Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-31 @ 12:07 PM
Study NCT ID:
NCT05080933
Status:
COMPLETED
Last Update Posted:
2021-10-18
First Post:
2021-10-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ECMO for COVID-19 vs Influenza A H1N1 Associated ARDS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 308}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-15', 'studyFirstSubmitDate': '2021-10-15', 'studyFirstSubmitQcDate': '2021-10-15', 'lastUpdatePostDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All cause mortality on day 60 after ECMO initiation', 'timeFrame': '60 days'}], 'secondaryOutcomes': [{'measure': 'Hospital length of stay', 'timeFrame': '90 days'}, {'measure': 'ICU length of stay', 'timeFrame': '90 days'}, {'measure': 'Hospital mortality on day 90 after ECMO initiation', 'timeFrame': '90 days'}, {'measure': 'ECMO duration', 'timeFrame': '90 days'}, {'measure': 'ECMO associated hemorrhagic complications', 'timeFrame': '60 days'}, {'measure': 'ECMO associated mechanical complications', 'timeFrame': '60 days'}, {'measure': 'Invasive mechanical ventilation duration', 'timeFrame': '90 days'}, {'measure': 'ECMO related haemorrhagic complications', 'timeFrame': '90 days'}, {'measure': 'ECMO related mechanical complications', 'timeFrame': '90 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ARDS', 'COVID-19', 'H1N1 Influenza']}, 'referencesModule': {'references': [{'pmid': '35123562', 'type': 'DERIVED', 'citation': 'Fanelli V, Giani M, Grasselli G, Mojoli F, Martucci G, Grazioli L, Alessandri F, Mongodi S, Sales G, Montrucchio G, Pizzi C, Richiardi L, Lorini L, Arcadipane A, Pesenti A, Foti G, Patroniti N, Brazzi L, Ranieri V. Extracorporeal membrane oxygenation for COVID-19 and influenza H1N1 associated acute respiratory distress syndrome: a multicenter retrospective cohort study. Crit Care. 2022 Feb 5;26(1):34. doi: 10.1186/s13054-022-03906-4.'}]}, 'descriptionModule': {'briefSummary': 'Objective: Veno-venous ECMO has been used as a rescue therapy for patients with severe ARDS associated to influenza A H1N1 and COVID19 viral pneumonia. Little is known about outcome of these patients who required extracorporeal support.\n\nResearch question: To compare outcome of patients who required VV ECMO for Covid19 and H1N1 associated ARDS'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who required VV ECMO for COVID-19 and influenza A H1N1 associated ARDS', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COVID-19 or influenza A H1N1 (suspected or confirmed) diagnosis\n* Severe ARDS (according to Berlin Definition)\n* VV ECMO\n* Invasive mechanical ventilation through endotracheal tube or tracheostomy\n\nExclusion Criteria:\n\n• Age\\<18 years'}, 'identificationModule': {'nctId': 'NCT05080933', 'acronym': 'InfluCOV_ECMO', 'briefTitle': 'ECMO for COVID-19 vs Influenza A H1N1 Associated ARDS', 'organization': {'class': 'OTHER', 'fullName': 'University of Turin, Italy'}, 'officialTitle': 'Extracorporeal Membrane Oxygenation for COVID-19 and Influenza H1N1 Associated Acute Respiratory Distress Syndrome: a Multi-centre Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'v1_12_2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-19'}, {'label': 'H1N1'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10126', 'city': 'Turin', 'country': 'Italy', 'facility': 'University of Turin - Azienda Ospedaliera Città della Salute e della Scienza di Torino', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Turin, Italy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Vito Fanelli MD, PhD', 'investigatorAffiliation': 'University of Turin, Italy'}}}}