Hyperpolarized Xenon-129 MRI of the lungsComputed Tomography (CT)Pulmonary Function Tests (PFT)Six Minute Walk Test (6MWT)Sputum analysisBlood analysisQuestionnaires
Hyperpolarized Xenon-129 MRI of the lungs: Participants will be imaged using MRI using hyperpolarized xenon-129 gas as a contrast gas
Computed Tomography (CT): Participants will undergo a CT scan of the thoracic cavity
Pulmonary Function Tests (PFT): Participants will have their lung function evaluated using PFT
Six Minute Walk Test (6MWT): Participants will perform the six minute walk test as a measure of exercise capacity
Sputum analysis: Participants will provide a sputum sample that will be analysed for eosinophils
Blood analysis: Participants will have their blood drawn and analysed for eosinophil count.
Questionnaires: Participants will complete questionnaires to assess activity related dyspnea, respiratory symptoms and health status impairment and respiratory related quality of life.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by VDP. — 1 year Measured using 129-Xenon MRI ventilation defect percent
Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by FEV1. — 1 year Measured using forced expiratory volume in one second (FEV1)
Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by FVC. — 1 year Measured using forced vital capacity (FVC)
Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by TLC. — 1 year Measured using total lung capacity (TLC)
Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by FRC. — 1 year Functional residual capacity (FRC)
Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by RV. — 1 year Measured using residual volume (RV)
Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by FOT. — 1 year Measured using forced oscillation technique (FOT)
Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by LCI. — 1 year Measured using lung clearance index (LCI)
Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by FeNO. — 1 year Measured using Fractional Exhaled Nitric Oxide (FeNO).
Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by exercise capacity. — 1 year Exercise capacity measured by six-minute walk test
Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by baseline dyspnea index questionnaire — 1 year Measured using the baseline dyspnea index questionnaire.
Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by (mMRC) dyspnea scale questionnaire. — 1 year Measured using the modified medical research council (mMRC) dyspnea scale questionnaire.
Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by CAT. — 1 year Measured using the COPD assessment test (CAT).
Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by SGRQ. — 1 year Measured using the St. George's respiratory questionnaire (SGRQ).
Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by IPAQ. — 1 year Measured using the International Physical Activity Questionnaire (IPAQ).
Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by eosinophil count. — 1 year Measured using blood and sputum eosinophil count.
Trial sites (1)
Facility
City
Region
Status
Department of Medicine (Respirology), McMaster University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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