic lung function using forced vital capacity (FVC), slow vital capacity (SVC), forced expiratory volume at one second (FEV1), maximal inspiratory pressure (MIPS), maximal expiratory pressure (MEPS), exhaled nitric oxide (ExNO), forced oscillation technique (FOT), overnight pulse oximetry | through study completion, an average of 5 months | 
| Change in peak aerobic capacity | Change in examine post exertional malaise | through study completion, an average of 5 months | 
| Presence of post-exertional malaise | Evaluation of change in performance on maximal exercise test over two days to identify presence of post-exertional malaise | through study completion, an average of 5 months | 
| Change in symptoms | St. George's respiratory Questionnaire scoring of pulmonary symptoms. Scores range from 0 to 100, with higher scores indicating more limitations. | through study completion, an average of 5 months | 
| change in quality of life | SF-36 questionnaire assessment of physical and mental health. Two scores one for physical functioning and one for mental functioning. Scores range from 0-100 with a higher score indicating better health | through study completion, an average of 5 months |