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

NCT04584671 | Active Not Recruiting

• 1 other identifier: ROB0050
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

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

Outcome Measures

Primary Outcomes (16)

• 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

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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).

  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

  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.

  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.

  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).

  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).

  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).

  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.

  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.

  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.

  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.

  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.

  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.

  within 3 months post COVID-19 infection recovery

Study Arms (2)

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.

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.

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

Interventions

Hyperpolarized Xenon-129 MRI of the lungs DIAGNOSTIC_TEST

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

Also known as: 129Xe MRI

Mild COVID-19 Infection Group; Severe COVID-19 Infection Group

Computed Tomography (CT) DIAGNOSTIC_TEST

Participants will undergo a CT scan of the thoracic cavity

Also known as: CT

Mild COVID-19 Infection Group; Severe COVID-19 Infection Group

Pulmonary Function Tests (PFT) DIAGNOSTIC_TEST

Participants will have their lung function evaluated using PFT

Also known as: PFT

Mild COVID-19 Infection Group; Severe COVID-19 Infection Group

Six Minute Walk Test (6MWT) DIAGNOSTIC_TEST

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

Also known as: 6MWT

Mild COVID-19 Infection Group; Severe COVID-19 Infection Group

Sputum analysis DIAGNOSTIC_TEST

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

Mild COVID-19 Infection Group; Severe COVID-19 Infection Group

Blood analysis DIAGNOSTIC_TEST

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

Mild COVID-19 Infection Group; Severe COVID-19 Infection Group

Questionnaires OTHER

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

Mild COVID-19 Infection Group; Severe COVID-19 Infection Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.
• participants will have had mild symptoms.
• participants will have had severe symptoms, at least 50 of whom were hospitalized.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western University, Canada: lead
• London Health Sciences Centre: collaborator

Study Sites (1)

Department of Medicine (Respirology), McMaster University

Hamilton, Ontario, Canada

Location

Related Publications (13)

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• 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.

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• 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.

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MeSH Terms

Conditions

COVID-19

Interventions

Tomography, X-Ray Computed; Respiratory Function Tests; Walk Test; Hematologic Tests; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography; Diagnostic Techniques, Respiratory System; Exercise Test; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Clinical Laboratory Techniques; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Grace E Parraga, PhD

  Robarts Research Institute, The University of Western Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Scientist. Robarts Research Institute

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 14, 2020
• Study Start: January 1, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)