{"doc_desc":{"title":"Study of the incidence of SARS-CoV-2 infection in the Alpes-Maritimes administrative department based on the analysis of specific humoral and cellular response while easing lockdown restrictions","idno":"FRESH-PEF73574-en","producers":[{"name":"Jonathan ALLOUCHE","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE NICE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73574-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73574"},{"agency":"FReSH","code":"FRESH-PEF73574"}]},"title":"Study of the incidence of SARS-CoV-2 infection in the Alpes-Maritimes administrative department based on the analysis of specific humoral and cellular response while easing lockdown restrictions","alternate_title":"COVIMMUNE 2"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"K\u00e9vin;ZORZI","PILabo":"Recherche Clinique CHU de Nice","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE NICE","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"260600705","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"zorzi.k@chu-nice.fr","isContact":"Yes"}],"oth_id":[{"name":"Department of Public Health - Nice University Hospital","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE NICE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05qsjq305","role":"sponsor id"},{"title":"SIREN","uri":"260600705","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE NICE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05qsjq305"},{"title":"SIREN","uri":"260600705"}]},{"name":"DEPARTEMENT DES ALPES MARITIMES","extlink":[{"title":"SIREN","uri":"220600019"}]},{"name":"","extlink":[]}]},"distribution_statement":{"contact":[{"name":"Jonathan;ALLOUCHE","email":"allouche.j@chu-nice.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE NICE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05qsjq305","role":"organisation id","title":"ROR"},{"uri":"260600705","role":"organisation id","title":"SIREN"}]},{"name":"Christian;PRADIER","email":"pradier.c@chu-nice.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE NICE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05qsjq305","role":"organisation id","title":"ROR"},{"uri":"260600705","role":"organisation id","title":"SIREN"}]},{"name":"Barbara;SEITZ-POLSKI","email":"seitz-polski.b@chu-nice.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE NICE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05qsjq305","role":"organisation id","title":"ROR"},{"uri":"260600705","role":"organisation id","title":"SIREN"}]},{"name":"K\u00e9vin;ZORZI","email":"zorzi.k@chu-nice.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE NICE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05qsjq305","role":"organisation id","title":"ROR"},{"uri":"260600705","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"easing of lockdown restrictions"},{"keyword":"interferon"},{"keyword":"SARS-CoV-2 COVID-19 Serology"},{"keyword":"immunovirology"},{"keyword":"incidence"}],"topics":[{"topic":"Clinical immunology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/7a3cf568-46ba-4840-be8f-f22fc030139f"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D000486"}]},{"topic":"Infectious disease medicine","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D055552"}]},{"topic":"COVID-19","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1730556128","title":"CIM-11"}]},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"},{"topic":"Environmental determinants: Other","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Environmental determinants","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants: Employment","vocab":"health determinant"}],"purpose":"Determine the incidence of SARS-CoV-2 infection, over an 18-month period after the end of the first lockdown in a group of subjects whose professions involve contact with the general public. Determine the risk of re-infection after initial infection with SARS-CoV-2 confirmed by a positive serology test.","abstract":"","coll_dates":[{"start":"2020-01-01","end":"2022-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Provence - Alpes - C\u00f4te d\\'Azur']","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"General population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Any healthy adult volunteers, exposed to the general public from 11\u00a0May 2020, informed of the study via partner institutions (06 Administrative Department Council), registered with a social security scheme.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Socio-demographic data','Paraclinical data (non-biological) : Anthropometry']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Verification of electronic data entry. Database data management with consistency tests. Patients are informed of the use of their data.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nQuality of life\/health perception"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.) Population database for statistical purposes']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Self-administered questionnaire\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"","sources":[],"target_sample_size":"[500-1000[ individuals","response_rate":"Approximately 560"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"To be defined\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"15-11-2020","lastUpdatedAuto":null,"lastUpdatedManual":"01-10-2021","isContributorPI":"No","contributorName":"Jonathan ALLOUCHE","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE NICE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"D\u00e9tails de l'\u00e9tude sur Clinical Trial","link":"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04429594"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)","Public (France)"],"otherFundingAgentType":["","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Yes"},"collaborations":{"networkConsortium":"Yes"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Self-administered paper questionnaire, in-person interview, clinical examination and blood sample","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Alpes-Maritimes"},"dataTypes":{"clinicalDataDetails":"Clinical examination at inclusion","biologicalDataDetails":"Blood sample: Anti-SARS-CoV-2 IgA and IgG serology, QuantiFERON Monitor","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}