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 onthe lungs will be measured with magnetic resonance imaging (MRI) using hyperpolarizedxenon-129, pulmonary function tests, exercise capacity, computed tomography imaging andquestionnaires.
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