Ignite Creation Date:
2025-12-26 @ 3:59 PM
Ignite Modification Date:
2025-12-29 @ 6:36 AM
Study NCT ID:
NCT04418206
Status:
COMPLETED
Last Update Posted:
2022-10-25
First Post:
2020-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validating an ELISpot for Early Detection of an Active Immune Response Against COVID-19
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'COVID-19 patients will be selected in the 4 participating centres Contact subjects and healthy volunteers will be selected only in the coordinating centre (Centre Hospitalier Universitaire de Nice)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 950}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-24', 'studyFirstSubmitDate': '2020-05-18', 'studyFirstSubmitQcDate': '2020-06-04', 'lastUpdatePostDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IgA specific cells of SARS', 'timeFrame': 'At 7 days', 'description': "Proportion of subjects with IgA-specific cells of SARS-CoV-2's Spike 1 protein at inclusion and 7 +/-2 days later"}], 'secondaryOutcomes': [{'measure': 'OMS progression scale', 'timeFrame': 'At 7 days', 'description': 'The scale is 7-point ordinal.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid 19']}, 'descriptionModule': {'briefSummary': 'The RT-PCR on rhino-pharynge sampling highlights the genetic material of the virus and indicates that a subject is infected with SARS-CoV-2. This test can be in about 30% of false negative cases, it does not allow to date the infection, nor to predict the asymptomatic, mild, moderate or severe evolution of the disease. In terms of public health, we need 1/ to better understand the chronology of the immune response to the virus in the general population and in contacts of index cases; 2/ To know which characteristics of the immune response are protective of future reinfections. Finally, in symptomatic subjects, we need biomarkers that predict the evolutionary mode of the disease (moderate vs. severe form).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age ≥ 18 years,\n* patients with confirmed SARS-Cov2 infection (RT PCR positive)\n* or patients suspected (evocative chest scanner)\n* OR patients exposure to SARS-CoV2 but no symptoms (patient's family, caregivers)\n* OR patients Non exposure to SARS-Cov2 volunteer subjects (general population)\n\nExclusion Criteria:\n\n* pregnant or breastfeeding female"}, 'identificationModule': {'nctId': 'NCT04418206', 'acronym': 'EliSpot', 'briefTitle': 'Validating an ELISpot for Early Detection of an Active Immune Response Against COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Validating an ELISpot for Early Detection of an Active Immune Response Against COVID-19', 'orgStudyIdInfo': {'id': '20-PP-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Samples With DNA', 'description': 'Nasopharyngal swab and blood samples', 'interventionNames': ['Other: patients COVID 19']}], 'interventions': [{'name': 'patients COVID 19', 'type': 'OTHER', 'description': "Exposure to SARS-Cov2 but no symptoms (patient's family, medical staff) and General population (volunteers not exposed to SARS-Cov2)", 'armGroupLabels': ['Samples With DNA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06606', 'city': 'Antibes', 'state': 'Alpes Maritimes', 'country': 'France', 'facility': 'CH Antibes', 'geoPoint': {'lat': 43.58127, 'lon': 7.12487}}, {'zip': '06414', 'city': 'Cannes', 'state': 'Alpes Maritimes', 'country': 'France', 'facility': 'Ch Cannes, Pneumologie', 'geoPoint': {'lat': 43.55135, 'lon': 7.01275}}, {'zip': '06355', 'city': 'Grasse', 'state': 'Alpes Maritimes', 'country': 'France', 'facility': 'Ch Grasse', 'geoPoint': {'lat': 43.65783, 'lon': 6.92537}}, {'zip': '06001', 'city': 'Nice', 'state': 'Alpes-Maritimes', 'country': 'France', 'facility': 'CHU de nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'LEROY Sylvie', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Nice, pneumologie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}