Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-30 @ 5:11 PM
Study NCT ID:
NCT04360733
Status:
UNKNOWN
Last Update Posted:
2021-05-05
First Post:
2020-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precision Immunology to Determine the Immune Response in Patients With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood including Serum and Immune cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-29', 'studyFirstSubmitDate': '2020-04-22', 'studyFirstSubmitQcDate': '2020-04-22', 'lastUpdatePostDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immune response', 'timeFrame': '4 weeks', 'description': 'Immune response of whole blood stimulation assay with various immune activators will be measured by FACS and multiplex Assay'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SARS-CoV 2', 'COVID']}, 'descriptionModule': {'briefSummary': 'To better understand the immune response to SARS-CoV-2 infection, we devised a precision immunology approach to systematically study the immune function of different patient cohorts'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with different severity of COVID-19. From asymptomatic to critical illness', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* SARS-Cov2 positive PCR\n\nExclusion Criteria:\n\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT04360733', 'briefTitle': 'Precision Immunology to Determine the Immune Response in Patients With COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'University of Bonn'}, 'officialTitle': 'Precision Immunology Approach to Better Understand the Divergent Host Responses Towards Infection With SARS-CoV-2', 'orgStudyIdInfo': {'id': 'BOST-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'asymptomatic Covid-19', 'description': 'Patients with confirmed SARS-CoV2 PCR but no clinical symptoms', 'interventionNames': ['Other: Blood draw']}, {'label': 'symptomatic Covid-19', 'description': 'Patients with confirmed SARS-CoV2 PCR and light clinical symptoms', 'interventionNames': ['Other: Blood draw']}, {'label': 'severe Covid-19', 'description': 'Patients with confirmed SARS-CoV2 PCR and severe clinical symptoms with ICU admission', 'interventionNames': ['Other: Blood draw']}, {'label': 'healthy controls', 'description': 'Persons with negative SARS-CoV2 PCR', 'interventionNames': ['Other: Blood draw']}], 'interventions': [{'name': 'Blood draw', 'type': 'OTHER', 'description': 'serial blood draw and subsequent deep immune phenotyping analysis, (ii.) immune activation assays, (iii.) transcriptome and (iv.) epigenome analysis in an overarching (v.) bioinformatics data analysis', 'armGroupLabels': ['asymptomatic Covid-19', 'healthy controls', 'severe Covid-19', 'symptomatic Covid-19']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53127', 'city': 'Bonn', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Chrisitan Bode, MD', 'role': 'CONTACT', 'email': 'christian.bode@ukb.uni-bonn.de', 'phone': '+4922828714119'}], 'facility': 'University Hospital Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}], 'centralContacts': [{'name': 'Christian Bode, MD', 'role': 'CONTACT', 'email': 'christian.bode@ukbonn.de', 'phone': '+49228287', 'phoneExt': '14119'}, {'name': 'Folkert Steinhagen, MD', 'role': 'CONTACT', 'email': 'Folkert.Steinhagen@ukbonn.de', 'phone': '+49228287', 'phoneExt': '14114'}], 'overallOfficials': [{'name': 'Eicke Latz, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institute of Innate Immunity, Univeristy of Bonn'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bonn', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Dr. Christian Bode', 'investigatorAffiliation': 'University of Bonn'}}}}