Recovery of Respiratory System in COVID-19 Patients

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.

Study Overview

• Status: Completed
• Conditions: Covid19

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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic in Arizona
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in diffusion capacity of the lungs	change in diffusing capacity of the lungs for carbon monoxide and its components	through study completion, an average of 5 months
Change in airway morphology	CT assessment of airway diameter and thickness	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	through study completion, an average of 5 months
Change in peak aerobic capacity	Change in examine post exertional malaise	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	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.	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	through study completion, an average of 5 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Bruce D Johnson, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2022
• Primary Completion (Actual): January 8, 2024
• Study Completion (Actual): January 8, 2024

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: July 6, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 21-001028

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No