Lung Structure-Function In Survivors of Mild and Severe COVID-19 Infection
NCT ID: NCT04584671
Last Updated: 2025-08-14
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
100 participants
OBSERVATIONAL
2021-01-01
2026-12-01
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Hyperpolarized Xenon-129 MRI of the lungs
Participants will be imaged using MRI using hyperpolarized xenon-129 gas as a contrast gas
Computed Tomography (CT)
Participants will undergo a CT scan of the thoracic cavity
Pulmonary Function Tests (PFT)
Participants will have their lung function evaluated using PFT
Six Minute Walk Test (6MWT)
Participants will perform the six minute walk test as a measure of exercise capacity
Sputum analysis
Participants will provide a sputum sample that will be analysed for eosinophils
Blood analysis
Participants will have their blood drawn and analysed for eosinophil count.
Questionnaires
Participants will complete questionnaires to assess activity related dyspnea, respiratory symptoms and health status impairment and respiratory related quality of life.
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.
Hyperpolarized Xenon-129 MRI of the lungs
Participants will be imaged using MRI using hyperpolarized xenon-129 gas as a contrast gas
Computed Tomography (CT)
Participants will undergo a CT scan of the thoracic cavity
Pulmonary Function Tests (PFT)
Participants will have their lung function evaluated using PFT
Six Minute Walk Test (6MWT)
Participants will perform the six minute walk test as a measure of exercise capacity
Sputum analysis
Participants will provide a sputum sample that will be analysed for eosinophils
Blood analysis
Participants will have their blood drawn and analysed for eosinophil count.
Questionnaires
Participants will complete questionnaires to assess activity related dyspnea, respiratory symptoms and health status impairment and respiratory related quality of life.
Interventions
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Hyperpolarized Xenon-129 MRI of the lungs
Participants will be imaged using MRI using hyperpolarized xenon-129 gas as a contrast gas
Computed Tomography (CT)
Participants will undergo a CT scan of the thoracic cavity
Pulmonary Function Tests (PFT)
Participants will have their lung function evaluated using PFT
Six Minute Walk Test (6MWT)
Participants will perform the six minute walk test as a measure of exercise capacity
Sputum analysis
Participants will provide a sputum sample that will be analysed for eosinophils
Blood analysis
Participants will have their blood drawn and analysed for eosinophil count.
Questionnaires
Participants will complete questionnaires to assess activity related dyspnea, respiratory symptoms and health status impairment and respiratory related quality of life.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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London Health Sciences Centre
OTHER
Western University, Canada
OTHER
Responsible Party
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Dr. Grace Parraga
PhD, Scientist. Robarts Research Institute
Principal Investigators
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Grace E Parraga, PhD
Role: PRINCIPAL_INVESTIGATOR
Robarts Research Institute, The University of Western Ontario
Locations
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Department of Medicine (Respirology), McMaster University
Hamilton, Ontario, Canada
Countries
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References
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American Health Foundation Workshop on Alcohol and Breast Cancer. December 1, 1987. Proceedings. Prev Med. 1988 Nov;17(6):667-99. No abstract available.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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ROB0050
Identifier Type: -
Identifier Source: org_study_id
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