Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT04637867
Status:
COMPLETED
Last Update Posted:
2025-09-05
First Post:
2020-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
COVID-19 - Multicentre Study on Nosocomial Transmission of SARS-CoV-2 Virus: an Ancillary Study (NOSO-COR IMMUNO)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014777', 'term': 'Virus Diseases'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 189}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2020-11-16', 'studyFirstSubmitQcDate': '2020-11-19', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seroprevalence of SARS-CoV-2 antibodies in laboratory confirmed SARS-CoV-2 patients', 'timeFrame': 'Month 6', 'description': 'To describe the immune response to SARS-CoV-2 infection by measuring the level of IgG and IgM in the blood of patients six months after laboratory-confirmed diagnosis of SARS-CoV-2'}, {'measure': 'Seroprevalence of SARS-CoV-2 antibodies in laboratory confirmed SARS-CoV-2 patients', 'timeFrame': 'Month 12', 'description': 'To describe the immune response to SARS-CoV-2 infection by measuring the level of IgG and IgM in the blood of patients 12 months after laboratory-confirmed diagnosis of SARS-CoV-2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infection Viral']}, 'referencesModule': {'references': [{'pmid': '37681818', 'type': 'RESULT', 'citation': 'Khanafer N, Henaff L, Bennia S, Termoz A, Chapurlat R, Escuret V, Proriol M, Duvert F, Mena C, Planckaert C, Trehet-Mandez N, Saadatian-Elahi M, Vanhems P. Factors Associated with Long COVID-19 in a French Multicentric Prospective Cohort Study. Int J Environ Res Public Health. 2023 Aug 29;20(17):6678. doi: 10.3390/ijerph20176678.'}]}, 'descriptionModule': {'briefSummary': 'There are still uncertainties about the existence of protective immunity and the duration of protective antibodies in patients infected with SARS-CoV-2. Serological testing is an appropriate tool for epidemiological investigations to assess the persistence of antibodies over time. The nature of the immune response induced by this virus is also poorly understood. This ancillary study aims at assessing the immunological characteristics of patients that participated in the NOSO-COR study at Hospices Civils de Lyon six and twelve months after the initial infectious episode.\n\nTwo visits will be scheduled at 6 and 12 months (± 1 month) after the initial SARS-CoV-2 infectious episode, Blood, saliva and nasopharyngeal samples will be collected for seroprevalence and immunological investigation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSARS-CoV-2 confirmed by RT-PCR\n\n* Adults \\> 18 years\n* Signed consent form\n* Affiliated to the French health system\n\nExclusion Criteria:\n\n* Pregnant women\n* Hospitalized patients\n* Individuals subject to legal protection\n* Imprisoned individuals\n* Individuals who have expressed an opposition to participate, or who do not wish to donate blood samples'}, 'identificationModule': {'nctId': 'NCT04637867', 'briefTitle': 'COVID-19 - Multicentre Study on Nosocomial Transmission of SARS-CoV-2 Virus: an Ancillary Study (NOSO-COR IMMUNO)', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Multicentre Study on Nosocomial Transmission of SARS-CoV-2 Virus: an Ancillary Study', 'orgStudyIdInfo': {'id': '69HCL20_0761'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'RT-PCR confirmed COVID-19 patients', 'description': 'RT-PCR confirmed patients included in the NOSO-COR study are invited six and 12 months after the initial infection to provide blood (41.5mL in total), salivary and nasopharyngeal samples and to complete a questionnaire. Each visit is expected to take about one hour.', 'interventionNames': ['Other: Collection of blood, salivary and nasopharyngeal samples.']}], 'interventions': [{'name': 'Collection of blood, salivary and nasopharyngeal samples.', 'type': 'OTHER', 'description': 'Each visit M6 and M12\n\n* Blood: 1 PAXgene tube (2.5mL) 1 EDTA tube (4mL), 1 dry tube with gel (5mL), 3 EDTA tubes (10mL each)\n* Salivary sample\n* Nasopharyngeal sample', 'armGroupLabels': ['RT-PCR confirmed COVID-19 patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69003', 'city': 'Lyon', 'state': 'Rhone', 'country': 'France', 'facility': 'Service épidémiologie, Hopital édouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69003', 'city': 'Lyon', 'country': 'France', 'facility': 'hopital Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Philippe VANHEMS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lyon, France, 69003'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}