Department of Medicine (Respirology), McMaster University
Hamilton, Ontario, Canada
NCT Number: NCT04584671
This is a longitudinal study of the long-term impact of COVID-19 on the lungs. Participants will be followed over a period of up to 4 years and impacts of COVID-19 on the lungs will be measured with magnetic resonance imaging (MRI) using hyperpolarized xenon-129, pulmonary function tests, exercise capacity, computed tomography imaging and questionnaires.
This study is active but is not currently recruiting participants.
Notify Me18 year–80 year
All sexes
Observational
Hamilton, Ontario, Canada
This is a multisite longitudinal study of the long-term lung health impact of COVID-19 using hyperpolarized xenon-129 (129Xe) magnetic resonance imaging (MRI) over a period of up to 4 years.
In total 200 participants age ≥ 18 and <80 years who experienced a documented case of COVID-19 (documented by positive COVID-19 test and/or clinical history) will be screened and recruited if they meet all inclusion criteria at the 5 participating sites. Participants will be grouped in mild or severe COVID-19 infection (100 in each group) including 50 with symptoms and at least 50 participants who were hospitalized with COVID-19 infection, all of whom are within 3 months post recovery and non-infectious. Participants will attend up to 5 study visits over the 4 year period. (Visit 1 within 3 months post-COVID-19 recovery, Visit 2 at 24 ± 4 weeks, Visit 3 at 48 ± 4 weeks, Visit 4 at 78 ± 4 weeks, Visit 5 at 200 ± 16 weeks)
At all visits, participants will complete 129Xe MRI, questionnaires (St. George's Respiratory Questionnaire, COPD Assessment Test, Modified Medical Research Council Dyspnea Scale, Modified Borg Scale Breathlessness and Fatigue Questionnaire, Baseline Dyspnea Index Questionnaire and International Physical Activity Questionnaire), pulmonary function tests (Spirometry, Plethysmography, Forced Oscillation Technique, Fractional Exhaled Nitric Oxide, and Multiple Breath Nitrogen Washout), blood and sputum analysis, exercise testing (six-minute walk test). At Visit 1, participants will also complete computed tomography imaging at University Hospital, London Health Sciences Centre. Visits 2 and 4 have the option of being completed over the phone, in which case only questionnaires will be completed. Visit 5 is an optional 4-year follow-up.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be imaged using MRI using hyperpolarized xenon-129 gas as a contrast gas
Other names: 129Xe MRI
Participants will undergo a CT scan of the thoracic cavity
Other names: CT
Participants will have their lung function evaluated using PFT
Other names: PFT
Participants will perform the six minute walk test as a measure of exercise capacity
Other names: 6MWT
Participants will provide a sputum sample that will be analysed for eosinophils
Participants will have their blood drawn and analysed for eosinophil count.
Participants will complete questionnaires to assess activity related dyspnea, respiratory symptoms and health status impairment and respiratory related quality of life.
Time frame: 1 year
Measured using 129-Xenon MRI ventilation defect percent
Time frame: 1 year
Measured using forced expiratory volume in one second (FEV1)
Time frame: 1 year
Measured using forced vital capacity (FVC)
Time frame: 1 year
Measured using total lung capacity (TLC)
Time frame: 1 year
Functional residual capacity (FRC)
Time frame: 1 year
Measured using residual volume (RV)
Time frame: 1 year
Measured using forced oscillation technique (FOT)
Time frame: 1 year
Measured using lung clearance index (LCI)
Time frame: 1 year
Measured using Fractional Exhaled Nitric Oxide (FeNO).
Time frame: 1 year
Exercise capacity measured by six-minute walk test
Time frame: 1 year
Measured using the baseline dyspnea index questionnaire.
Time frame: 1 year
Measured using the modified medical research council (mMRC) dyspnea scale questionnaire.
Time frame: 1 year
Measured using the COPD assessment test (CAT).
Time frame: 1 year
Measured using the St. George's respiratory questionnaire (SGRQ).
Time frame: 1 year
Measured using the International Physical Activity Questionnaire (IPAQ).
Time frame: 1 year
Measured using blood and sputum eosinophil count.
Time frame: within 3 months post COVID-19 infection recovery
Measured using 129-Xenon MRI ventilation defect percent
Time frame: within 3 months post COVID-19 infection recovery
Measured using forced expiratory volume in one second (FEV1).
Time frame: within 3 months post COVID-19 infection recovery
Measured using forced vital capacity (FVC)
Time frame: within 3 months post COVID-19 infection recovery
Measured using total lung capacity (TLC)
Time frame: within 3 months post COVID-19 infection recovery
Measured using functional residual capacity (FRC)
Time frame: within 3 months post COVID-19 infection recovery
Measured using residual volume (RV)
Time frame: within 3 months post COVID-19 infection recovery
Measured using forced oscillation technique (FOT).
Time frame: within 3 months post COVID-19 infection recovery
Measured using lung clearance index (LCI)
Time frame: within 3 months post COVID-19 infection recovery
Measured using Fractional Exhaled Nitric Oxide (FeNO)
Time frame: within 3 months post COVID-19 infection recovery
Exercise capacity measured by six-minute walk test
Time frame: within 3 months post COVID-19 infection recovery
Measured using the baseline dyspnea index questionnaire.
Time frame: within 3 months post COVID-19 infection recovery
Measured using the modified medical research council (mMRC) dyspnea scale questionnaire
Time frame: within 3 months post COVID-19 infection recovery
Measured using the COPD assessment test (CAT)
Time frame: within 3 months post COVID-19 infection recovery
Measured using the St. George's respiratory questionnaire (SGRQ)
Time frame: within 3 months post COVID-19 infection recovery
Measured using the International Physical Activity Questionnaire (IPAQ).
Time frame: within 3 months post COVID-19 infection recovery
Measured using blood and sputum eosinophil count.
Time frame: up to 4 years
Evaluated by assessing different genders.
Time frame: up to 4 years
Evaluated by assessing different age groups.
Time frame: up to 4 years
Evaluated by assessing smoking history measured in pack-years.
Western University, Canada
Other
Lung Structure-Function In SurVivors of Mild and SEvere COVID-19 Infection: 129Xe MRI and CT For Rapid Evaluations and NExt-wave Healthcare Planning
Acronym: LIVECOVIDFREE
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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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