Recovery of Respiratory System in COVID-19 Patients

Mayo Clinic

Status: Completed

Conditions: Covid19

Study type: Observational

Funder types: Other

Identifiers

NCT04954222

21-001028

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

80 participants in 2 patient groups

COVID19 long haulers

Description:

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

COVID19 no residual symptoms

Description:

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