Clinical trial NCT04954222: Recovery of Respiratory System in COVID-19 Patients
Official title: Tracking the Recovery of Respiratory Physiology in COVID-19 Patients a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female participants that have tested positive for COVID-19 within 28 or more days will be recruited for this study. Individuals with or without continuing symptoms of COVID-19 can participate.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in diffusion capacity of the lungs
timeFrame: through study completion, an average of 5 months
measure: Change in airway morphology
timeFrame: through study completion, an average of 5 months
measure: change basic spirometry
timeFrame: through study completion, an average of 5 months
measure: Change in peak aerobic capacity
timeFrame: through study completion, an average of 5 months
measure: Presence of post-exertional malaise
timeFrame: through study completion, an average of 5 months
measure: Change in symptoms
timeFrame: through study completion, an average of 5 months
measure: change in quality of life
timeFrame: through study completion, an average of 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Bruce D Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References: