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

Lung Structure-Function In SurVivors of Mild and SEvere COVID-19 Infection: 129Xe MRI For Rapid Evaluation and NExt-wave Healthcare Planning

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.

Study Overview

• Status: Terminated
• Conditions: COVID-19 Respiratory Infection
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

• Study Contact: Name: Giles Santyr, PhD; Phone Number: 301394 416-813-7654; Email: giles.santyr@sickkids.ca
• Study Contact Backup: Name: Sharon Braganza, MSc; Phone Number: 307937 4168137654; Email: sharon.braganza@sickkids.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 70 years (Child, Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: Hyperpolarized tracer gas

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary 2A (i)	Pulmonary function test: Spirometry to measure FEV1 (L)	3.5 years
Secondary 2A (ii)	Pulmonary function test: Plethysmography/Lung volumes to measure TLC (L)	3.5 years
Secondary 2A (iii)	Pulmonary function test: Diffusing Capacity Of The Lungs For Carbon Monoxide to measure DLCO	3.5 years
Secondary 2B	6 minute walk test - The object of this test is to walk as FAR AS POSSIBLE for 6 minutes.	3.5years
Secondary 2C	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	3.5 years
Secondary 2D	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.	3.5 years

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: Western University

Publications and helpful links

General Publications

• Kooner HK, McIntosh MJ, Matheson AM, Venegas C, Radadia N, Ho T, Haider EA, Konyer NB, Santyr GE, Albert MS, Ouriadov A, Abdelrazek M, Kirby M, Dhaliwal I, Nicholson JM, Nair P, Svenningsen S, Parraga G. 129Xe MRI ventilation defects in ever-hospitalised and never-hospitalised people with post-acute COVID-19 syndrome. BMJ Open Respir Res. 2022 May;9(1):e001235. doi: 10.1136/bmjresp-2022-001235.

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2021
• Primary Completion (Actual): March 14, 2024
• Study Completion (Actual): March 14, 2024

Study Registration Dates

• First Submitted: July 30, 2021
• First Submitted That Met QC Criteria: August 18, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Lung MRI; 129Xenon
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Infections; Communicable Diseases; Respiratory Tract Infections; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Anesthetics, Inhalation; Xenon
• Other Study ID Numbers: 1000074027

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No