We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Lung Structure-Function In SurVivors of Mild and SEvere COVID-19 Infection: 129Xe MRI (LivCovidFree)

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: NCT05014516
Recruitment Status : Recruiting
First Posted : August 20, 2021
Last Update Posted : September 22, 2022
Sponsor:
Collaborator:
Western University
Information provided by (Responsible Party):
Giles Santyr, The Hospital for Sick Children

Brief Summary:
In this study the Investigators aim to deploy UTE and HP 129Xe MRI for structural and functional evaluation of persistent lung abnormalities in COVID-19 survivors.

Condition or disease Intervention/treatment
COVID-19 Respiratory Infection Drug: 129Xenon gas

Detailed Description:

What is COVID-19? The ongoing Coronavirus Disease 2019 (COVID-19) pandemic is caused when an individual is infected with the SARS-CoV-2 virus. This infection can result in pneumonia involving the small airways and alveoli (the tiny air sacs at the end of the airways that help oxygen get into the blood). COVID-19 can cause damage to the lungs, making it hard to breathe without medical help. To understand what is happening to a patient's lungs, doctors may use imaging tests such as chest x-rays or CT Scans (computed tomography). However, these types of tests may not tell the Investigators the whole story.

What is the purpose of the study? Led by The Hospital for Sick Children (SickKids), this study is being done to determine if MRI (magnetic resonance imaging) scans can tell the Investigators more about the lungs of people who had COVID-19. The Investigators will use a special type of MRI where participants breathe in a special gas (hyperpolarized xenon-129) before they have the MRI. This gas will help the Investigators to see' the lungs. The advantage of MRI scans is that there is no radiation involved in these types of images.

What is involved? In this study, participants will have an MRI of their lungs. The Investigators will examine these MRI scans to see if the Investigators can identify any changes in the structure or the function of the lung. If the Investigators do find any changes, they will see how these changes relate to other tests that have been conducted or other parts of the clinical story.

The participants will be asked to come to SickKids for 3 study visits. A fourth visit will be conducted via telephone. These visits will span over 3 years. Each study visit will take about 4 hours. If the participant is unable to attend one of the in-person visits, they will be given the option for a phone/virtual visit instead.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lung Structure-Function In SurVivors of Mild and SEvere COVID-19 Infection: 129Xe MRI For Rapid Evaluation and NExt-wave Healthcare Planning
Actual Study Start Date : August 5, 2021
Estimated Primary Completion Date : June 15, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Xenon

Group/Cohort Intervention/treatment
Single arm
Those participants who have experienced a documented case (documented by positive COVID19 test and/or clinical history) mild or severe COVID19 infection including those with symptoms and those who were hospitalized with COVID19 infection, all of whom are within 3 months post recovery
Drug: 129Xenon gas
Observational
Other Name: Hyperpolarized tracer gas




Primary Outcome Measures :
  1. Primary [ Time Frame: 4 years ]
    Determine if 129Xenon MRI can detect abnormalities in COVID19 survivors 3 months, 6 months, 1 year and 2 years post infection.


Secondary Outcome Measures :
  1. Secondary 2A (i) [ Time Frame: 3.5 years ]
    Pulmonary function test: Spirometry to measure FEV1 (L)

  2. Secondary 2A (ii) [ Time Frame: 3.5 years ]
    Pulmonary function test: Plethysmography/Lung volumes to measure TLC (L)

  3. Secondary 2A (iii) [ Time Frame: 3.5 years ]
    Pulmonary function test: Diffusing Capacity Of The Lungs For Carbon Monoxide to measure DLCO

  4. Secondary 2B [ Time Frame: 3.5years ]
    6 minute walk test - The object of this test is to walk as FAR AS POSSIBLE for 6 minutes.

  5. Secondary 2C [ Time Frame: 3.5 years ]
    St. George's Respiratory Questionnaire: Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways

  6. Secondary 2D [ Time Frame: 3.5 years ]
    Dyspnea Score: it allows the patients to indicate the extent to which their breathlessness affects their mobility. The 1-5 stage scale is used alongside the questionnaire to establish clinical grades of breathlessness.



Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
40 participants age ≥ 12 and ≤70 years who experienced a documented case (documented by positive COVID19 test and/or clinical history) mild or severe COVID19 infection including those with symptoms and those who were hospitalized with COVID19 infection, all of whom are within 3 months post recovery.
Criteria

Inclusion Criteria:

  • Consent provided
  • Aged 12-70 years old
  • Meets MRI screening criteria
  • Diagnosed with COVID19, documented by positive COVID19 test (Nasopharyngeal swab or saliva swab) and are within 3 months post recovery*.

    • Recovery from COVID19 is defined as asymptomatic for at least 2 weeks prior to study visit 1 and screen negative based on SickKids guidelines.

Exclusion Criteria:

  • Pregnant or lactating*
  • A cold or flu within the last 2 weeks

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): NCT05014516


Contacts
Layout table for location contacts
Contact: giles Santyr, PhD 416-813-7654 ext 301394 giles.santyr@sickkids.ca
Contact: Sharon Braganza, MSc 4168137654 ext 307937 sharon.braganza@sickkids.ca

Locations
Layout table for location information
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Giles Santyr, PhD FCCPM       giles.santyr@sickkids.ca   
Contact: Sharon Braganza, M.Sc    416 813 7654 ext 307937    sharon.braganza@sickkids.ca   
Principal Investigator: Giles Santyr, PhD FCCPM         
Sponsors and Collaborators
The Hospital for Sick Children
Western University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Giles Santyr, Senior Scientist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT05014516    
Other Study ID Numbers: 1000074027
First Posted: August 20, 2021    Key Record Dates
Last Update Posted: September 22, 2022
Last Verified: September 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Giles Santyr, The Hospital for Sick Children:
Lung MRI
129Xenon
Additional relevant MeSH terms:
Layout table for MeSH terms
Infections
Communicable Diseases
COVID-19
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
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