Lung Structure-Function In SurVivors of Mild and SEvere COVID-19 Infection: 129Xe MRI (LivCovidFree)
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|ClinicalTrials.gov Identifier: NCT05014516|
Recruitment Status : Recruiting
First Posted : August 20, 2021
Last Update Posted : September 22, 2022
|Condition or disease||Intervention/treatment|
|COVID-19 Respiratory Infection||Drug: 129Xenon gas|
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.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|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|
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
Other Name: Hyperpolarized tracer gas
- 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 2A (i) [ Time Frame: 3.5 years ]Pulmonary function test: Spirometry to measure FEV1 (L)
- Secondary 2A (ii) [ Time Frame: 3.5 years ]Pulmonary function test: Plethysmography/Lung volumes to measure TLC (L)
- Secondary 2A (iii) [ Time Frame: 3.5 years ]Pulmonary function test: Diffusing Capacity Of The Lungs For Carbon Monoxide to measure DLCO
- 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.
- 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
- 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.
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
|Contact: giles Santyr, PhD||416-813-7654 ext email@example.com|
|Contact: Sharon Braganza, MSc||4168137654 ext firstname.lastname@example.org|
|The Hospital for Sick Children||Recruiting|
|Toronto, Ontario, Canada, M5G 1X8|
|Contact: Giles Santyr, PhD FCCPM email@example.com|
|Contact: Sharon Braganza, M.Sc 416 813 7654 ext 307937 firstname.lastname@example.org|
|Principal Investigator: Giles Santyr, PhD FCCPM|