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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04584671
Recruitment Status : Not yet recruiting
First Posted : October 14, 2020
Last Update Posted : November 13, 2020
Sponsor:
Collaborator:
London Health Sciences Centre
Information provided by (Responsible Party):
Dr. Grace Parraga, Western University, Canada

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.

Condition or disease Intervention/treatment
Covid19 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

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2024

Group/Cohort Intervention/treatment
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
Participants will be imaged using MRI using hyperpolarized xenon-129 gas as a contrast gas
Other Name: 129Xe MRI

Diagnostic Test: Computed Tomography (CT)
Participants will undergo a CT scan of the thoracic cavity
Other Name: CT

Diagnostic Test: Pulmonary Function Tests (PFT)
Participants will have their lung function evaluated using PFT
Other Name: PFT

Diagnostic Test: Six Minute Walk Test (6MWT)
Participants will perform the six minute walk test as a measure of exercise capacity
Other Name: 6MWT

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.

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
Participants will be imaged using MRI using hyperpolarized xenon-129 gas as a contrast gas
Other Name: 129Xe MRI

Diagnostic Test: Computed Tomography (CT)
Participants will undergo a CT scan of the thoracic cavity
Other Name: CT

Diagnostic Test: Pulmonary Function Tests (PFT)
Participants will have their lung function evaluated using PFT
Other Name: PFT

Diagnostic Test: Six Minute Walk Test (6MWT)
Participants will perform the six minute walk test as a measure of exercise capacity
Other Name: 6MWT

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.




Primary Outcome Measures :
  1. 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

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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).

  10. 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

  11. 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.

  12. 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.

  13. 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).

  14. 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).

  15. 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).

  16. 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.


Secondary Outcome Measures :
  1. 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 ]
    Measured using 129-Xenon MRI ventilation defect percent

  2. 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 ]
    Measured using forced expiratory volume in one second (FEV1).

  3. 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 ]
    Measured using forced vital capacity (FVC)

  4. 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 ]
    Measured using total lung capacity (TLC)

  5. 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 ]
    Measured using functional residual capacity (FRC)

  6. 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 ]
    Measured using residual volume (RV)

  7. 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 ]
    Measured using forced oscillation technique (FOT).

  8. 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 ]
    Measured using lung clearance index (LCI)

  9. 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 ]
    Measured using Fractional Exhaled Nitric Oxide (FeNO)

  10. 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 ]
    Exercise capacity measured by six-minute walk test

  11. 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 ]
    Measured using the baseline dyspnea index questionnaire.

  12. 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 ]
    Measured using the modified medical research council (mMRC) dyspnea scale questionnaire

  13. 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 ]
    Measured using the COPD assessment test (CAT)

  14. 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 ]
    Measured using the St. George's respiratory questionnaire (SGRQ)

  15. 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 ]
    Measured using the International Physical Activity Questionnaire (IPAQ).

  16. 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 ]
    Measured using blood and sputum eosinophil count.

  17. Determine if COVID-19-induced respiratory impairment and predictors of respiratory impairment differ by sex. [ Time Frame: up to 4 years ]
    Evaluated by assessing different genders.

  18. Determine if COVID-19-induced respiratory impairment and predictors of respiratory impairment differ by age. [ Time Frame: up to 4 years ]
    Evaluated by assessing different age groups.

  19. 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 ]
    Evaluated by assessing smoking history measured in pack-years.



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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants who experienced a documented mild or severe COVID-19 infection
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04584671


Contacts
Layout table for location contacts
Contact: Grace E Parraga, PhD (519) 931-5265 gparraga@robarts.ca
Contact: Angela Wilson, RRT 519-931-5777 ext 24197 awilson@robarts.ca

Locations
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Canada, Ontario
Department of Medicine (Respirology), McMaster University
Hamilton, Ontario, Canada
Contact: Sarah Svenningsen, PhD         
Sponsors and Collaborators
Western University, Canada
London Health Sciences Centre
Investigators
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Principal Investigator: Grace E Parraga, PhD Robarts Research Institute, The University of Western Ontario
Publications:

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Responsible Party: Dr. Grace Parraga, PhD, Scientist. Robarts Research Institute, Western University, Canada
ClinicalTrials.gov Identifier: NCT04584671    
Other Study ID Numbers: ROB0050
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Grace Parraga, Western University, Canada:
Covid19
Pulmonary Function
Xenon-129
Magnetic Resonance Imaging
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Xenon
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs