Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-25 @ 5:24 PM
Study NCT ID:
NCT04341103
Status:
UNKNOWN
Last Update Posted:
2020-04-10
First Post:
2020-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AlloSure Guided Immuno-Optimization for COVID-19: An Early Experience
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-08', 'studyFirstSubmitDate': '2020-03-16', 'studyFirstSubmitQcDate': '2020-04-08', 'lastUpdatePostDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessing the utility of AlloSure dd-cfDNA to guide clinical immune-optimization for transplant patients with COVID-19', 'timeFrame': '6 months', 'description': 'AlloSure dd-cfDNA blood draw values'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Organ Transplant Rejection', 'COVID-19']}, 'descriptionModule': {'briefSummary': 'The utilization of AlloSure to help guide immunosuppression management in solid organ transplant recipients diagnosed with COVID-19', 'detailedDescription': 'An observational case series of patients with solid organ transplants who have been admitted with suspected COVID-19 utilizing AlloSure dd-cf DNA to help guide immunosuppression management balancing the treatment of sepsis and avoiding allograft rejection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Solid organ (liver, heart, lung or kidney) transplant recipients diagnosed with suspected or confirmed case of COVID-19', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Liver, Heart, Lung or Kidney organ transplant recipient with a suspected or confirmed diagnosis of COVID-19\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT04341103', 'acronym': 'Al-COVE', 'briefTitle': 'AlloSure Guided Immuno-Optimization for COVID-19: An Early Experience', 'organization': {'class': 'INDUSTRY', 'fullName': 'CareDx'}, 'officialTitle': 'AlloSure Guided Immuno-Optimization for COVID-19: An Early Experience', 'orgStudyIdInfo': {'id': 'Al-COVE'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Alana Burns', 'role': 'CONTACT', 'email': 'aburns@caredx.com', 'phone': '415.287.2420'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CareDx', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}