Recovery of Respiratory System in COVID-19 Patients

NCT04954222 | Completed

• 1 other identifier: 21-001028
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bruce D Johnson, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 8, 2021
• Study Start: February 14, 2022
• Primary Completion: January 8, 2024
• Study Completion: January 8, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

US (2)