Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-01-01 @ 11:57 PM
Study NCT ID:
NCT04941092
Status:
COMPLETED
Last Update Posted:
2022-07-12
First Post:
2021-06-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of ARDS COVID-19 (WHO) vs ARDS Influenza in the ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D055371', 'term': 'Acute Lung Injury'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 157}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-08', 'studyFirstSubmitDate': '2021-06-24', 'studyFirstSubmitQcDate': '2021-06-24', 'lastUpdatePostDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality', 'timeFrame': 'at 28 days'}], 'secondaryOutcomes': [{'measure': 'length of stay in ICU', 'timeFrame': 'at 28 days'}, {'measure': 'length of mechanical ventilation', 'timeFrame': 'at 28 days'}, {'measure': 'length of vasopressors', 'timeFrame': 'at 28 days'}, {'measure': 'length of extrarenal epuration', 'timeFrame': 'at 28 days'}, {'measure': 'amount of drugs for sedation', 'timeFrame': 'at 28 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ards'], 'conditions': ['ARDS', 'COVID-19 Acute Respiratory Distress Syndrome', 'Influenza']}, 'descriptionModule': {'briefSummary': 'Since the beginning of the SARS CoV 2 pandemia, the SARS CoV 2 was frequently compared with the seasonal influenza virus. However, few studies compared patients presenting acute respiratory distress syndrome (ARDS) induced by these viruses, with results being discordant. Our study means to compare mortality and morbidity of patients hospitalized in an intensive care unit (ICU) with ARDS induced by SARS CoV-2 and seasonal influenza.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients hospitalized in Intensive Care Unit Hopital Central, Regional University Hospital of Nancy, France\n\n\\- hospitalized between 2009 and 2019 if influenza and in 2020 if SARS CoV 2', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients hospitalized in ICU\n* under mechanical ventilation\n* presenting an ARDS according to the Berlin definition\n* induced by either influenza or SARS CoV 2\n\nExclusion Criteria:\n\n* pregnant women\n* mechanical ventilation\\>48 hours before admission'}, 'identificationModule': {'nctId': 'NCT04941092', 'briefTitle': 'Comparison of ARDS COVID-19 (WHO) vs ARDS Influenza in the ICU', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Clinical Outcomes and Characteristics of Critically Ill Patients With Influenza and COVID-19 Induced ARDS: a Retrospective, Matched Cohort Study', 'orgStudyIdInfo': {'id': '2021PI076'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with ARDS induced by SARS CoV 2', 'interventionNames': ['Other: no intervention']}, {'label': 'patients with ARDS induced by influenza', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'no intervention, retrospective comparison', 'armGroupLabels': ['patients with ARDS induced by SARS CoV 2', 'patients with ARDS induced by influenza']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'country': 'France', 'facility': 'CHRU Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Lev VOLKOV', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}