Tracking the Recovery of Respiratory Physiology in COVID-19 Patients a Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- change in quality of life
Study Overview
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.
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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
change in quality of life
Time Frame: 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
Change in diffusion capacity of the lungs
Time Frame: through study completion, an average of 5 months
change in diffusing capacity of the lungs for carbon monoxide and its components
Presence of post-exertional malaise
Time Frame: 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 basic spirometry
Time Frame: 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 symptoms
Time Frame: 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 airway morphology
Time Frame: through study completion, an average of 5 months
CT assessment of airway diameter and thickness
Change in peak aerobic capacity
Time Frame: through study completion, an average of 5 months
Change in examine post exertional malaise
Secondary Outcomes
No secondary outcomes reported
Investigators
Courtney M. Wheatley
Co-Principal Investigator
Mayo Clinic