{"study_desc":{"title_statement":{"idno":"FRESH-PEF73765-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73765"},{"agency":"FReSH","code":"FRESH-PEF73765"}]},"title":"Observational, prospective, multicentre cohort of patients followed up after hospitalisation to evaluate respiratory sequelae subsequent to SARS-CoV-2 (COVID-19) infection","alternate_title":"SISCOVID"},"study_authorization":{"agency":[{"name":"CPP"}]},"authoring_entity":[{"name":"George;CALCAIANU","firstname":"George","lastname":"CALCAIANU","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/054jcxz87","role":"organisation id"},{"title":"SIREN","uri":"200046985","role":"organisation id"},{"uri":"259330418","role":"pi id","title":"IdRef"}],"email":"george-daniel.calcaianu@ghrmsa.fr","affiliationName":"GROUPE HOSPITALIER DE LA REGION DE MULHOUSE ET SUD ALSACE (GHRMSA)","PILabo":"","isContact":true}],"oth_id":[{"name":"13 associated centers (CHR Orl\u00e9ans, CH Colmar, CHD La Roche Sur Yon, CH de la C\u00f4te Basque, CH Le Raincy Montfermeil, CH Douai, CHR Metz-Thionville, CH du Mans, CH Dunkerque, CH Soissons, CH Libourne, CH Annecy, CH Chamb\u00e9ry)","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"GROUPE HOSPITALIER DE LA REGION DE MULHOUSE ET SUD ALSACE (GHRMSA)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/054jcxz87","role":"sponsor id"},{"title":"SIREN","uri":"200046985","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":"George;CALCAIANU","lastname":"CALCAIANU","firstname":"George","type":"contact","email":"george-daniel.calcaianu@ghrmsa.fr","affiliationName":"GROUPE HOSPITALIER DE LA REGION DE MULHOUSE ET SUD ALSACE (GHRMSA)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/054jcxz87","role":"organisation id","title":"ROR"},{"uri":"200046985","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[],"topics":[{"topic":"Pulmonary medicine","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/f6e18c52-6087-4662-904c-5c4b8174e40e"},{"title":"MeSH","uri":"D015272"}]},{"topic":"Viral pneumonia","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1024154490","title":"CIM-11"}]},{"topic":"COVID-19","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1730556128","title":"CIM-11"}]}],"purpose":"Evaluate the respiratory sequelae after SARS-CoV-2 infection in patients hospitalised for severe COVID-19 pneumonia requiring O2, with subsequent outpatient follow-up (6 months) by: - Low-dose chest CT scan (LD-chest CT), - Static lung function tests (LFT), - Arterial blood gases in ambient air at rest (AA BG) and\/or with oxygen (O2 BG), - 6-minute walking test in ambient air (6WT AA) and\/or with oxygen (6WT O2)","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\":\"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\":\"Patient having received verbal information and not objecting to the study Age >= 18\u00a0years inclusive Patient hospitalised for severe COVID-19 pneumonia requiring O2 Patient having contracted SARS-CoV-2 infection proven by RT-PCR and\/or retrospective serology and\/or COVID-19 syndrome with chest CT scan consistent with infection (over the period from 1\u00a0March 2020 to 30\u00a0June 2020)\",\"clusion_E\":\"\"}","data_kind":"['Clinical data','Biological data']","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\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['']"}},"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":"< 500 individuals","response_rate":""},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational 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":"16-11-2020","lastUpdatedManual":"03-05-2021","isContributorPI":"","contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":true},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"","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":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}