Clinical trial NCT04828135: Dual MRI for Cardiopulmonary COVID-19 Long Haulers
Official title: Characterizing the Long-Term Cardiopulmonary Effects of COVID-19 With Hyperpolarized Xenon and Cardiac MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Covid19
Keywords: MRI
Hyperpolarized 129Xe
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This will be a single-blinded open-label study enrolling 30 subjects (accrued 23 subjects (13 subjects who continue to have respiratory symptoms and 10 subjects within competitive sports) with a laboratory-confirmed diagnosis of COIVD-19 infection, and after 60 days or longer
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: The proposed research builds on the established sensitivity of Hyperpolarized 129Xe MRI to obstructive and pulmonary vascular lung disease, features expected to represented in the Covid-19 cohort. It further incorporates a new understanding of the possible role of myocardial injury in these recovered patients by combining cutting-edge pulmonary and cardiac MRI.

Although the initial presentation of patients with moderate to severe symptoms of COVID19 infections is dominated by respiratory symptoms, 10% go on to develop persistent post-infection symptoms which are thought to have an inflammatory etiology. Evidence suggests that pathologic activation of the inflammasome persists beyond the acute initial presentation that contributes to the persistent disabling symptoms characterized as "long-haul COVID". For this trial, subjects will be eligible for enrollment if subjects are outpatients with a history of a laboratory-confirmed diagnosis of COVID-19 infection, and after 60 days or longer. The study team will accrual 13 subjects who continue to have respiratory symptoms (i.e., cough, shortness of breath, dyspnea on exertion). An additional 10 subjects engaged in competitive sports and diagnosed with COVID-19 will also be enrolled. These subjects can be asymptomatic or mildly to moderately. Although rare, cardiac impairment has been documented in \<2% of these individuals. The study team knowledge, XeMRI has not yet been studied in this specific patient subset.

Existing data highlight significant racial and ethnic disparities with historically underserved minority populations (i.e., Black, LatinX) suffering disproportionately higher infection rates and more severe illness compared to Whites. This is reflected by the population enrolled in the study team RedCAP database and biorepository. As such 30% of subjects enrolled will be required to be from underserved communities.

Eligibility criteria: Diagnosis of post Coronavirus (COVID-19)

Inclusion Criteria:

1. Age ≥ 18-year-old
2. Tested positive for SARS-CoV2
3. 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:

1. Prisoners
2. Pregnant, planning pregnancy, or lactating
3. Conditions that prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine).
4. 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

Primary outcomes:
measure: Red Blood Cell to Membrane (RBC:M) Ratio
timeFrame: 1 year
measure: Ventilation Defect Percent
timeFrame: 1 year
measure: High Membrane Percent
timeFrame: 1 year
measure: Red Blood Cell (RBC) Defect Percent
timeFrame: 1 year
measure: Red Blood Cell to Membrane (RBC:M) Ratio at 9 Months
timeFrame: 9 Months
measure: Ventilation Defect Percent at 9 Months
timeFrame: 9 months
measure: High Membrane Percent at 9 Months
timeFrame: 9 months
measure: Red Blood Cell (RBC) Defect Percent at 9 Months
timeFrame: 9 months
measure: Identify MRI Features That Predict Physiological Outcomes With DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Asthma, Allergy, and Airway Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Loretta Que, MD
role: PRINCIPAL_INVESTIGATOR
References: