Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-01 @ 3:13 AM
Study NCT ID:
NCT05128656
Status:
WITHDRAWN
Last Update Posted:
2022-10-26
First Post:
2020-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Response of Asymptomatic EHPAD Employees Infected With 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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Case control longitudinal study, Interventional minimal risk study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Authorization denied by Ethical Comitee', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-24', 'studyFirstSubmitDate': '2020-11-19', 'studyFirstSubmitQcDate': '2021-11-19', 'lastUpdatePostDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of positive IgG serology', 'timeFrame': 'month 1-2 post infection', 'description': 'positive IgG (Immunoglobulin G) SARS-Cov-2 serology after infection of asymptomatic employees'}], 'secondaryOutcomes': [{'measure': 'rate of positive IgG serology', 'timeFrame': 'month 3-6 post infection', 'description': 'positive IgG (Immunoglobulin G) SARS-Cov-2 serology after infection of asymptomatic employees'}, {'measure': 'rate of positive immunoglobulin M (IgM) serology', 'timeFrame': 'month 1-2-3 and 6 post infection', 'description': 'positive IgM SARS-Cov-2 serology after infection of asymptomatic employees'}, {'measure': 'rate of neutralizing antibodies', 'timeFrame': 'month 1-2-3 and 6 post infection', 'description': 'concentration of neutralizing antibodies'}, {'measure': 'questionnaire', 'timeFrame': 'month 1-2-3 and 6 post infection', 'description': 'Associated factors with the presence of antibodies'}, {'measure': 're infection', 'timeFrame': 'through study completion, an average of 8 months', 'description': 'of asymptomatic patients with SARS-Cov-2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['EHPAD employees', 'COVID-19', 'asymptomatic', 'humoral response'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'The investigators performed in April 2020, a screening campaign of asymptomatic staff working in elderly nursing homes in Paris France (EHPAD), where the virus had been circulating actively in March and April 2020. Among 241 employees tested in four nursing homes, 32 (13.2%) were asymptomatic carriers of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Cov-2).\n\nFew data are available concerning the humoral immune response of asymptomatic carriers, the elicitation and duration of neutralizing antibodies and the duration of protection.\n\nThe purpose of the study is to determine whether these asymptomatic persons develop a humoral immune response, whether this immune response is durable and whether it is protective against the risk of reinfection', 'detailedDescription': 'The investigators performed in April 2020, a screening campaign of asymptomatic staff working in elderly nursing homes in Paris, France, where the virus had been circulating actively in March and April 2020. Among 241 employees tested in four nursing homes, 32 (13.2%) were asymptomatic carriers of SARS-Cov-2.\n\nFew data are available concerning the humoral immune response of asymptomatic carriers, the elicitation and duration of neutralizing antibodies and the duration of protection.\n\nThe main objective of this study is to describe the SARS-Cov-2 asymptomatic employees with positive immunoglobulin G (igG) serology at month 1-2 post infection.\n\nSecondary objectives are\n\n* To describe the proportion of asymptomatic persons with SARS-Cov-2 antibodies month 3 and 6 post infection\n* To compare the proportion of persons with SARS-Cov-2 antibodies between asymptomatic and asymptomatic carriers at M1-2 post infection, M3 and M6 post infection\n* To determine the factors associated with the appearance of antibodies ( viral load, age, sex, previous history, habitus..)\n* To study the neutralizing capacities and immune-profiling of SARS-Cov-2 antibodies in vitro\n* To evaluate the occurrence of Coronavirus Disease 2019 (COVID-19) reinfections in asymptomatic carriers during the second wave.\n\nThe design will be a case control study between\n\n* Cases: SARS-Cov-2 asymptomatic nursing homes employees\n* Controls: cohort of patients with a symptomatic COVID-19, preferably recruited in nursing homes or in case of difficulties in the virology service of COCHIN Hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Common inclusion criteria:\n\n * Age ≥ 18.\n * Health care employees working in the EHPAD who consulted in the Hotel Dieu Hospital\n * Affiliated with a health insurance\n * Informed information and consent\n* Inclusion Criteria for Cases (asymptomatic COVID-19 patients) :\n\n * Health care workers screened SARS-Cov-2 positive for NASopharyngeal swaths during screening campaigns for EHPAD staff.\n * Having carried out a follow-up serology (M1 and M2) within the Hotel Dieu.\n * Having never developed symptoms of COVID-19 or have developed some symptoms undetected before screening: fever, transient fatigue, rhinorrhea, symptoms that may be mistaken for a common winter cold (no respiratory symptoms or prolonged fever)\n* Inclusion criteria for controls (symptomatic COVID-19 patients) :\n\n * Health care workers tested positive for polymerase chain reaction assay (PCR) SARS-Cov-2 during screening campaigns for EHPAD staff at the Hotel Dieu.\n * Having carried out a follow-up serology (M1 and M2) within the Hotel Dieu.\n\nCOVID-19 symptoms defined by:\n\n* At least two major signs of COVID-19 among: \\> fever, cough, chest tightness, bilateral pneumonia, anosmia, loss of taste.\n* or a major sign and three minor signs among: headache, severe fatigue, diarrhea, odynophagia, rhinorrhea, suggestive skin signs.\n\nIt is part of the database of the virology department of Cochin Hospital (in case of failure to recruit health care workers in the EHPADs).\n\n\\*Exclusion criteria :\n\n* Refuse to participate or inability to obtain informed consent.\n* under guardianship, curators\n* negative SARS-COV-2 PCR\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05128656', 'acronym': 'SERASYMPTO', 'briefTitle': 'Immune Response of Asymptomatic EHPAD Employees Infected With COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Kinetic of Humoral Immune Response of Asymptomatic Nursing Homes (EHPAD) Employees Infected With Severe Acute Respiratory Syndrome Coronavirus : a Case Control Study', 'orgStudyIdInfo': {'id': 'APHP201253'}, 'secondaryIdInfos': [{'id': '2020-A01833-36', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cases', 'description': 'SARS-Cov-2 asymptomatic nursing homes employees', 'interventionNames': ['Other: serology']}, {'type': 'OTHER', 'label': 'Controls', 'description': 'cohort of patients with a symptomatic COVID-19, preferably recruited in nursing homes or in case of difficulties in the virology service of COCHIN Hospital.', 'interventionNames': ['Other: serology']}], 'interventions': [{'name': 'serology', 'type': 'OTHER', 'description': 'serology at M3 and serology at M6', 'armGroupLabels': ['Cases', 'Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75004', 'city': 'Paris', 'country': 'France', 'facility': 'HOTEL DIEU Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Dominique Salmon, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut Pasteur', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}