Lung Structure-Function In SurVivors of Mild and SEvere C... | NCT05014516

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

NCT05014516

Sponsor

The Hospital for Sick Children

Status

Terminated

Last Update Posted

Aug 1, 2025Actual

Enrollment

9Actual

Phase

Not provided

Conditions

COVID-19 Respiratory Infection

Interventions

129Xenon gas

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment Challenges

Expanded Access Info

Start Date

Aug 5, 2021Actual

Primary Completion Date

Mar 20, 2024Actual

Completion Date

Mar 20, 2024Actual

First Submitted Date

Jul 30, 2021

First Submission Date that Met QC Criteria

Aug 18, 2021

First Posted Date

Aug 20, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2025

Last Update Posted Date

Aug 1, 2025Actual

Name	Class
Western University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
129Xenon gas	Drug	Observational	Single arm	Hyperpolarized tracer gas

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Hospital for Sick Children		Toronto	Ontario	M5G 1X8	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39221567	Derived	Kooner HK, Wyszkiewicz PV, Matheson AM, McIntosh MJ, Abdelrazek M, Dhaliwal I, Nicholson JM, Kirby M, Svenningsen S, Parraga G. Chest CT Airway and Vascular Measurements in Females with COPD or Long-COVID. COPD. 2024 Dec;21(1):2394129. doi: 10.1080/15412555.2024.2394129. Epub 2024 Sep 2.
36749209	Derived