Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-01 @ 4:15 PM
Study NCT ID:
NCT04828135
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2021-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dual MRI for Cardiopulmonary COVID-19 Long Haulers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'loretta.que@duke.edu', 'phone': '919-681-8551', 'title': 'Loretta Que', 'organization': 'Duke University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '9 Months', 'description': 'Historical Controls were not monitored/assessed for deaths and/or adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Participants With Diagnosis of COVID-19 (Long-hauler)', 'description': 'Participants with a confirmed diagnosis of COVID-19 infection, and after 60 days or longer\n\nHyperpolarized 129Xenon gas: Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC)', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 1, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'Shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'notes': 'Adverse event is unknown; not related to the study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Red Blood Cell to Membrane (RBC:M) Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects With Diagnosis of COVID-19 (Long-hauler)', 'description': 'Participants with a confirmed diagnosis of COVID-19 infection, and after 60 days or longer\n\nHyperpolarized 129Xenon gas: Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),'}, {'id': 'OG001', 'title': 'Historical Controls', 'description': 'Participants with no diagnosis of COVID-19 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '0.39', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.51', 'spread': '0.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'To determine cardiopulmonary structure-function abnormalities that characterize early phase COVID-19 recovery.', 'unitOfMeasure': 'ratio (RBC:M)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Ventilation Defect Percent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects With Diagnosis of COVID-19 (Long-hauler)', 'description': 'Participants with a confirmed diagnosis of COVID-19 infection, and after 60 days or longer\n\nHyperpolarized 129Xenon gas: Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),'}, {'id': 'OG001', 'title': 'Historical Controls', 'description': 'Participants with no diagnosis of COVID-19 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'To determine cardiopulmonary structure-function abnormalities that characterize early phase COVID-19 recovery.', 'unitOfMeasure': 'percentage of ventilation defect', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'High Membrane Percent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects With Diagnosis of COVID-19 (Long-hauler)', 'description': 'Participants with a confirmed diagnosis of COVID-19 infection, and after 60 days or longer\n\nHyperpolarized 129Xenon gas: Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),'}, {'id': 'OG001', 'title': 'Historical Controls', 'description': 'Participants with no diagnosis of COVID-19 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '18.23', 'spread': '29.4', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'To determine cardiopulmonary structure-function abnormalities that characterize early phase COVID-19 recovery.', 'unitOfMeasure': 'percentage of high membrane', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Red Blood Cell (RBC) Defect Percent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects With Diagnosis of COVID-19 (Long-hauler)', 'description': 'Participants with a confirmed diagnosis of COVID-19 infection, and after 60 days or longer\n\nHyperpolarized 129Xenon gas: Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),'}, {'id': 'OG001', 'title': 'Historical Controls', 'description': 'Participants with no diagnosis of COVID-19 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '10.6', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '4.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'To determine cardiopulmonary structure-function abnormalities that characterize early phase COVID-19 recovery.', 'unitOfMeasure': 'percentage of RBC defect', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Red Blood Cell to Membrane (RBC:M) Ratio at 9 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects With Diagnosis of COVID-19 (Long-hauler)', 'description': 'Participants with a confirmed diagnosis of COVID-19 infection, and after 60 days or longer\n\nHyperpolarized 129Xenon gas: Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),'}], 'classes': [{'categories': [{'measurements': [{'value': '0.44', 'spread': '0.14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9 Months', 'description': 'To characterize the evolution of cardiopulmonary abnormalities over 9 months.', 'unitOfMeasure': 'ratio (RBC:M)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Ventilation Defect Percent at 9 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects With Diagnosis of COVID-19 (Long-hauler)', 'description': 'Participants with a confirmed diagnosis of COVID-19 infection, and after 60 days or longer\n\nHyperpolarized 129Xenon gas: Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '0.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9 months', 'description': 'To characterize the evolution of cardiopulmonary abnormalities over 9 months.', 'unitOfMeasure': 'percentage of ventilation defect', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'High Membrane Percent at 9 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects With Diagnosis of COVID-19 (Long-hauler)', 'description': 'Participants with a confirmed diagnosis of COVID-19 infection, and after 60 days or longer\n\nHyperpolarized 129Xenon gas: Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'spread': '30.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9 months', 'description': 'To characterize the evolution of cardiopulmonary abnormalities over 9 months.', 'unitOfMeasure': 'percentage of high membrane', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Red Blood Cell (RBC) Defect Percent at 9 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects With Diagnosis of COVID-19 (Long-hauler)', 'description': 'Participants with a confirmed diagnosis of COVID-19 infection, and after 60 days or longer\n\nHyperpolarized 129Xenon gas: Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '1.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9 months', 'description': 'To characterize the evolution of cardiopulmonary abnormalities over 9 months.', 'unitOfMeasure': 'percentage of RBC defect', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Identify MRI Features That Predict Physiological Outcomes With DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects With Diagnosis of COVID-19 (Long-hauler)', 'description': 'Participants with a confirmed diagnosis of COVID-19 infection, and after 60 days or longer\n\nHyperpolarized 129Xenon gas: Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'spread': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'DLCO is the extent to which oxygen passes from the air sacs of the lungs into the blood.', 'unitOfMeasure': 'percentage of predicted value', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants With Diagnosis of COVID-19 (Long-hauler)', 'description': 'Participants with a confirmed diagnosis of COVID-19 infection, and after 60 days or longer\n\nHyperpolarized 129Xenon gas: Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}], 'preAssignmentDetails': 'Historical Controls were not considered enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants With Diagnosis of COVID-19 (Long-hauler)', 'description': '23 participants with a confirmed diagnosis of COVID-19 infection, and after 60 days or longer\n\nHyperpolarized 129Xenon gas: Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),'}, {'id': 'BG001', 'title': 'Historical Controls', 'description': '10 participants with historical Hyperpolarized 129Xenon imaging'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-26', 'size': 591977, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-02-19T12:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-03', 'studyFirstSubmitDate': '2021-03-11', 'resultsFirstSubmitDate': '2024-03-26', 'studyFirstSubmitQcDate': '2021-03-30', 'lastUpdatePostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-03', 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Red Blood Cell to Membrane (RBC:M) Ratio', 'timeFrame': '1 year', 'description': 'To determine cardiopulmonary structure-function abnormalities that characterize early phase COVID-19 recovery.'}, {'measure': 'Ventilation Defect Percent', 'timeFrame': '1 year', 'description': 'To determine cardiopulmonary structure-function abnormalities that characterize early phase COVID-19 recovery.'}, {'measure': 'High Membrane Percent', 'timeFrame': '1 year', 'description': 'To determine cardiopulmonary structure-function abnormalities that characterize early phase COVID-19 recovery.'}, {'measure': 'Red Blood Cell (RBC) Defect Percent', 'timeFrame': '1 year', 'description': 'To determine cardiopulmonary structure-function abnormalities that characterize early phase COVID-19 recovery.'}, {'measure': 'Red Blood Cell to Membrane (RBC:M) Ratio at 9 Months', 'timeFrame': '9 Months', 'description': 'To characterize the evolution of cardiopulmonary abnormalities over 9 months.'}, {'measure': 'Ventilation Defect Percent at 9 Months', 'timeFrame': '9 months', 'description': 'To characterize the evolution of cardiopulmonary abnormalities over 9 months.'}, {'measure': 'High Membrane Percent at 9 Months', 'timeFrame': '9 months', 'description': 'To characterize the evolution of cardiopulmonary abnormalities over 9 months.'}, {'measure': 'Red Blood Cell (RBC) Defect Percent at 9 Months', 'timeFrame': '9 months', 'description': 'To characterize the evolution of cardiopulmonary abnormalities over 9 months.'}, {'measure': 'Identify MRI Features That Predict Physiological Outcomes With DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide)', 'timeFrame': 'Baseline', 'description': 'DLCO is the extent to which oxygen passes from the air sacs of the lungs into the blood.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MRI', 'Hyperpolarized 129Xe'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAlthough 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.\n\nExisting 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Diagnosis of post Coronavirus (COVID-19)\n\nInclusion Criteria:\n\n1. Age ≥ 18-year-old\n2. Tested positive for SARS-CoV2\n3. Willing and able to give informed consent and adhere to visit/protocol scheduled (consent must be given before any study procedures are performed)\n\nExclusion Criteria:\n\n1. Prisoners\n2. Pregnant, planning pregnancy, or lactating\n3. Conditions that prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine).\n4. 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"}, 'identificationModule': {'nctId': 'NCT04828135', 'briefTitle': 'Dual MRI for Cardiopulmonary COVID-19 Long Haulers', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Characterizing the Long-Term Cardiopulmonary Effects of COVID-19 With Hyperpolarized Xenon and Cardiac MRI', 'orgStudyIdInfo': {'id': 'Pro00107681'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'subjects with diagnosis of COVID-19 (Long-hauler)', 'description': '23 subjects with a confirmed diagnosis of COVID-19 infection, and after 60 days or longer', 'interventionNames': ['Drug: Hyperpolarized 129Xenon gas']}], 'interventions': [{'name': 'Hyperpolarized 129Xenon gas', 'type': 'DRUG', 'otherNames': ['Xe MRI'], 'description': 'Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),', 'armGroupLabels': ['subjects with diagnosis of COVID-19 (Long-hauler)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Asthma, Allergy, and Airway Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Loretta Que, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bastiaan Driehuys', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Radiology', 'investigatorFullName': 'Bastiaan Driehuys', 'investigatorAffiliation': 'Duke University'}}}}