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 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.
Diagnostic Test: Hyperpolarized Xenon-129 MRI of the lungs
Participants will be imaged using MRI using hyperpolarized xenon-129 gas as a contrast gas
Other Name: 129Xe MRI
Diagnostic Test: Computed Tomography (CT)
Participants will undergo a CT scan of the thoracic cavity
Other Name: CT
Diagnostic Test: Pulmonary Function Tests (PFT)
Participants will have their lung function evaluated using PFT
Other Name: PFT
Diagnostic Test: Six Minute Walk Test (6MWT)
Participants will perform the six minute walk test as a measure of exercise capacity
Other Name: 6MWT
Diagnostic Test: Sputum analysis
Participants will provide a sputum sample that will be analysed for eosinophils
Diagnostic Test: Blood analysis
Participants will have their blood drawn and analysed for eosinophil count.
Other: Questionnaires
Participants will complete questionnaires to assess activity related dyspnea, respiratory symptoms and health status impairment and respiratory related quality of life.
Inclusion Criteria:
- Participants who are fluent in English reading, understanding and speaking
- Written informed consent must be directly obtained from legally competent participants
before any study-related assessment is performed.
- Male and female participants ≥ 18 years and < 80 years.
- Participant experienced a documented case (documented by positive COVID-19 test and/or
clinical history) of mild or severe COVID-19 infection.
- Participants are within 3 months post-recovery.
- 100 participants will have had mild symptoms.
- 100 participants will have had severe symptoms, at least 50 of whom were hospitalized.
Exclusion Criteria:
- Participants meeting contraindications for undergoing an MRI such as participants with
MRI-sensitive implants, tattoos with MRI-sensitive dye and severe claustrophobia.
- Participant is, in the opinion of the Investigator, mentally or legally incapacitated,
preventing informed consent from being obtained, or cannot read or understand written
material.
- Participant is unable to perform spirometry or plethysmography maneuvers.
Department of Medicine (Respirology), McMaster University
Hamilton, Ontario, Canada
Grace E Parraga, PhD, Principal Investigator
Robarts Research Institute, The University of Western Ontario