Ignite Creation Date:
2025-12-24 @ 4:33 PM
Ignite Modification Date:
2025-12-25 @ 2:24 PM
Study NCT ID:
NCT04340466
Status:
COMPLETED
Last Update Posted:
2025-12-03
First Post:
2020-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
French Multicentre Observational Study on SARS-Cov-2 Infections (COVID-19) ICU Management Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1003}, 'targetDuration': '28 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2020-04-07', 'studyFirstSubmitQcDate': '2020-04-07', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality at day 28', 'timeFrame': 'day 28', 'description': 'Mortality at day 28'}], 'secondaryOutcomes': [{'measure': 'severe complications', 'timeFrame': 'up to day 28', 'description': 'severe complications (pulmonary embolism, acute kidney injury, myocarditis, cardiac arrest, liver failure, ventilator associated pneumonia) Yes / No'}, {'measure': 'Imaging', 'timeFrame': 'day 1', 'description': 'Delay in imaging in hours'}, {'measure': 'Delay in Microbiological diagnosis', 'timeFrame': 'day 1', 'description': 'delay in microbiological diagnosis in hours'}, {'measure': 'Antiviral therapy', 'timeFrame': 'up to day 28', 'description': 'Antiviral therapy Yes / no'}, {'measure': 'Antibiotic therapy', 'timeFrame': 'day 28', 'description': 'Antibiotic therapy Yes / No'}, {'measure': 'Covid-19 treatments', 'timeFrame': 'up to day 28', 'description': 'Covid-19 treatments Yes / No'}, {'measure': 'Patients receiving renal replacement therapy', 'timeFrame': 'up to day 28', 'description': 'number'}, {'measure': 'Patients receiving mechanical ventilation', 'timeFrame': 'up to day 28', 'description': 'number'}, {'measure': 'Vital status', 'timeFrame': 'day 28', 'description': 'Patient alive at day 28 : yes / No'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'SARS-Cov-2', 'Intensive Care Unit'], 'conditions': ['Pneumonia, Viral', 'Critically Ill', 'Corona Virus Infection']}, 'referencesModule': {'references': [{'pmid': '34256165', 'type': 'RESULT', 'citation': 'Roger C, Collange O, Mezzarobba M, Abou-Arab O, Teule L, Garnier M, Hoffmann C, Muller L, Lefrant JY, Guinot PG, Novy E, Abraham P, Clavier T, Bourenne J, Besch G, Favier L, Fiani M, Ouattara A, Joannes-Boyau O, Fischer MO, Leone M, Ait Tamlihat Y, Pottecher J, Cordier PY, Aussant P, Moussa MD, Hautin E, Bouex M, Julia JM, Cady J, Danguy Des Deserts M, Mayeur N, Mura T, Allaouchiche B; AZUREA group. French multicentre observational study on SARS-CoV-2 infections intensive care initial management: the FRENCH CORONA study. Anaesth Crit Care Pain Med. 2021 Aug;40(4):100931. doi: 10.1016/j.accpm.2021.100931. Epub 2021 Jul 10.'}]}, 'descriptionModule': {'briefSummary': 'Since December 2019, a new agent, the SARS-Cov-2 coronavirus has been rapidly spreading from China to other countries causing an international outbreak of respiratory illnesses named COVID-19. In France, the first cases have been reported at the end of January with more than 60000 cases reported since then. A significant proportion (20-30%) of hospitalized COVID-19 patients will be admitted to intensive care unit. However, few data are available for this special population in France.\n\nWe conduct a large observational cohort of ICU suspected or proven COVID-19 patients that will enable to describe the initial management of COVID 19 patients admitted to ICU and to identify factors correlated to clinical outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The target population of the study is all patients with suspected or proven SARS-Cov-2 infection (COVID-19)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to ICU for suspected or proven SARS-Cov-2 infection, defined by positive SARS-Cov-2 PCR or CT scan images\n* Patient \\> or= 18 years\n\nExclusion Criteria:\n\n* Patient study refusal\n* Patient already enrolled in the present study\n* Patient with respiratory illness with negative COVID-19 CT scan images and negative COVID\\_19 PCR'}, 'identificationModule': {'nctId': 'NCT04340466', 'acronym': 'FRENCH CORONA', 'briefTitle': 'French Multicentre Observational Study on SARS-Cov-2 Infections (COVID-19) ICU Management Study', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'French Multicentre Observational Study on SARS-Cov-2 Infections (COVID-19) ICU Management: the FRENCH CORONA Study', 'orgStudyIdInfo': {'id': '2020-A00797-32'}, 'secondaryIdInfos': [{'id': '2020-A00797-32', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Suspected or proven COVID-19 critically ill patients', 'interventionNames': ['Other: No intervention']}, {'label': 'Control', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Control', 'Suspected or proven COVID-19 critically ill patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'CLAIRE ROGER', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nīmes'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}