Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT04573868
Status:
UNKNOWN
Last Update Posted:
2020-10-05
First Post:
2020-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
National Study "AEC COVID-19"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '30 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-30', 'studyFirstSubmitDate': '2020-09-30', 'studyFirstSubmitQcDate': '2020-09-30', 'lastUpdatePostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '30 days', 'description': 'Patient who died after surgery 30 days after the surgical procedure'}], 'secondaryOutcomes': [{'measure': 'Morbidity', 'timeFrame': '30 days', 'description': 'Complictaions after surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID', 'Surgery'], 'conditions': ['Mortality']}, 'descriptionModule': {'briefSummary': 'Currently there is an important need to know the evolution, results and associated mortality of patients undergoing surgical intervention in Spain during the SARS-CoV-2 pandemic. With a national data collection, information could be obtained to guide the management of this group of complex patients operated on during the COVID-19 pandemic, with the aim of improving their treatment in the event of a second wave. The great spread of the virus and the difficulty in controlling it over time makes it a high priority for the scientific community in order to face new outbreaks.\n\nThe national study "AEC COVID-19" is a collaborative study (in the style of those carried out at European level such as Eurosurg, Globalsurg, etc.) that aims to know the evolution, results and associated mortality of patients undergoing surgical intervention in Spain during the SARS-CoV-2 pandemic. It is an observational study, with anonymized and coded data, which aims to demonstrate the following hypotheses:\n\n* Patients with COVID-19 have high mortality.\n* Patients with both oncological and benign pathologies have high morbidity.\n\nThe situation / follow-up at 7 days and 30 days after the intervention will be included in each patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients who undergo a surgical procedure during the pandemic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult patients who undergo a surgical procedure during the pandemic\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04573868', 'briefTitle': 'National Study "AEC COVID-19"', 'organization': {'class': 'OTHER', 'fullName': 'Hospitales Universitarios Virgen del Rocío'}, 'officialTitle': 'National Study "AEC COVID-19" on Patients Undergoing Surgical Intervention During the SARS-CoV-2 Pandemic.', 'orgStudyIdInfo': {'id': 'AEC-COVID'}}, 'contactsLocationsModule': {'locations': [{'zip': '41009', 'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Salvador Morales', 'role': 'CONTACT', 'email': 'smoralesc@gmail.com', 'phone': '+34646357875'}, {'name': 'Salvador Morales-Conde, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Isaias Alarcón, MD PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Salvador Morales-Conde', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'centralContacts': [{'name': 'Salvador Morales-Conde', 'role': 'CONTACT', 'email': 'smoralesc@gmail.com', 'phone': '670238582'}], 'overallOfficials': [{'name': 'Salvador Morales-Conde', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asociacion Española de Cirujanos'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospitales Universitarios Virgen del Rocío', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of the Unit of Innovation in Minimally Invesive Surgery. Associate Professor of Surgery', 'investigatorFullName': 'Salvador Morales Conde', 'investigatorAffiliation': 'Hospitales Universitarios Virgen del Rocío'}}}}