Covid19NCT04954222
Recovery of Respiratory System in COVID-19 Patients
An observational study of Covid19, run by Mayo Clinic at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Feb 2022to 8 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Individuals with pacemakers or other implantable devices that will make interpreting a CT scan challenging.
- Individuals with major limitations to exercise.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
Official title: Tracking the Recovery of Respiratory Physiology in COVID-19 Patients a Pilot Study
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.
Read the 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.
- Conditions
- Covid19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in diffusion capacity of the lungs
change in diffusing capacity of the lungs for carbon monoxide and its components
Measured: through study completion, an average of 5 months
Change in airway morphology
CT assessment of airway diameter and thickness
Measured: 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
Measured: through study completion, an average of 5 months
Change in peak aerobic capacity
Change in examine post exertional malaise
Measured: 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
Measured: 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.
Measured: 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
Measured: through study completion, an average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start14 Feb 2022
- Primary completion8 Jan 2024
- Study completion8 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Courtney M. Wheatley, Mayo Clinic
- Investigators
- Bruce D Johnson, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954222
- Sponsor's protocol ID
- 21-001028
- Status last verified
- Feb 2024
- First submitted
- 30 Jun 2021
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracking the Recovery of Respiratory Physiology in COVID-19 Patients a Pilot Study
- ClinicalTrials.gov ID
- NCT04954222
- Acronym / sponsor ID
- 21-001028
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 8 Jan 2024 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Individuals with pacemakers or other implantable devices that will make interpreting a CT scan challenging.
- Individuals with major limitations to exercise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Change in airway morphology
Time frame: through study completion, an average of 5 months
CT assessment of airway diameter and thickness
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 peak aerobic capacity
Time frame: through study completion, an average of 5 months
Change in examine post exertional malaise
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 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 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce D Johnson, PhD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in diffusion capacity of the lungs (time frame: through study completion, an average of 5 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.