{"doc_desc":{"title":"Descriptive, prognostic study of SARS-CoV-2 coronavirus infection in Martinique, conducted in a hospital cohort of patients with probable or confirmed COVID-19 infection","idno":"FRESH-PEF73828-en","producers":[{"name":"Valentine CAMPANA","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73828-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73828"},{"agency":"FReSH","code":"FRESH-PEF73828"}]},"title":"Descriptive, prognostic study of SARS-CoV-2 coronavirus infection in Martinique, conducted in a hospital cohort of patients with probable or confirmed COVID-19 infection","alternate_title":"EPIC"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Cyrille;CHABARTIER","PILabo":"CHU de Martinique","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA MARTINIQUE","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"137925573","role":"pi id"},{"title":"SIREN","uri":"200034528","role":"organisation id"},{"title":"RNSR","uri":"200820137H","role":"labo id"}],"email":"","isContact":"No"},{"type":"investigator","name":"Andr\u00e9;CABIE","PILabo":"Inserm\/Chu Martinique \/ CIC Antilles Guyane - Inserm 1424 - Maladies infectieuses, g\u00e9n\u00e9tiques et \u00e9mergentes en zone tropicale","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ORCID","uri":"0000-0003-0117-3061","role":"pi id"},{"title":"IdRef","uri":"08145094X","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"RNSR","uri":"200820137H","role":"labo id"}],"email":"andre.cabie@chu-martinique.fr","isContact":"Yes"}],"oth_id":[{"name":"Use of the database for projects around COVID-19: 2 projects in progress","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA MARTINIQUE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0376kfa34","role":"sponsor id"},{"title":"SIREN","uri":"200034528","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA MARTINIQUE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0376kfa34"},{"title":"SIREN","uri":"200034528"}]}]},"distribution_statement":{"contact":[{"name":"Andr\u00e9;CABIE","email":"andre.cabie@chu-martinique.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":"severe forms"},{"keyword":"demographic"},{"keyword":"virological"},{"keyword":"immunological"},{"keyword":"clinical"},{"keyword":"predictive factors"},{"keyword":"biological"}],"topics":[{"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":"Certain other viral diseases","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1136802325","title":"CIM-11"}]},{"topic":"COVID-19","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1730556128","title":"CIM-11"}]}],"purpose":"Identify the demographic, clinical, biological, virological and immunological factors associated with, or predictive of the onset of a severe form of COVID-19 in a cohort of children and adults managed in a hospital setting at Martinique University Hospital.","abstract":"","coll_dates":[{"start":"2020-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Martinique']","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\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Inclusion criterion: Patient hospitalised in a COVID-specific treatment unit, including intensive care, for possible or confirmed SARS-CoV-2 infection (PCR+ and\\\/or CT scan consistent with infection) at Martinique University Hospital. \",\n    \"clusion_E\": \"Refusal to take part, by the patient or their legal representativecriteria: patient with confirmed diagnosis of infection with a pathogen other than SARS-CoV-2, and no likelihood of co-infection with SARS-CoV-2\"\n}","data_kind":"['Clinical data','Biological data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality\r\nOthers"}]},"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.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"MeasurementsAndTests.Physical\",\"vocab\":\"CESSDA\"},\"value\":\"Physical\/biological measurements (blood pressure, weight, biochemistry, imaging, etc.)\"}","{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"< 500 individuals","response_rate":"Approximately 150 patients for the first wave, second wave ongoing"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"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":"18-11-2020","lastUpdatedAuto":null,"lastUpdatedManual":"07-05-2021","isContributorPI":"No","contributorName":"Andr\u00e9 CABIE","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA MARTINIQUE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Yes"},"collaborations":{"networkConsortium":"Yes"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"No","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Based on medical records","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"History, complications, daily clinical signs and symptoms from arrival in the emergency department up to D30, treatments, medical imaging, clinical events","biologicalDataDetails":"virological, bacteriological, haematological and biochemistry data obtained during the hospital stay","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}