Clinical trial NCT04584671: Lung Structure-Function In Survivors of Mild and Severe COVID-19 Infection
Official title: Lung Structure-Function In SurVivors of Mild and SEvere COVID-19 Infection: 129Xe MRI and CT For Rapid Evaluations and NExt-wave Healthcare Planning
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Covid19
Keywords: Covid19
Pulmonary Function
Xenon-129
Magnetic Resonance Imaging
Lead sponsor: Western University, Canada
Sponsor class: OTHER
Collaborators: name: London Health Sciences Centre
First posted: 2020-10-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants who experienced a documented mild or severe COVID-19 infection

Brief 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.

Detailed description: 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.

Eligibility criteria: 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 outcomes:
measure: Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by VDP.
timeFrame: 1 year
measure: Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by FEV1.
timeFrame: 1 year
measure: Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by FVC.
timeFrame: 1 year
measure: Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by TLC.
timeFrame: 1 year
measure: Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by FRC.
timeFrame: 1 year
measure: Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by RV.
timeFrame: 1 year
measure: Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by FOT.
timeFrame: 1 year
measure: Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by LCI.
timeFrame: 1 year
measure: Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by FeNO.
timeFrame: 1 year
measure: Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by exercise capacity.
timeFrame: 1 year
measure: 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
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
measure: Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by CAT.
timeFrame: 1 year
measure: Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by SGRQ.
timeFrame: 1 year
measure: Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by IPAQ.
timeFrame: 1 year
measure: Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by eosinophil count.
timeFrame: 1 year
Secondary outcomes:
measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by VDP.
timeFrame: within 3 months post COVID-19 infection recovery
measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by FEV1.
timeFrame: within 3 months post COVID-19 infection recovery
measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by FVC.
timeFrame: within 3 months post COVID-19 infection recovery
measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by TLC.
timeFrame: within 3 months post COVID-19 infection recovery
measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by FRC.
timeFrame: within 3 months post COVID-19 infection recovery
measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by RV.
timeFrame: within 3 months post COVID-19 infection recovery
measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by FOT.
timeFrame: within 3 months post COVID-19 infection recovery
measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by LCI.
timeFrame: within 3 months post COVID-19 infection recovery
measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by FeNO.
timeFrame: within 3 months post COVID-19 infection recovery
measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by exercise capacity.
timeFrame: within 3 months post COVID-19 infection recovery
measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by the baseline dyspnea index questionnaire.
timeFrame: within 3 months post COVID-19 infection recovery
measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by the mMRC dyspnea scale questionnaire.
timeFrame: within 3 months post COVID-19 infection recovery
measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by CAT.
timeFrame: within 3 months post COVID-19 infection recovery
measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by SGRQ.
timeFrame: within 3 months post COVID-19 infection recovery
measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by IPAQ.
timeFrame: within 3 months post COVID-19 infection recovery
measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by eosinophil count..
timeFrame: within 3 months post COVID-19 infection recovery
measure: Determine if COVID-19-induced respiratory impairment and predictors of respiratory impairment differ by sex.
timeFrame: up to 4 years
measure: Determine if COVID-19-induced respiratory impairment and predictors of respiratory impairment differ by age.
timeFrame: up to 4 years
measure: Determine if COVID-19-induced respiratory impairment and predictors of respiratory impairment differ by smoking history measured in pack-years.
timeFrame: up to 4 years
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Department of Medicine (Respirology), McMaster University
state: Ontario
Study officials:
affiliation: Robarts Research Institute, The University of Western Ontario
name: Grace E Parraga, PhD
role: PRINCIPAL_INVESTIGATOR
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