Recovery of Respiratory System in COVID-19 Patients

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04954222
• Other study ID #: 21-001028
• Status: Completed
• Start date: February 14, 2022
• Est. completion date: January 8, 2024

Study information

• Verified date: February 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 8, 2024
• Est. primary completion date: January 8, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in airway morphology	CT assessment of airway diameter and thickness	through study completion, an average of 5 months
Primary	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
Primary	Change in peak aerobic capacity	Change in examine post exertional malaise	through study completion, an average of 5 months
Primary	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
Primary	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
Primary	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

External Links

•   Mayo Clinic Clinical Trials