Hyperpolarized 129Xe MRI of Survivors of COVID-19

NCT04659707 | Completed Phase 1 FDA Drug

• 1 other identifier: STUDY00146616
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (2)

• Ventilation Defect Percentage

  VDP at Baseline

  Baseline

• Ventilation Defect Percentage

  VDP at 6 months

  6-months

Study Arms (1)

COVID-19 Survivors

EXPERIMENTAL

Subjects recovering from COVID-19 disease will be imaged using hyperpolarized 129Xe MRI.

Drug: Hyperpolarized Xe129

Interventions

Hyperpolarized Xe129 DRUG

Subjects will inhale up to 4 doses of hyperpolarized Xenon gas in order to image pulmonary function.

Also known as: HP Xenon, 129Xe

COVID-19 Survivors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 9, 2020
• Study Start: February 22, 2021
• Primary Completion: January 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)