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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04584671

Acronym

LIVECOVIDFREE

Enrollment

100

Registered

2020-10-14

Start date

2021-01-01

Completion date

2026-12-01

Last updated

2025-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

Covid19, Pulmonary Function, Xenon-129, Magnetic Resonance Imaging

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.

Interventions

DIAGNOSTIC_TESTHyperpolarized Xenon-129 MRI of the lungs

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

DIAGNOSTIC_TESTComputed Tomography (CT)

Participants will undergo a CT scan of the thoracic cavity

DIAGNOSTIC_TESTPulmonary Function Tests (PFT)

Participants will have their lung function evaluated using PFT

DIAGNOSTIC_TESTSix Minute Walk Test (6MWT)

Participants will perform the six minute walk test as a measure of exercise capacity

DIAGNOSTIC_TESTSputum analysis

Participants will provide a sputum sample that will be analysed for eosinophils

DIAGNOSTIC_TESTBlood analysis

Participants will have their blood drawn and analysed for eosinophil count.

OTHERQuestionnaires

Participants will complete questionnaires to assess activity related dyspnea, respiratory symptoms and health status impairment and respiratory related quality of life.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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 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 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.

Secondary

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026

Measure	Time frame	Description
Determine if COVID-19-induced respiratory impairment and predictors of respiratory impairment differ by sex.	up to 4 years	Evaluated by assessing different genders.
Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by FeNO.	within 3 months post COVID-19 infection recovery	Measured using Fractional Exhaled Nitric Oxide (FeNO)
Determine if COVID-19-induced respiratory impairment and predictors of respiratory impairment differ by smoking history measured in pack-years.	up to 4 years	Evaluated by assessing smoking history measured in pack-years.
Determine if COVID-19-induced respiratory impairment and predictors of respiratory impairment differ by age.	up to 4 years	Evaluated by assessing different age groups.
Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by VDP.	within 3 months post COVID-19 infection recovery	Measured using 129-Xenon MRI ventilation defect percent
Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by FEV1.	within 3 months post COVID-19 infection recovery	Measured using forced expiratory volume in one second (FEV1).
Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by FVC.	within 3 months post COVID-19 infection recovery	Measured using forced vital capacity (FVC)
Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by TLC.	within 3 months post COVID-19 infection recovery	Measured using total lung capacity (TLC)
Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by FRC.	within 3 months post COVID-19 infection recovery	Measured using functional residual capacity (FRC)
Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by RV.	within 3 months post COVID-19 infection recovery	Measured using residual volume (RV)
Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by FOT.	within 3 months post COVID-19 infection recovery	Measured using forced oscillation technique (FOT).
Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by LCI.	within 3 months post COVID-19 infection recovery	Measured using lung clearance index (LCI)
Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by exercise capacity.	within 3 months post COVID-19 infection recovery	Exercise capacity measured by six-minute walk test
Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by the baseline dyspnea index questionnaire.	within 3 months post COVID-19 infection recovery	Measured using the baseline dyspnea index questionnaire.
Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by the mMRC dyspnea scale questionnaire.	within 3 months post COVID-19 infection recovery	Measured using the modified medical research council (mMRC) dyspnea scale questionnaire
Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by CAT.	within 3 months post COVID-19 infection recovery	Measured using the COPD assessment test (CAT)
Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by SGRQ.	within 3 months post COVID-19 infection recovery	Measured using the St. George's respiratory questionnaire (SGRQ)
Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by IPAQ.	within 3 months post COVID-19 infection recovery	Measured using the International Physical Activity Questionnaire (IPAQ).
Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by eosinophil count..	within 3 months post COVID-19 infection recovery	Measured using blood and sputum eosinophil count.