Recovery of Respiratory System in COVID-19 Patients
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| COVID19 long haulers Individuals that have been diagnosed with COVID19 and continue to have lingering symptoms associated with COVID19 |
|
| COVID19 no residual symptoms Individuals that have been diagnosed with COVID19 and do not have lingering symptoms that are associated with COVID19 |
Outcome Measures
Primary Outcome Measures
- Change in diffusion capacity of the lungs [through study completion, an average of 5 months]
change in diffusing capacity of the lungs for carbon monoxide and its components
- Change in airway morphology [through study completion, an average of 5 months]
CT assessment of airway diameter and thickness
- change basic spirometry [through study completion, an average of 5 months]
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
- Change in peak aerobic capacity [through study completion, an average of 5 months]
Change in examine post exertional malaise
- Presence of post-exertional malaise [through study completion, an average of 5 months]
Evaluation of change in performance on maximal exercise test over two days to identify presence of post-exertional malaise
- Change in symptoms [through study completion, an average of 5 months]
St. George's respiratory Questionnaire scoring of pulmonary symptoms. Scores range from 0 to 100, with higher scores indicating more limitations.
- change in quality of life [through study completion, an average of 5 months]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Have a documented positive qRT-PCR for SARS-CoV-2 confirming prior COVID-19 diagnosis
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At least 18 years of age.
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Female subjects must not be pregnant or trying to become pregnant during the duration of study participation.
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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.
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Must be able to provide clear informed written consent.
Exclusion Criteria:
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Individuals with pacemakers or other implantable devices that will make interpreting a CT scan challenging.
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Individuals with major limitations to exercise.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Arizona | Scottsdale | Arizona | United States | 85259 |
| 2 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Bruce D Johnson, PhD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 21-001028