CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
Hyperpolarized 129Xenon gasdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04828135
NCT04828135Phase 2Completed

Characterizing the Long-Term Cardiopulmonary Effects of COVID-19 With Hyperpolarized Xenon and Cardiac MRI

Bastiaan Driehuys·interventional·Posted Apr 1, 2021·Updated May 6, 2024

In Brief

A Phase 2 clinical trial evaluating Hyperpolarized 129Xenon gas for Covid19. Completed, enrolled 18 participants across 1 site.

Detailed Summary

The next phase of the COVID-19 pandemic is likely to see a surge in an associated chronic cardiopulmonary disease that will challenge health systems. Recovered patients are presenting with persistent dyspnea at the Duke Pulmonary Post-COVID clinic. Evidence is now mounting that recovered patients have significant residual pulmonary disease, while myocardial injury has also been increasingly reported. To optimally care for these patients, Duke Pulmonary study team must comprehensively assess and monitor the changes in cardiopulmonary function and relate the changes to physiologic and quality of life outcomes. The study team will deploy cutting-edge MRI to fully characterize cardiopulmonary function in enrolled 30 subjects (accrual 23 subjects) at time point 60-120 days post recovery and 6-9 months later. Cardiac MRI will assess the myocardial status and right ventricular function, while hyperpolarized 129Xe MRI will provide a 3D assessment of pulmonary ventilation, interstitial barrier integrity, and pulmonary vascular hemodynamics. The overall objective outlined in this study is to demonstrate the feasibility and value of comprehensive longitudinal imaging characterization of cardiopulmonary structure and function in patients recovered from Covid-19.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedApr 1, 2021
Enrollment StartMay 26, 2021
Primary CompletionApr 20, 2023
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 5.3 years ago

Interventions

Hyperpolarized 129Xenon gasdrug

Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),