Covid19Phase 2NCT04828135
Dual MRI for Cardiopulmonary COVID-19 Long Haulers
A Phase 2 study testing Hyperpolarized 129Xenon gas in people with Covid19, run by Bastiaan Driehuys at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Hyperpolarized 129Xenon gas
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2021to 20 Apr 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Asthma, Allergy, and Airway Center
Durham, North Carolina, 27705
About this study
Official title: Characterizing the Long-Term Cardiopulmonary Effects of COVID-19 With Hyperpolarized Xenon and Cardiac MRI
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- Hyperpolarized 129Xenon gas
- Keywords
- MRI, Hyperpolarized 129Xe
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized 129Xenon gasDrug
Also called Xe MRI
Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),
| Study group | Role | What they receive |
|---|---|---|
| subjects with diagnosis of COVID-19 (Long-hauler) | Experimental | 23 subjects with a confirmed diagnosis of COVID-19 infection, and after 60 days or longer Receives: Drug: Hyperpolarized 129Xenon gas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Red Blood Cell to Membrane (RBC:M) Ratio
To determine cardiopulmonary structure-function abnormalities that characterize early phase COVID-19 recovery.
Measured: 1 year
Ventilation Defect Percent
To determine cardiopulmonary structure-function abnormalities that characterize early phase COVID-19 recovery.
Measured: 1 year
High Membrane Percent
To determine cardiopulmonary structure-function abnormalities that characterize early phase COVID-19 recovery.
Measured: 1 year
Red Blood Cell (RBC) Defect Percent
To determine cardiopulmonary structure-function abnormalities that characterize early phase COVID-19 recovery.
Measured: 1 year
Red Blood Cell to Membrane (RBC:M) Ratio at 9 Months
To characterize the evolution of cardiopulmonary abnormalities over 9 months.
Measured: 9 Months
Ventilation Defect Percent at 9 Months
To characterize the evolution of cardiopulmonary abnormalities over 9 months.
Measured: 9 months
High Membrane Percent at 9 Months
To characterize the evolution of cardiopulmonary abnormalities over 9 months.
Measured: 9 months
Red Blood Cell (RBC) Defect Percent at 9 Months
To characterize the evolution of cardiopulmonary abnormalities over 9 months.
Measured: 9 months
Identify MRI Features That Predict Physiological Outcomes With DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide)
DLCO is the extent to which oxygen passes from the air sacs of the lungs into the blood.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start26 May 2021
- Primary completion20 Apr 2023
- Study completion20 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bastiaan Driehuys
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bastiaan Driehuys, Duke University
- Investigators
- Loretta Que, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828135
- Sponsor's protocol ID
- Pro00107681
- Status last verified
- May 2024
- First submitted
- 11 Mar 2021
- Last updated
- 6 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing the Long-Term Cardiopulmonary Effects of COVID-19 With Hyperpolarized Xenon and Cardiac MRI
- ClinicalTrials.gov ID
- NCT04828135
- Acronym / sponsor ID
- Pro00107681
- Conditions
- Covid19
- Keywords
- MRI, Hyperpolarized 129Xe
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Bastiaan DriehuysUniversity, hospital or other
- Study start
- 26 May 2021 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Posted 6 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| subjects with diagnosis of COVID-19 (Long-hauler) | Experimental | Drug: Hyperpolarized 129Xenon gas23 subjects with a confirmed diagnosis of COVID-19 infection, and after 60 days or longer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperpolarized 129Xenon gasAlso: Xe MRIEach xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC), | Drug | subjects with diagnosis of COVID-19 (Long-hauler) |
Primary outcome
Red Blood Cell to Membrane (RBC:M) Ratio
Time frame: 1 year
To determine cardiopulmonary structure-function abnormalities that characterize early phase COVID-19 recovery.
Ventilation Defect Percent
Time frame: 1 year
To determine cardiopulmonary structure-function abnormalities that characterize early phase COVID-19 recovery.
High Membrane Percent
Time frame: 1 year
To determine cardiopulmonary structure-function abnormalities that characterize early phase COVID-19 recovery.
Red Blood Cell (RBC) Defect Percent
Time frame: 1 year
To determine cardiopulmonary structure-function abnormalities that characterize early phase COVID-19 recovery.
Red Blood Cell to Membrane (RBC:M) Ratio at 9 Months
Time frame: 9 Months
To characterize the evolution of cardiopulmonary abnormalities over 9 months.
Ventilation Defect Percent at 9 Months
Time frame: 9 months
To characterize the evolution of cardiopulmonary abnormalities over 9 months.
High Membrane Percent at 9 Months
Time frame: 9 months
To characterize the evolution of cardiopulmonary abnormalities over 9 months.
Red Blood Cell (RBC) Defect Percent at 9 Months
Time frame: 9 months
To characterize the evolution of cardiopulmonary abnormalities over 9 months.
Identify MRI Features That Predict Physiological Outcomes With DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide)
Time frame: Baseline
DLCO is the extent to which oxygen passes from the air sacs of the lungs into the blood.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loretta Que, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyperpolarized 129Xenon gas in people with Covid19, run by Bastiaan Driehuys at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Red Blood Cell to Membrane (RBC:M) Ratio (time frame: 1 year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.