Hyperpolarized 129Xe MRI of Survivors of COVID-19

• Sponsor: University of Kansas Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04659707
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 17.2
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate pulmonary function of patients recovering from mild, moderate, and severe COVID-19 disease using hyperpolarized 129Xe MRI.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Drug: Hyperpolarized Xe129	Phase 1

Detailed Description

COVID-19, the disease at the heart of the current global pandemic, is characterized by fevers, cough, sore throat, malaise, and myalgias, with 98% of patients experiencing some pulmonary involvement. In those infected with the causative virus, SARS-CoV-2, the severity of symptoms, as well as their duration, is widely variable. There is strong evidence from computed tomography (CT) images of patients with severe COVID-19 that pulmonary abnormalities and lung damage caused by infection may have long-term consequences for survivors. Furthermore, many patients with mild or moderate experience symptoms such as fatigue and dyspnea long (>60 days) after initial symptom onset, but there are currently no clinical predictors of which patients are at greatest risk for long-term health effects. As such, sensitive and specific predictors or biomarkers that can evaluate quality-of-life, risk of infection exacerbation, and long-term outcomes are critically needed.

Pulmonary imaging using hyperpolarized (HP) 129Xe magnetic resonance imaging (MRI) provides a means to detect abnormalities in the pulmonary small airways, vasculature, and parenchyma by quantifying pulmonary ventilation, gas diffusion, and regional gas exchange. HP 129Xe MRI is fast (<16s), non-invasive, and radiation free, making it a safe and effective method for characterizing lung function, even in individuals with lung disease. In this pilot study, we will use HP 129Xe to evaluate pulmonary structure and function in COVID-19 patients using the following specific aims:

Aim 1. Detect regional pulmonary function abnormalities in recovering COVID-19 patients using hyperpolarized 129Xe MRI. The hypothesis is that ventilation and gas exchange defects will be present in recovering COVID-19 patients, and further that the extent of impairment will correlate with disease severity.

Aim 2. Determine risk factors for long term outcomes using hyperpolarized 129Xe MRI and clinical biomarkers. The hypothesis is that HP 129Xe MRI biomarkers will predict long-term lung function impairment brought on by COVID-19.

These aims will be tested by performing HP 129Xe MRI in patients recovering from mild, moderate, or severe COVID-19. By coming to a fuller understanding of the long-term impairment of pulmonary function, future treatment can be optimized to minimize severe disease and health care utilization.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Evaluating Lung Structure and Function in Survivors of COVID-19 Using Hyperpolarized 129Xe MRI
• Actual Study Start Date: Feb 22, 2021
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: COVID-19 Survivors Subjects recovering from COVID-19 disease will be imaged using hyperpolarized 129Xe MRI.	Drug: Hyperpolarized Xe129; Subjects will inhale up to 4 doses of hyperpolarized Xenon gas in order to image pulmonary function.; Other Names: HP Xenon 129Xe

Outcome Measures

Primary Outcome Measures

1. Ventilation Defect Percentage [Baseline]

   VDP at Baseline

2. Ventilation Defect Percentage [6-months]

   VDP at 6 months

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Oxygenation saturation of ≥88% at rest by study staff within 48 hours prior to study entry.

• The participant has a previous diagnosis of COVID-19 confirmed by COVID-19 PCR or antibody testing and is being seen for outpatient follow-up.

• Subject is at least 10 days post-symptom-onset and do not have a fever (<99.5°).

• Ability to read and understand English or Spanish

Exclusion Criteria:

• Subject is less than 18 years old

• MRI is contraindicated based on responses to MRI screening questionnaire

• Subject is pregnant or lactating

• Subject does not fit into 129Xe vest coil used for MRI

• Subject cannot hold his/her breath for 15-16 seconds

• Subject deemed unlikely to be able to comply with instructions during imaging

• Oxygen saturation <88% on room air or with supplemental oxygen

• Cognitive deficits that preclude ability to provide consent

• Institutionalization

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Medical Center	Kansas City	Kansas	United States	66160

Sponsors and Collaborators

• University of Kansas Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peter J. Niedbalski, PhD, Research Assistant Professor, University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT04659707
• Other Study ID Numbers: 00146646
• First Posted: Dec 9, 2020
• Last Update Posted: Apr 4, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Apr 4, 2022