NCT04584671

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

Lung Structure-Function In SurVivors of Mild and SEvere COVID-19 Infection: 129Xe MRI and CT For Rapid Evaluations and NExt-wave Healthcare Planning

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Western University, Canada · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid19

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Hyperpolarized Xenon-129 MRI of the lungs	Participants will be imaged using MRI using hyperpolarized xenon-129 gas as a contrast gas
DIAGNOSTIC_TEST	Computed Tomography (CT)	Participants will undergo a CT scan of the thoracic cavity
DIAGNOSTIC_TEST	Pulmonary Function Tests (PFT)	Participants will have their lung function evaluated using PFT
DIAGNOSTIC_TEST	Six Minute Walk Test (6MWT)	Participants will perform the six minute walk test as a measure of exercise capacity
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.

Timeline

• Start date: 2021-01-01
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2020-10-14
• Last updated: 2025-08-14

Locations

1 site across 1 country: Canada