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Hyperpolarized 129Xe MRI of Survivors of COVID-19

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ClinicalTrials.gov Identifier: NCT04659707
Recruitment Status : Recruiting
First Posted : December 9, 2020
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
Peter J. Niedbalski, PhD, University of Kansas Medical Center

Tracking Information
First Submitted Date  ICMJE December 7, 2020
First Posted Date  ICMJE December 9, 2020
Last Update Posted Date February 24, 2021
Actual Study Start Date  ICMJE February 22, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2020)
  • Ventilation Defect Percentage [ Time Frame: Baseline ]
    VDP at Baseline
  • Ventilation Defect Percentage [ Time Frame: 6-months ]
    VDP at 6 months
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hyperpolarized 129Xe MRI of Survivors of COVID-19
Official Title  ICMJE Evaluating Lung Structure and Function in Survivors of COVID-19 Using Hyperpolarized 129Xe MRI
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Covid19
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: COVID-19 Survivors
Subjects recovering from COVID-19 disease will be imaged using hyperpolarized 129Xe MRI.
Intervention: Drug: Hyperpolarized Xe129
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 7, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Peter J Niedbalski, PhD 9135882271 pniedbalski@kumc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04659707
Other Study ID Numbers  ICMJE 00146646
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Deidentified imaging data will be shared with researchers upon reasonable request.
Responsible Party Peter J. Niedbalski, PhD, University of Kansas Medical Center
Study Sponsor  ICMJE University of Kansas Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Kansas Medical Center
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP