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Completed

NCT Number: NCT04954222

Recovery of Respiratory System in COVID-19 Patients

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  2. Change in airway morphology

    Time frame: through study completion, an average of 5 months

    CT assessment of airway diameter and thickness

  3. 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

  4. Change in peak aerobic capacity

    Time frame: through study completion, an average of 5 months

    Change in examine post exertional malaise

  5. 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

  6. 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.

  7. 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Tracking the Recovery of Respiratory Physiology in COVID-19 Patients a Pilot Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 8, 2021
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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