{"doc_desc":{"title":"Immunopr\u00e9valence et immunoprotection contre SARS-CoV2 dans un \u00e9chantillon d'enfants hospitalis\u00e9es \u00e0 l'APHP et en Guyane et leurs parents","idno":"FRESH-PEF74038-fr","producers":[{"name":"Isabelle SERMET-GAUDELUS","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF74038-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"74038"},{"agency":"FReSH","code":"FRESH-PEF74038"}]},"title":"Immunopr\u00e9valence et immunoprotection contre SARS-CoV2 dans un \u00e9chantillon d'enfants hospitalis\u00e9es \u00e0 l'APHP et en Guyane et leurs parents","alternate_title":"PED-COVID"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Michaela;SEMERARO","PILabo":"Centre Investigation Clinique","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"18149714X","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"RNSR","uri":"199320123H","role":"labo id"}],"email":"michaela.semeraro@aphp.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"sponsor id"},{"title":"SIREN","uri":"267500452","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE LA RECHERCHE (ANR)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rbzpz17"},{"title":"SIREN","uri":"130002504"}]},{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14"},{"title":"SIREN","uri":"267500452"}]},{"name":"CAPNET","extlink":[{"title":"SIREN","uri":"403710536"}]}]},"distribution_statement":{"contact":[{"name":"Michaela;SEMERARO","email":"michaela.semeraro@aphp.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]},{"name":"Isabelle;SERMET-GAUDELUS","email":"isabelle.sermet@aphp.fr","type":"contact","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id","title":"ROR"},{"uri":"180036048","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"COVID enfant"},{"keyword":"m\u00e9m\u00e9oire immunitaire"},{"keyword":"transmission"}],"topics":[{"topic":"P\u00e9diatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D010372"}]},{"topic":"Pneumologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/f6e18c52-6087-4662-904c-5c4b8174e40e"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D015272"}]},{"topic":"COVID-19","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1730556128","title":"CIM-11"}]}],"purpose":"Etude de cohorte visant \u00e0 identifier l\u2019immunopr\u00e9valence et l\u2019immunoprotection des enfants ayant un m\u00e9decin r\u00e9f\u00e9rent \u00e0 l\u2019APHP (dans un centre recruteur) ou hospitalis\u00e9s depuis moins de 5 jours dans des sites p\u00e9diatriques de l\u2019APHP et un centre en Guyane et 1 de leurs parents. Etude longitudinale \u00b7 sur la sous-population des enfants et leurs parents positifs en PCR, quel que soit le pr\u00e9l\u00e8vement (cohorte principale) - 3 visites \u00e0 domicile ou \u00e0 l\u2019h\u00f4pital \u00e0 court terme (J 7, J15, J45 post d\u00e9but des sympt\u00f4mes ayant motiv\u00e9 l\u2019hospitalisation ou du pr\u00e9l\u00e8vement si enfant asymptomatique) visant \u00e0 \u00e9valuer la cin\u00e9tique de la r\u00e9ponse immunitaire et de la clairance virale - 2 visites \u00e0 long terme (6 mois et 1 an) visant \u00e0 \u00e9valuer la cin\u00e9tique du taux des Ac et l\u2019\u00e9valuation de la m\u00e9moire immunitaire. - D\u00e9pistage d\u2019\u00e9ventuelles r\u00e9infections par des pr\u00e9l\u00e8vements de salive si le patient pr\u00e9sente des sympt\u00f4mes compatibles avec une nouvelle infection COVID - en cas de r\u00e9infection authentifi\u00e9e par PCR salive + SARS-CoV2: - pr\u00e9l\u00e8vement sanguin (caract\u00e9risation de la r\u00e9ponse immunitaire humorale et cellulaire chez des patients pauci-symptomatiques) ; - pr\u00e9levements de selles, et nasopharynx si accord des parents (infection des diff\u00e9rents sites, viabilit\u00e9 du virus, mutations de SARS CoV2) ; \u00b7 Sur la sous population des enfants s\u00e9ropositifs ou fortement suspects d\u2019infections COVID rep\u00e9r\u00e9s lors de la 1ere vague : pr\u00e9l\u00e8vement \u00e0 la rentr\u00e9e 2020, soit environ 6 mois apr\u00e8s l\u2019infection (cohorte associ\u00e9e) Cohorte famille visant \u00e0 \u00e9valuer la transmission du virus de l\u2019enfant aux autres membres de la famille : 5 visites \u00e0 domicile post-d\u00e9pistage positif","abstract":"","coll_dates":[{"start":"2020-01-01","end":"2022-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Ile-de-France','Guyane']","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        },\n        {\n            \"value\": \"Autre\",\n            \"concept\": {\n                \"vocab\": [],\n                \"vocabURI\": []\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Nourrisson (28j \u00e0 2 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007223\"\n            }\n        },\n        {\n            \"value\": \"Petite enfance (2 \u00e0 5 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002675\"\n            }\n        },\n        {\n            \"value\": \"Enfance (6 \u00e0 12 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\n        {\n            \"value\": \"Adolescence (13 \u00e0 18 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000293\"\n            }\n        },\n        {\n            \"value\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Cohorte principale :  1) Enfants  -       tout enfant de plus de 7 jours et moins de 17 ans en consultation ou hospitalis\u00e9 depuis au plus 4 jours \u00e0 l\u2019AP-HP ou au CH Cayenne;  -       ou tout enfant de plus de 7 jours et moins de 17 ans, consid\u00e9r\u00e9 comme infect\u00e9 par SARS-CoV2 du fait d\u2019un test positif en PCR ou en test antig\u00e9nique , quel que soit le site -ces tests peuvent \u00eatre r\u00e9alis\u00e9s \u00e0 l\u2019APHP, ou au domicile, l\u2019enfant ayant un m\u00e9decin r\u00e9f\u00e9rent \u00e0 l\u2019AP-HP (dans un centre recruteur); quels que soient les sympt\u00f4mes ;  -       accord du parent pr\u00e9sent pour le pr\u00e9l\u00e8vement sanguin, salivaire et rectal  -       accord optionnel pour le pr\u00e9l\u00e8vement nasopharyng\u00e9  -       accord optionnel pour les pr\u00e9l\u00e8vements au domicile et au CIC ou \u00e0 l\u2019h\u00f4pital de r\u00e9f\u00e9rence si patient positif en qPCR  -       affiliation \u00e0 un r\u00e9gime de s\u00e9curit\u00e9 sociale.  2) adultes  \u00b7         un des parents de l\u2019enfant inclus dans la cohorte principale de l\u2019\u00e9tude PED-COVID  \u00b7         Donnant son accord pour pr\u00e9l\u00e8vement sanguin et salive  \u00b7         Accord optionnel pour pr\u00e9l\u00e8vement nasopharynx  \u00b7         accord optionnel pour les pr\u00e9l\u00e8vements au domicile et au CIC ou \u00e0 l\u2019h\u00f4pital de r\u00e9f\u00e9rence si sujet positif en qPCR  \u00b7         affiliation \u00e0 un r\u00e9gime de s\u00e9curit\u00e9 sociale.    Cohorte associ\u00e9e :  -        tout enfant de plus de 7 jours et moins de 17 ans; s\u00e9ropositif par la technique LIPS\\\/Pasteur  rep\u00e9r\u00e9 par la 1ere \u00e9tude lors de la 1ere vague, quel que soit le d\u00e9lai entre le diagnostic et l\u2019inclusion dans PED-COVID  OU  -       tout enfant de plus de 7 jours et moins de 17 ans; ayant pr\u00e9sent\u00e9 une atteinte clinique inflammatoire potentiellement reli\u00e9e \u00e0 SARS-CoV2, sur des arguments \u00e9pid\u00e9miologiques, cliniques, infectieux ou s\u00e9rologiques quel que soit le d\u00e9lai entre le diagnostic et l\u2019inclusion dans PED-COVID  -       affiliation \u00e0 un r\u00e9gime de s\u00e9curit\u00e9 sociale.     \u00b7         Cohorte famille  1)      Cas index  \u00b7      tout enfant de moins de 18 ans  \u00b7      scolaris\u00e9  \u00b7      consid\u00e9r\u00e9 comme infect\u00e9 par SARS-CoV2 du fait d\u2019un test positif en PCR ou en test antig\u00e9nique quel que soit le site accord du parent pr\u00e9sent pour le pr\u00e9l\u00e8vement sanguin et salivaire  \u00b7      accord optionel pour le pr\u00e9l\u00e8vement nasopharyng\u00e9affiliation \u00e0 un r\u00e9gime de s\u00e9curit\u00e9 sociale  2)      Autres membres vivants sous le m\u00eame toit  \u00b7      tout enfant, quel que soit son \u00e2ge ou adulte vivant sous le m\u00eame toit qu\u2019un enfant infect\u00e9  inclus dans PED-COVID-cohorte famille  \u00b7      affiliation \u00e0 un r\u00e9gime de s\u00e9curit\u00e9 sociale\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es paracliniques','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"","sources":[],"target_sample_size":"[500-1000[ individus","response_rate":"1000"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"A d\u00e9finir\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"----","lastUpdatedAuto":null,"lastUpdatedManual":"20-06-2025","isContributorPI":"Non","contributorName":"Isabelle SERMET-GAUDELUS","contributorAffiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Sermet et al. Eurosurveillance 2020","link":"http:\/\/epidemiologie-france.aviesan.fr"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)","Autre"],"otherFundingAgentType":["","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Oui"},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"CRF","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Ile de France et Guyane"},"dataTypes":{"clinicalDataDetails":"anamn\u00e9se","biologicalDataDetails":"s\u00e9rologie, etudes virales (PCR,ARN sous g\u00e9nomique, Charge virale, infection sur cellules v\u00e9ro; s\u00e9quences virales), m\u00e9moire immunitaire","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}