Recovery of Respiratory System in COVID-19 Patients

NCT ID: NCT04954222

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-14

Study Completion Date

2024-01-08

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.

Conditions

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Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID19 long haulers

Individuals that have been diagnosed with COVID19 and continue to have lingering symptoms associated with COVID19

No interventions assigned to this group

COVID19 no residual symptoms

Individuals that have been diagnosed with COVID19 and do not have lingering symptoms that are associated with COVID19

No interventions assigned to this group

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Courtney M. Wheatley

Co-Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruce D Johnson, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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21-001028

Identifier Type: -

Identifier Source: org_study_id

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