NCT05014516

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

August 5, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 20, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2024

Completed
Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

2.6 years

First QC Date

July 30, 2021

Last Update Submit

July 29, 2025

Conditions

Keywords

Lung MRI129Xenon

Outcome Measures

Primary Outcomes (1)

  • 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 (6)

  • Secondary 2A (i)

    3.5 years

  • Secondary 2A (ii)

    3.5 years

  • Secondary 2A (iii)

    3.5 years

  • Secondary 2B

    3.5years

  • Secondary 2C

    3.5 years

  • +1 more secondary outcomes

Study Arms (1)

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

Observational

Also known as: Hyperpolarized tracer gas
Single arm

Eligibility Criteria

Age12 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (3)

  • 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.

  • Kooner HK, McIntosh MJ, Matheson AM, Abdelrazek M, Albert MS, Dhaliwal I, Kirby M, Ouriadov A, Santyr GE, Venegas C, Radadia N, Svenningsen S, Nicholson JM, Parraga G. Postacute COVID-19 Syndrome: 129Xe MRI Ventilation Defects and Respiratory Outcomes 1 Year Later. Radiology. 2023 Apr;307(2):e222557. doi: 10.1148/radiol.222557. Epub 2023 Feb 7.

  • 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 Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

July 30, 2021

First Posted

August 20, 2021

Study Start

August 5, 2021

Primary Completion

March 20, 2024

Study Completion

March 20, 2024

Last Updated

August 1, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations