Recovery of Respiratory System in COVID-19 Patients

Completed

• Conditions: Covid19

• Registration Number: NCT04954222
• Lead Sponsor: Mayo Clinic

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 Timeline

• Study First Submitted: 2021-06-30
• Study First Submitted QC: 2021-07-06
• Study First Posted: 2021-07-08
• Study Start: 2022-02-14
• Primary Completion: 2024-01-08
• Study Completion: 2024-01-08
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

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Exclusion Criteria

• Individuals with pacemakers or other implantable devices that will make interpreting a CT scan challenging.
• Individuals with major limitations to exercise.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in quality of life	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	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	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	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	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	through study completion, an average of 5 months	CT assessment of airway diameter and thickness
Change in peak aerobic capacity	through study completion, an average of 5 months	Change in examine post exertional malaise

Trial Locations

Locations (2)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States