Lung Structure-Function In Survivors of Mild and Severe COVID-19 Infection

N/AActive Not RecruitingNCT04584671

Western University, Canada100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Covid19

Interventions

Hyperpolarized Xenon-129 MRI of the lungsDIAGNOSTIC_TEST

Participants will be imaged using MRI using hyperpolarized xenon-129 gas as a contrast gas

Computed Tomography (CT)DIAGNOSTIC_TEST

Participants will undergo a CT scan of the thoracic cavity

Pulmonary Function Tests (PFT)DIAGNOSTIC_TEST

Participants will have their lung function evaluated using PFT

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Medicine (Respirology), McMaster University

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by VDP.

Measured using 129-Xenon MRI ventilation defect percent

Time frame: 1 year

Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by FEV1.

Measured using forced expiratory volume in one second (FEV1)

Time frame: 1 year

Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by FVC.

Measured using forced vital capacity (FVC)

Time frame: 1 year

Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by TLC.

Measured using total lung capacity (TLC)

Time frame: 1 year

Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by FRC.

Functional residual capacity (FRC)

Time frame: 1 year

Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by RV.

Measured using residual volume (RV)

Time frame: 1 year

Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by FOT.

Measured using forced oscillation technique (FOT)

Time frame: 1 year

Data from ClinicalTrials.gov

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Secondary Outcomes

Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by VDP.

Measured using 129-Xenon MRI ventilation defect percent