Covid19LIVECOVIDFREENCT04584671

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

An observational study of Covid19, run by Western University, Canada at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial 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… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Covid19
What is being tested?: Hyperpolarized Xenon-129 MRI of the lungs, Computed Tomography (CT) and Pulmonary Function Tests (PFT)
How many people: 100 participants
Where: 1 siteCanada
Study dates: 1 Jan 2021to 1 Dec 2026
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Participants who experienced a documented mild or severe COVID-19 infection

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Department of Medicine (Respirology), McMaster University
Hamilton, Ontario

Other trials in Canada

About this study

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

Read the 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
Being tested: Hyperpolarized Xenon-129 MRI of the lungs, Computed Tomography (CT), Pulmonary Function Tests (PFT), Six Minute Walk Test (6MWT), Sputum analysis
Keywords: Covid19, Pulmonary Function, Xenon-129, Magnetic Resonance Imaging
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hyperpolarized Xenon-129 MRI of the lungsDiagnostic test
Also called 129Xe MRI
Participants will be imaged using MRI using hyperpolarized xenon-129 gas as a contrast gas
Computed Tomography (CT)Diagnostic test
Also called CT
Participants will undergo a CT scan of the thoracic cavity
Pulmonary Function Tests (PFT)Diagnostic test
Also called PFT
Participants will have their lung function evaluated using PFT
Six Minute Walk Test (6MWT)Diagnostic test
Also called 6MWT
Participants will perform the six minute walk test as a measure of exercise capacity
Sputum analysisDiagnostic test
Participants will provide a sputum sample that will be analysed for eosinophils
Blood analysisDiagnostic test
Participants will have their blood drawn and analysed for eosinophil count.
QuestionnairesOther
Participants will complete questionnaires to assess activity related dyspnea, respiratory symptoms and health status impairment and respiratory related quality of life.

Study groups in NCT04584671
Study group	Role	What they receive
Mild COVID-19 Infection Group		100 participants age ≥ 18 and <80 years who experienced a documented case (documented by positive COVID-19 test and/or clinical history) of mild COVID-19 infection, all of whom are within 3 months post recovery and non-infectious. Receives: Diagnostic Test: Hyperpolarized Xenon-129 MRI of the lungs; Diagnostic Test: Computed Tomography (CT); Diagnostic Test: Pulmonary Function Tests (PFT); Diagnostic Test: Six Minute Walk Test (6MWT); Diagnostic Test: Sputum analysis; Diagnostic Test: Blood analysis; Other: Questionnaires
Severe COVID-19 Infection Group		100 participants age ≥ 18 and <80 years who experienced a documented case (documented by positive COVID-19 test and/or clinical history) of severe COVID-19 infection, including at least 50 participants who were hospitalized with COVID-19 infection, all of whom are within 3 months post recovery and non-infectious. Receives: Diagnostic Test: Hyperpolarized Xenon-129 MRI of the lungs; Diagnostic Test: Computed Tomography (CT); Diagnostic Test: Pulmonary Function Tests (PFT); Diagnostic Test: Six Minute Walk Test (6MWT); Diagnostic Test: Sputum analysis; Diagnostic Test: Blood analysis; Other: Questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 1 year
Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by LCI.
Measured using lung clearance index (LCI)
Measured: 1 year
Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by FeNO.
Measured using Fractional Exhaled Nitric Oxide (FeNO).
Measured: 1 year
Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by exercise capacity.
Exercise capacity measured by six-minute walk test
Measured: 1 year
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
Measured using the baseline dyspnea index questionnaire.
Measured: 1 year
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.
Measured using the modified medical research council (mMRC) dyspnea scale questionnaire.
Measured: 1 year
Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by CAT.
Measured using the COPD assessment test (CAT).
Measured: 1 year
Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by SGRQ.
Measured using the St. George's respiratory questionnaire (SGRQ).
Measured: 1 year
Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by IPAQ.
Measured using the International Physical Activity Questionnaire (IPAQ).
Measured: 1 year
Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by eosinophil count.
Measured using blood and sputum eosinophil count.
Measured: 1 year

Secondary outcomes (19)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20211 Dec 2026

First posted14 Oct 2020
Study start1 Jan 2021
Primary completion1 Sep 2026 (estimated)
Study completion1 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Covid19Studies of the same condition, open and under way.
More trials run by Western University, CanadaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04584671
Sponsor's protocol ID: ROB0050
Acronym: LIVECOVIDFREE
Status last verified: Aug 2025
First submitted: 7 Oct 2020
Last updated: 14 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Driehuys B, Martinez-Jimenez S, Cleveland ZI, Metz GM, Beaver DM, Nouls JC, Kaushik SS, Firszt R, Willis C, Kelly KT, Wolber J, Kraft M, McAdams HP. Chronic obstructive pulmonary disease: safety and tolerability of hyperpolarized 129Xe MR imaging in healthy volunteers and patients. Radiology. 2012 Jan;262(1):279-89. doi: 10.1148/radiol.11102172. Epub 2011 Nov 4.
PubMed 22056683
Shukla Y, Wheatley A, Kirby M, Svenningsen S, Farag A, Santyr GE, Paterson NA, McCormack DG, Parraga G. Hyperpolarized 129Xe magnetic resonance imaging: tolerability in healthy volunteers and subjects with pulmonary disease. Acad Radiol. 2012 Aug;19(8):941-51. doi: 10.1016/j.acra.2012.03.018. Epub 2012 May 15.
PubMed 22591724
Schmidt MH, Marshall J, Downie J, Hadskis MR. Pediatric magnetic resonance research and the minimal-risk standard. IRB. 2011 Sep-Oct;33(5):1-6. No abstract available.
PubMed 22043743
Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
PubMed 16055882
Oostveen E, MacLeod D, Lorino H, Farre R, Hantos Z, Desager K, Marchal F; ERS Task Force on Respiratory Impedance Measurements. The forced oscillation technique in clinical practice: methodology, recommendations and future developments. Eur Respir J. 2003 Dec;22(6):1026-41. doi: 10.1183/09031936.03.00089403.
PubMed 14680096
Kirby M, Heydarian M, Svenningsen S, Wheatley A, McCormack DG, Etemad-Rezai R, Parraga G. Hyperpolarized 3He magnetic resonance functional imaging semiautomated segmentation. Acad Radiol. 2012 Feb;19(2):141-52. doi: 10.1016/j.acra.2011.10.007. Epub 2011 Nov 21.
PubMed 22104288
Owrangi AM, Etemad-Rezai R, McCormack DG, Cunningham IA, Parraga G. Computed tomography density histogram analysis to evaluate pulmonary emphysema in ex-smokers. Acad Radiol. 2013 May;20(5):537-45. doi: 10.1016/j.acra.2012.11.010.
PubMed 23570935
Pizzichini E, Pizzichini MM, Efthimiadis A, Evans S, Morris MM, Squillace D, Gleich GJ, Dolovich J, Hargreave FE. Indices of airway inflammation in induced sputum: reproducibility and validity of cell and fluid-phase measurements. Am J Respir Crit Care Med. 1996 Aug;154(2 Pt 1):308-17. doi: 10.1164/ajrccm.154.2.8756799.
PubMed 8756799
McGavin CR, Artvinli M, Naoe H, McHardy GJ. Dyspnoea, disability, and distance walked: comparison of estimates of exercise performance in respiratory disease. Br Med J. 1978 Jul 22;2(6132):241-3. doi: 10.1136/bmj.2.6132.241.
PubMed 678885
Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509.
PubMed 19720809
Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire. Am Rev Respir Dis. 1992 Jun;145(6):1321-7. doi: 10.1164/ajrccm/145.6.1321.
PubMed 1595997
Matheson AM, McIntosh MJ, Kooner HK, Abdelrazek M, Albert MS, Dhaliwal I, Nicholson JM, Ouriadov A, Svenningsen S, Parraga G. Longitudinal follow-up of postacute COVID-19 syndrome: DLCO, quality-of-life and MRI pulmonary gas-exchange abnormalities. Thorax. 2023 Apr;78(4):418-421. doi: 10.1136/thorax-2022-219378. Epub 2023 Jan 3.
PubMed 36596692
Matheson AM, McIntosh MJ, Kooner HK, Lee J, Desaigoudar V, Bier E, Driehuys B, Svenningsen S, Santyr GE, Kirby M, Albert MS, Shepelytskyi Y, Grynko V, Ouriadov A, Abdelrazek M, Dhaliwal I, Nicholson JM, Parraga G. Persistent 129Xe MRI Pulmonary and CT Vascular Abnormalities in Symptomatic Individuals with Post-acute COVID-19 Syndrome. Radiology. 2022 Nov;305(2):466-476. doi: 10.1148/radiol.220492. Epub 2022 Jun 28.
PubMed 35762891

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04584671
Acronym / sponsor ID: LIVECOVIDFREE / ROB0050
Conditions: Covid19
Keywords: Covid19, Pulmonary Function, Xenon-129, Magnetic Resonance Imaging
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 100 participants (estimated)
Lead sponsor: Western University, CanadaUniversity, hospital or other
Collaborators: London Health Sciences Centre
Study start: 1 Jan 2021 (actual)
Primary completion: 1 Sep 2026 (estimated)
Study completion: 1 Dec 2026 (estimated)
First posted: 14 Oct 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Mild COVID-19 Infection Group	–	Diagnostic Test: Hyperpolarized Xenon-129 MRI of the lungs, Diagnostic Test: Computed Tomography (CT), Diagnostic Test: Pulmonary Function Tests (PFT), Diagnostic Test: Six Minute Walk Test (6MWT), Diagnostic Test: Sputum analysis, Diagnostic Test: Blood analysis, Other: Questionnaires100 participants age ≥ 18 and <80 years who experienced a documented case (documented by positive COVID-19 test and/or clinical history) of mild COVID-19 infection, all of whom are within 3 months post recovery and non-infectious.
Severe COVID-19 Infection Group	–	Diagnostic Test: Hyperpolarized Xenon-129 MRI of the lungs, Diagnostic Test: Computed Tomography (CT), Diagnostic Test: Pulmonary Function Tests (PFT), Diagnostic Test: Six Minute Walk Test (6MWT), Diagnostic Test: Sputum analysis, Diagnostic Test: Blood analysis, Other: Questionnaires100 participants age ≥ 18 and <80 years who experienced a documented case (documented by positive COVID-19 test and/or clinical history) of severe COVID-19 infection, including at least 50 participants who were hospitalized with COVID-19 infection, all of whom are within 3 months post recovery and non-infectious.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants who experienced a documented mild or severe COVID-19 infection

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hyperpolarized Xenon-129 MRI of the lungsAlso: 129Xe MRIParticipants will be imaged using MRI using hyperpolarized xenon-129 gas as a contrast gas	Diagnostic test	Mild COVID-19 Infection Group, Severe COVID-19 Infection Group
Computed Tomography (CT)Also: CTParticipants will undergo a CT scan of the thoracic cavity	Diagnostic test	Mild COVID-19 Infection Group, Severe COVID-19 Infection Group
Pulmonary Function Tests (PFT)Also: PFTParticipants will have their lung function evaluated using PFT	Diagnostic test	Mild COVID-19 Infection Group, Severe COVID-19 Infection Group
Six Minute Walk Test (6MWT)Also: 6MWTParticipants will perform the six minute walk test as a measure of exercise capacity	Diagnostic test	Mild COVID-19 Infection Group, Severe COVID-19 Infection Group
Sputum analysisParticipants will provide a sputum sample that will be analysed for eosinophils	Diagnostic test	Mild COVID-19 Infection Group, Severe COVID-19 Infection Group
Blood analysisParticipants will have their blood drawn and analysed for eosinophil count.	Diagnostic test	Mild COVID-19 Infection Group, Severe COVID-19 Infection Group
QuestionnairesParticipants will complete questionnaires to assess activity related dyspnea, respiratory symptoms and health status impairment and respiratory related quality of life.	Other	Mild COVID-19 Infection Group, Severe COVID-19 Infection Group

Primary outcome

Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by VDP.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 year
Measured using blood and sputum eosinophil count.

19 secondary outcomes

Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by VDP.
Time frame: within 3 months post COVID-19 infection recovery
Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by FEV1.
Time frame: within 3 months post COVID-19 infection recovery
Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by FVC.
Time frame: within 3 months post COVID-19 infection recovery
Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by TLC.
Time frame: within 3 months post COVID-19 infection recovery
Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by FRC.
Time frame: within 3 months post COVID-19 infection recovery
Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by RV.
Time frame: within 3 months post COVID-19 infection recovery
Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by FOT.
Time frame: within 3 months post COVID-19 infection recovery
Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by LCI.
Time frame: within 3 months post COVID-19 infection recovery
Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by FeNO.
Time frame: within 3 months post COVID-19 infection recovery
Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by exercise capacity.
Time frame: within 3 months post COVID-19 infection recovery
Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by the baseline dyspnea index questionnaire.
Time frame: within 3 months post COVID-19 infection recovery
Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by the mMRC dyspnea scale questionnaire.
Time frame: within 3 months post COVID-19 infection recovery
Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by CAT.
Time frame: within 3 months post COVID-19 infection recovery
Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by SGRQ.
Time frame: within 3 months post COVID-19 infection recovery
Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by IPAQ.
Time frame: within 3 months post COVID-19 infection recovery
Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by eosinophil count..
Time frame: within 3 months post COVID-19 infection recovery
Determine if COVID-19-induced respiratory impairment and predictors of respiratory impairment differ by sex.
Time frame: up to 4 years
Determine if COVID-19-induced respiratory impairment and predictors of respiratory impairment differ by age.
Time frame: up to 4 years
Determine if COVID-19-induced respiratory impairment and predictors of respiratory impairment differ by smoking history measured in pack-years.
Time frame: up to 4 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
Background: PubMed 22056683Driehuys B, Martinez-Jimenez S, Cleveland ZI, Metz GM, Beaver DM, Nouls JC, Kaushik SS, Firszt R, Willis C, Kelly KT, Wolber J, Kraft M, McAdams HP. Chronic obstructive pulmonary disease: safety and tolerability of hyperpolarized 129Xe MR imaging in healthy volunteers and patients. Radiology. 2012 Jan;262(1):279-89. doi: 10.1148/radiol.11102172. Epub 2011 Nov 4.
Background: PubMed 22591724Shukla Y, Wheatley A, Kirby M, Svenningsen S, Farag A, Santyr GE, Paterson NA, McCormack DG, Parraga G. Hyperpolarized 129Xe magnetic resonance imaging: tolerability in healthy volunteers and subjects with pulmonary disease. Acad Radiol. 2012 Aug;19(8):941-51. doi: 10.1016/j.acra.2012.03.018. Epub 2012 May 15.
Background: PubMed 22043743Schmidt MH, Marshall J, Downie J, Hadskis MR. Pediatric magnetic resonance research and the minimal-risk standard. IRB. 2011 Sep-Oct;33(5):1-6. No abstract available.
Background: PubMed 16055882Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
Background: PubMed 14680096Oostveen E, MacLeod D, Lorino H, Farre R, Hantos Z, Desager K, Marchal F; ERS Task Force on Respiratory Impedance Measurements. The forced oscillation technique in clinical practice: methodology, recommendations and future developments. Eur Respir J. 2003 Dec;22(6):1026-41. doi: 10.1183/09031936.03.00089403.
Background: PubMed 22104288Kirby M, Heydarian M, Svenningsen S, Wheatley A, McCormack DG, Etemad-Rezai R, Parraga G. Hyperpolarized 3He magnetic resonance functional imaging semiautomated segmentation. Acad Radiol. 2012 Feb;19(2):141-52. doi: 10.1016/j.acra.2011.10.007. Epub 2011 Nov 21.
Background: PubMed 23570935Owrangi AM, Etemad-Rezai R, McCormack DG, Cunningham IA, Parraga G. Computed tomography density histogram analysis to evaluate pulmonary emphysema in ex-smokers. Acad Radiol. 2013 May;20(5):537-45. doi: 10.1016/j.acra.2012.11.010.
Background: PubMed 8756799Pizzichini E, Pizzichini MM, Efthimiadis A, Evans S, Morris MM, Squillace D, Gleich GJ, Dolovich J, Hargreave FE. Indices of airway inflammation in induced sputum: reproducibility and validity of cell and fluid-phase measurements. Am J Respir Crit Care Med. 1996 Aug;154(2 Pt 1):308-17. doi: 10.1164/ajrccm.154.2.8756799.
Background: PubMed 678885McGavin CR, Artvinli M, Naoe H, McHardy GJ. Dyspnoea, disability, and distance walked: comparison of estimates of exercise performance in respiratory disease. Br Med J. 1978 Jul 22;2(6132):241-3. doi: 10.1136/bmj.2.6132.241.
Background: PubMed 19720809Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509.
Background: PubMed 1595997Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire. Am Rev Respir Dis. 1992 Jun;145(6):1321-7. doi: 10.1164/ajrccm/145.6.1321.
Derived from this study: PubMed 36596692Matheson AM, McIntosh MJ, Kooner HK, Abdelrazek M, Albert MS, Dhaliwal I, Nicholson JM, Ouriadov A, Svenningsen S, Parraga G. Longitudinal follow-up of postacute COVID-19 syndrome: DLCO, quality-of-life and MRI pulmonary gas-exchange abnormalities. Thorax. 2023 Apr;78(4):418-421. doi: 10.1136/thorax-2022-219378. Epub 2023 Jan 3.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Grace E Parraga, PhD principal investigator

Robarts Research Institute, The University of Western Ontario

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19, run by Western University, Canada at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by VDP. (time frame: 1 year). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04584671, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.