Ignite Creation Date:
2025-12-26 @ 3:59 PM
Ignite Modification Date:
2025-12-29 @ 6:42 AM
Study NCT ID:
NCT04426006
Status:
COMPLETED
Last Update Posted:
2025-09-03
First Post:
2020-06-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Serological Response to SARS-Cov-2 Virus in Personnel of the Institut Bergonié in the Context of the COVID-19 Pandemic
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'S.Mathoulin@bordeaux.unicancer.fr', 'phone': '0556333333', 'title': 'Pr Simone Mathoulin-Pelissier', 'organization': 'Institut Bergonié'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'As this study is an observational study, adverse events and serious adverse events were not collected.', 'eventGroups': [{'id': 'EG000', 'title': 'PRO-SERO-COV', 'description': 'Blood sample and self-administered questionnaire\n\nPRO-SERO-COV: At inclusion, 3 months and 12 months :\n\n* blood sample (2 x 5ml)\n* self-administered questionnaire', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at Inclusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '517', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRO-SERO-COV', 'description': 'Blood sample and self-administered questionnaire\n\nPRO-SERO-COV: At inclusion, 3 months and 12 months :\n\n* blood sample (2 x 5ml)\n* self-administered questionnaire'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Time 0 (Inclusion)', 'description': 'Total antibodies (IgG and IgM) directed against the N (nucleocapsid) protein of the virus were determined by ECLIA on a Cobas® 8000 (Roche Diagnostic, France) with the Elecsys Anti-SARS-CoV-2 kit.\n\nSerum was also tested by ELISA with the SARS-CoV-2 (IgG) ELISA Kit (EuroIm-mun, France).\n\nThese ELISA and ECLIA tests were carried out in the medical biology laboratory of the Institut Bergonié.\n\nSerological immune status to a previous infection by the SARS-CoV-2 virus was evaluated for each patient and defined as :\n\n* Positive in case of positive ELISA test AND/OR positive ECLIA test\n* Negative otherwise', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participant who completed the self-administered questionnaire and had blood sample available at inclusion'}, {'type': 'SECONDARY', 'title': 'Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRO-SERO-COV', 'description': 'Blood sample and self-administered questionnaire\n\nPRO-SERO-COV: At inclusion, 3 months and 12 months :\n\n* blood sample (2 x 5ml)\n* self-administered questionnaire'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'Total antibodies (IgG and IgM) directed against the N (nucleocapsid) protein of the virus were determined by ECLIA on a Cobas® 8000 (Roche Diagnostic, France) with the Elecsys Anti-SARS-CoV-2 kit.\n\nSerum was also tested by ELISA with the SARS-CoV-2 (IgG) ELISA Kit (EuroIm-mun, France).\n\nThese ELISA and ECLIA tests were carried out in the medical biology laboratory of the Institut Bergonié.\n\nSerological immune status to a previous infection by the SARS-CoV-2 virus was evaluated for each patient and defined as :\n\n* Positive in case of positive ELISA test AND/OR positive ECLIA test\n* Negative otherwise', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participant who completed the self-administered questionnaire and had blood sample available at inclusion and at 3 months'}, {'type': 'SECONDARY', 'title': 'Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRO-SERO-COV', 'description': 'Blood sample and self-administered questionnaire\n\nPRO-SERO-COV: At inclusion, 3 months and 12 months :\n\n* blood sample (2 x 5ml)\n* self-administered questionnaire'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Total antibodies (IgG and IgM) directed against the N (nucleocapsid) protein of the virus were determined by ECLIA on a Cobas® 8000 (Roche Diagnostic, France) with the Elecsys Anti-SARS-CoV-2 kit.\n\nECLIA test was carried out in the medical biology laboratory of the Institut Bergonié.\n\nSerological immune status to a previous infection by the SARS-CoV-2 virus was evaluated for each patients and defined as :\n\n* Positive in case of positive ECLIA test\n* Negative otherwise', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participant who completed the self-administered questionnaire and had blood sample available at inclusion, 3 months and 12 months'}, {'type': 'SECONDARY', 'title': 'Number of Health Care Workers With Active COVID-19 Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '517', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRO-SERO-COV', 'description': 'Blood sample and self-administered questionnaire\n\nPRO-SERO-COV: At inclusion, 3 months and 12 months :\n\n* blood sample (2 x 5ml)\n* self-administered questionnaire'}], 'classes': [{'title': '0 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '517', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Time 0 (inclusion), 3 months, 12 months', 'description': 'Defined by a positive result for the molecular test for the detection of the SARS-CoV-2 coronavirus genome by RT-PCR.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participant who completed the self-administered questionnaire and had blood sample available at inclusion (for 0 month visit) , 3 months (for 3 months visit) and 12 months (for 12 months visit)'}, {'type': 'SECONDARY', 'title': 'Number of Health Care Workers With Symptoms of Anxiety at 0 Months (Inclusion)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '460', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRO-SERO-COV (Optionnal Study)', 'description': 'Blood sample and self-administered questionnaire\n\nPRO-SERO-COV: At inclusion, 3 months and 12 months :\n\n* blood sample (2 x 5ml)\n* self-administered questionnaire\n\nInformed consent form signed for the optional study'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Time 0 (inclusion)', 'description': 'Generalized Anxiety Disorder (GAD-7) self-questionnaire, whose score varies from 0 (no anxiety) to 21 (severe anxiety).\n\nFollowing the recommended threshold, generalized anxiety is estimated from 10 points.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participant who completed the self-administered questionnaire and had blood sample available at inclusion and who signed informed consent form for the optional study and completed the GAD-7 at inclusion'}, {'type': 'SECONDARY', 'title': 'Number of Health Care Workers With Symptoms of Anxiety at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRO-SERO-COV (Optionnal Study)', 'description': 'Blood sample and self-administered questionnaire\n\nPRO-SERO-COV: At inclusion, 3 months and 12 months :\n\n* blood sample (2 x 5ml)\n* self-administered questionnaire\n\nInformed consent form signed for the optional study'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'Generalized Anxiety Disorder (GAD-7) self-questionnaire, whose score varies from 0 (no anxiety) to 21 (severe anxiety). Following the recommended threshold, generalized anxiety is estimated from 10 points.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participant who completed the self-administered questionnaire and had blood sample available at inclusion and who signed informed consent form for the optional study and completed the GAD-7 at 3 months'}, {'type': 'SECONDARY', 'title': 'Number of Health Care Workers With Symptoms of Anxiety at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRO-SERO-COV (Optionnal Study)', 'description': 'Blood sample and self-administered questionnaire\n\nPRO-SERO-COV: At inclusion, 3 months and 12 months :\n\n* blood sample (2 x 5ml)\n* self-administered questionnaire\n\nInformed consent form signed for the optional study'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Generalized Anxiety Disorder (GAD-7) self-questionnaire, whose score varies from 0 (no anxiety) to 21 (severe anxiety). Following the recommended threshold, generalized anxiety is estimated from 10 points.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participant who completed the self-administered questionnaire and had blood sample available at inclusion and who signed informed consent form for the optional study and completed the GAD-7 at 12 months'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PRO-SERO-COV', 'description': 'Blood sample and self-administered questionnaire\n\nPRO-SERO-COV: At inclusion, 3 months and 12 months :\n\n* blood sample (2 x 5ml)\n* self-administered questionnaire'}], 'periods': [{'title': 'Inclusion', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '526'}]}, {'type': 'COMPLETED', 'comment': 'Participants who completed the self-administered questionnaire and had blood sample at inclusion', 'achievements': [{'groupId': 'FG000', 'numSubjects': '517'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Self-administered questionnaire at inclusion not completed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Blood sample at inclusion not done', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': '3 Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '517'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '500'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}]}]}, {'title': '12 Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '500'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '462'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '38'}]}]}], 'recruitmentDetails': 'Inclusions from June 18th, 2020 to September 28th, 2020 in the Institut Bergonié (Bordeaux, France)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '517', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PRO-SERO-COV', 'description': 'Blood sample and self-administered questionnaire\n\nPRO-SERO-COV: At inclusion, 3 months and 12 months :\n\n* blood sample (2 x 5ml)\n* self-administered questionnaire'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '517', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '42.2', 'spread': '10.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '517', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '431', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '86', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-25', 'size': 557485, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-06-23T08:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 526}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2020-06-09', 'resultsFirstSubmitDate': '2022-06-24', 'studyFirstSubmitQcDate': '2020-06-09', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2023-04-13', 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at Inclusion', 'timeFrame': 'Time 0 (Inclusion)', 'description': 'Total antibodies (IgG and IgM) directed against the N (nucleocapsid) protein of the virus were determined by ECLIA on a Cobas® 8000 (Roche Diagnostic, France) with the Elecsys Anti-SARS-CoV-2 kit.\n\nSerum was also tested by ELISA with the SARS-CoV-2 (IgG) ELISA Kit (EuroIm-mun, France).\n\nThese ELISA and ECLIA tests were carried out in the medical biology laboratory of the Institut Bergonié.\n\nSerological immune status to a previous infection by the SARS-CoV-2 virus was evaluated for each patient and defined as :\n\n* Positive in case of positive ELISA test AND/OR positive ECLIA test\n* Negative otherwise'}], 'secondaryOutcomes': [{'measure': 'Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at 3 Months', 'timeFrame': '3 months', 'description': 'Total antibodies (IgG and IgM) directed against the N (nucleocapsid) protein of the virus were determined by ECLIA on a Cobas® 8000 (Roche Diagnostic, France) with the Elecsys Anti-SARS-CoV-2 kit.\n\nSerum was also tested by ELISA with the SARS-CoV-2 (IgG) ELISA Kit (EuroIm-mun, France).\n\nThese ELISA and ECLIA tests were carried out in the medical biology laboratory of the Institut Bergonié.\n\nSerological immune status to a previous infection by the SARS-CoV-2 virus was evaluated for each patient and defined as :\n\n* Positive in case of positive ELISA test AND/OR positive ECLIA test\n* Negative otherwise'}, {'measure': 'Rate of Positive Serological Immune Status to a Previous Infection by the SARS-CoV-2 Virus at 12 Months', 'timeFrame': '12 months', 'description': 'Total antibodies (IgG and IgM) directed against the N (nucleocapsid) protein of the virus were determined by ECLIA on a Cobas® 8000 (Roche Diagnostic, France) with the Elecsys Anti-SARS-CoV-2 kit.\n\nECLIA test was carried out in the medical biology laboratory of the Institut Bergonié.\n\nSerological immune status to a previous infection by the SARS-CoV-2 virus was evaluated for each patients and defined as :\n\n* Positive in case of positive ECLIA test\n* Negative otherwise'}, {'measure': 'Number of Health Care Workers With Active COVID-19 Infection', 'timeFrame': 'Time 0 (inclusion), 3 months, 12 months', 'description': 'Defined by a positive result for the molecular test for the detection of the SARS-CoV-2 coronavirus genome by RT-PCR.'}, {'measure': 'Number of Health Care Workers With Symptoms of Anxiety at 0 Months (Inclusion)', 'timeFrame': 'Time 0 (inclusion)', 'description': 'Generalized Anxiety Disorder (GAD-7) self-questionnaire, whose score varies from 0 (no anxiety) to 21 (severe anxiety).\n\nFollowing the recommended threshold, generalized anxiety is estimated from 10 points.'}, {'measure': 'Number of Health Care Workers With Symptoms of Anxiety at 3 Months', 'timeFrame': '3 months', 'description': 'Generalized Anxiety Disorder (GAD-7) self-questionnaire, whose score varies from 0 (no anxiety) to 21 (severe anxiety). Following the recommended threshold, generalized anxiety is estimated from 10 points.'}, {'measure': 'Number of Health Care Workers With Symptoms of Anxiety at 12 Months', 'timeFrame': '12 months', 'description': 'Generalized Anxiety Disorder (GAD-7) self-questionnaire, whose score varies from 0 (no anxiety) to 21 (severe anxiety). Following the recommended threshold, generalized anxiety is estimated from 10 points.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Health professionals', 'Serology', 'SARS-CoV-2 Antibodies', 'Anxiety', 'ELISA'], 'conditions': ['Sars-CoV2', 'Serum; Disease']}, 'referencesModule': {'references': [{'pmid': '37297553', 'type': 'BACKGROUND', 'citation': 'Richez B, Cantarel C, Durrieu F, Soubeyran I, Blanchi J, Pernot S, Chakiba Brugere C, Roubaud G, Cousin S, Etienne G, Floquet A, Babre F, Rivalan J, Lalet C, Narbonne M, Belaroussi Y, Bellera C, Mathoulin-Pelissier S. One-Year Follow-Up of Seroprevalence of SARS-CoV-2 Infection and Anxiety among Health Workers of a French Cancer Center: The PRO-SERO-COV Study. Int J Environ Res Public Health. 2023 May 25;20(11):5949. doi: 10.3390/ijerph20115949.'}]}, 'descriptionModule': {'briefSummary': 'The question of the immune response of the population, particularly of professional populations in contact with vulnerable populations (such as those with chronic conditions such as cancer), is an important issue. Knowing the evolution of this response over time in this population can help answer outstanding questions. The PRO-SERO-COV study is a seroprevalence study of caregivers working in the hospital sector with a follow-up at 3 months and 12 months. The objective is to evaluate and monitor at 3 and 12 months the serological immune status to an infection by the SARS-CoV-2 virus in active volunteer professionals working at the Institut Bergonié with different types of exposure: healthcare professionals and professionals in other services.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult 18 years-old and older.\n2. Person in employment (on fixed-term or permanent contracts) since (at least) March 17th, 2020, the date of national implementation of containment measures in response to the COVID-19 pandemic.\n3. Signed informed consent.\n4. Person affiliated to a French social security regimen in accordance with Article 1121-11 of the French Public Health Code).\n\nExclusion Criteria:\n\n1. Report of known active SARS-CoV-2 infection within 10 days prior to the date of signing the consent. Known active SARS-CoV-2 infection is defined as a positive result on a diagnostic RT-PCR test.\n2. Presence of known symptoms suggestive of COVID-19 within 10 days prior to the date of signing consent: fever, fatigue, dry cough, shortness of breath, loss of taste and/or smell, headache, body aches, aches and pains, conjunctivitis or colds, digestive disorders (vomiting, diarrhea).\n3. A person who is unable to follow and comply with research procedures due to geographical, social or psychological reasons.\n4. Pregnant or breastfeeding woman.\n5. Person deprived of their liberty, incapable or incapable of giving their consent.'}, 'identificationModule': {'nctId': 'NCT04426006', 'acronym': 'PRO-SERO-COV', 'briefTitle': 'Serological Response to SARS-Cov-2 Virus in Personnel of the Institut Bergonié in the Context of the COVID-19 Pandemic', 'organization': {'class': 'OTHER', 'fullName': 'Institut Bergonié'}, 'officialTitle': 'Serological Response to SARS-Cov-2 Virus in Personnel of the Institut Bergonié in the Context of the COVID-19 Pandemic - PRO-SERO-COV', 'orgStudyIdInfo': {'id': 'IB 2020-01'}, 'secondaryIdInfos': [{'id': '2020-A01355-34', 'type': 'OTHER', 'domain': 'ANSM ID-RCB number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'PRO-SERO-COV', 'description': 'Blood sample and self-administered questionnaire', 'interventionNames': ['Other: PRO-SERO-COV']}], 'interventions': [{'name': 'PRO-SERO-COV', 'type': 'OTHER', 'description': 'At inclusion, 3 months and 12 months :\n\n* blood sample (2 x 5ml)\n* self-administered questionnaire', 'armGroupLabels': ['PRO-SERO-COV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonié', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'overallOfficials': [{'name': 'Simone MATHOULIN-PELISSIER, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 's.mathoulin@bordeaux.unicancer.fr'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Bergonié', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}