{"study_desc":{"title_statement":{"idno":"FRESH-PEF73586-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73586"},{"agency":"FReSH","code":"FRESH-PEF73586"}]},"title":"Prognostic value of measuring the activation pathway for Triggering Receptor Expressed on Myeloid cells-1 (TREM-1) in patients hospitalised due to COVID-19","alternate_title":"COVITREM-1"},"study_authorization":{"agency":[{"name":"Other"}]},"authoring_entity":[{"name":"S\u00e9bastien;GIBOT","firstname":"S\u00e9bastien","lastname":"GIBOT","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/016ncsr12","role":"organisation id"},{"title":"SIREN","uri":"200042166","role":"organisation id"},{"uri":"091544122","role":"pi id","title":"IdRef"}],"email":"s.gibot@chru-nancy.fr","affiliationName":"CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE NANCY","PILabo":"Nancy Regional University Hospital","isContact":true}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE NANCY","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/016ncsr12","role":"sponsor id"},{"title":"SIREN","uri":"200042166","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"BPIFRANCE","extlink":[{"title":"SIREN","uri":"483790069"}]}]},"distribution_statement":{"contact":[{"name":"S\u00e9bastien;GIBOT","lastname":"GIBOT","firstname":"S\u00e9bastien","type":"contact","email":"s.gibot@chru-nancy.fr","affiliationName":"CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE NANCY","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/016ncsr12","role":"organisation id","title":"ROR"},{"uri":"200042166","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"biomarker"},{"keyword":"COVID-19"}],"topics":[{"topic":"Anaesthesiology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/e92e8adc-8256-4a4c-a052-b3cad420db7d"},{"title":"MeSH","uri":"D000776"}]},{"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":"Respiratory failure, unspecified as acute or chronic","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1609027855","title":"CIM-11"}]},{"topic":"COVID-19","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1730556128","title":"CIM-11"}]}],"purpose":"Evaluate the prognostic value of initial TREM-1 activation (first measurement collected) on clinical deterioration in patients hospitalised due to COVID-19 in medical, emergency and intensive care departments","abstract":"","coll_dates":[{"start":"2020-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","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\":\"Patients aged over 18\u00a0years Hospitalised for less than 3\u00a0days for any reason whatsoever, but screened for Covid-19. SARS-CoV-2 infection should be \\\"probable\\\" or \\\"confirmed\\\" according to the definition published on 3\u00a0April by Sant\u00e9 Publique France (French Public Health Agency): laboratory confirmation (by positive RT-PCR further to nasopharyngeal sample or any other sample and\/or positive serology indicating infection) or by a composite endpoint combining characteristic pulmonary impairment upon imaging and clinical\/laboratory effects suggesting viral infection (including: fever, cough, chest pain, and biological inflammatory syndrome, lymphopenia, elevated liver enzymes). Registered with a social security scheme or a beneficiary of such a scheme The patient or their representative will have received information on the study and signed the emergency informed consent\/inclusion form in compliance with Article L.1122-1-3 of the French Public Health Code (CSP)\",\"clusion_E\":\"\"}","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"}]},"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\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"1009"},"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\":[]}","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":"15-11-2020","lastUpdatedManual":"06-05-2021","isContributorPI":"","contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":true},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}