Phase 2
N=18
Dual MRI for Cardiopulmonary COVID-19 Long Haulers
Covid19
Bottom Line
View on ClinicalTrials.gov: NCT04828135 ↗Enrolled (actual)
18
Serious AEs
16.7%
Results posted
May 2024
Primary outcome: Primary: Red Blood Cell to Membrane (RBC:M) Ratio — 0.39; 0.51 ratio (RBC:M)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Hyperpolarized 129Xenon gas (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bastiaan Driehuys
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Red Blood Cell to Membrane (RBC:M) Ratio |
0.39; 0.51 | — |
| PRIMARY Ventilation Defect Percent |
2.4; 0.6 | — |
| PRIMARY High Membrane Percent |
18.23; 0.5 | — |
| PRIMARY Red Blood Cell (RBC) Defect Percent |
10.6; 4.2 | — |
| PRIMARY Red Blood Cell to Membrane (RBC:M) Ratio at 9 Months |
0.44 | — |
| PRIMARY Ventilation Defect Percent at 9 Months |
0.5 | — |
| PRIMARY High Membrane Percent at 9 Months |
15 | — |
| PRIMARY Red Blood Cell (RBC) Defect Percent at 9 Months |
6.2 | — |
| PRIMARY Identify MRI Features That Predict Physiological Outcomes With DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide) |
20 | — |
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.
Eligibility Criteria
Diagnosis of post Coronavirus (COVID-19)
Inclusion Criteria
- Age ≥ 18-year-old
- Tested positive for SARS-CoV2
- Willing and able to give informed consent and adhere to visit/protocol scheduled (consent must be given before any study procedures are performed)
Exclusion Criteria
- Prisoners
- Pregnant, planning pregnancy, or lactating
- Conditions that prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine).
- Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements
Data sourced from ClinicalTrials.gov (NCT04828135). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.