{"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":[{"name":"Other"}]},"authoring_entity":[{"name":"Cyrille;CHABARTIER","firstname":"Cyrille","lastname":"CHABARTIER","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0376kfa34","role":"organisation id"},{"title":"SIREN","uri":"200034528","role":"organisation id"},{"uri":"137925573","role":"pi id","title":"IdRef"}],"email":"","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA MARTINIQUE","PILabo":"CHU de Martinique","isContact":false},{"name":"Andr\u00e9;CABIE","firstname":"Andr\u00e9","lastname":"CABIE","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"uri":"0000-0003-0117-3061","role":"pi id","title":"ORCID"},{"uri":"08145094X","role":"pi id","title":"IdRef"}],"email":"andre.cabie@chu-martinique.fr","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","PILabo":"Inserm\/Chu Martinique \/ CIC Antilles Guyane - Inserm 1424 - Maladies infectieuses, g\u00e9n\u00e9tiques et \u00e9mergentes en zone tropicale","isContact":true}],"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","lastname":"CABIE","firstname":"Andr\u00e9","type":"contact","email":"andre.cabie@chu-martinique.fr","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":"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":"{\"level_sex_clusion_I\":[{\"value\":\"Male\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008297\"}},{\"value\":\"Female\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D005260\"}}],\"level_age_clusion_I\":[{\"value\":\"Adolescent (13 to 18 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000293\"}},{\"value\":\"Young Adult (19 to 24 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D055815\"}},{\"value\":\"Adult (25 to 44 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000328\"}},{\"value\":\"Middle Aged (45 to 64 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008875\"}},{\"value\":\"Aged (65 to 79 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000368\"}},{\"value\":\"Aged, 80 and over (80 years and more)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000369\"}}],\"level_type_clusion_I\":\"Patients population\",\"level_type_clusion_other\":\"\",\"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. \",\"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\"}","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\"}]}","notes":""},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""}}},"additional":{"versionLang":"en","originLang":"en","autoTranslation":false,"status":"Imported","creationDate":"18-11-2020","lastUpdatedManual":"07-05-2021","isContributorPI":"","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":true},"collaborations":{"networkConsortium":true},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":false,"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":false},"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":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}