Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-27 @ 2:05 PM
Study NCT ID:
NCT05153850
Status:
UNKNOWN
Last Update Posted:
2022-01-03
First Post:
2021-12-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Response to the Complete Vaccination Guidelines Against Sars-cov2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], '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': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 243}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-13', 'studyFirstSubmitDate': '2021-12-09', 'studyFirstSubmitQcDate': '2021-12-09', 'lastUpdatePostDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with peripheral blood antibodies against SARS-COV2.', 'timeFrame': 'Up to 16 weeks.', 'description': 'Seroconversion rate against SARS-COV2 defined as the presence of antibodies in peripheral blood four months after the complete vaccination schedule against SARS-COV2.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'Prospective observational single-center study in which the impact of anti-TNF biological treatment on the humoral response after complete vaccination against SARS-COV2 in patients with inflammatory bowel disease is analyzed.', 'detailedDescription': 'Prospective observational single-center study in which the impact of anti-TNF biological treatment on the humoral response after complete vaccination against SARS-COV2 in patients with inflammatory bowel disease is analyzed.\n\nThe first objective is to compare the seroconversion rate after full vaccination against SARS-COV2 in patients with IBD treated with anti-TNF drugs versus patients treated with Ustekinumab / Vedolizumab and patients without immunosuppressive treatment.\n\nThe Patients included in the study belong to the health area of the Virgen Macarena University Hospital who meet the following inclusion criteria and none for exclusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The patients included in the study are elderly patients suffering from inflammatory bowel disease and have completed their vaccination schedule against the SARS-COV-2 virus.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Be of legal age (\\> 18 years).\n* Diagnosis of inflammatory bowel disease (Crohn's Disease or Ulcerative Colitis).\n* Complete vaccination schedule (one or two doses depending on previous SARS-Cov2 infection) between one and four months prior to the determination of anti-SARS-Cov2 antibodies.\n* Treatment with biological therapy for at least 6 weeks prior to the time of vaccination for the group of patients treated with biological drugs.\n\nExclusion Criteria:\n\n* Last vaccination dose more than four months ago from the determination of antibodies against SARS-Cov2."}, 'identificationModule': {'nctId': 'NCT05153850', 'acronym': 'COVID-19', 'briefTitle': 'Assessment of the Response to the Complete Vaccination Guidelines Against Sars-cov2', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Pública Andaluza para la gestión de la Investigación en Sevilla'}, 'officialTitle': 'Assessment of the Response to the Complete Vaccination Guidelines Against Sars-cov2 in Patients With Inflammatory Bowel Disease Under Inmunosuppressor Treatment', 'orgStudyIdInfo': {'id': 'FIS-COV-2021-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'Patients diagnosed with inflammatory bowel disease with the complete vaccination regimen.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '41009', 'city': 'Seville', 'state': 'Andalusia', 'country': 'Spain', 'contacts': [{'name': 'Federico Argüelles Arias', 'role': 'CONTACT', 'email': 'farguelles@telefonica.net', 'phone': '955 00 80 00'}, {'name': 'Carlos García Pérez', 'role': 'CONTACT', 'email': 'administracion.eecc.hvm.sspa@juntadeandalucia.es', 'phone': '955 04 31 27'}], 'facility': 'Hospital Universitario Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'centralContacts': [{'name': 'Federico Argüelles Arias', 'role': 'CONTACT', 'email': 'farguelles@telefonica.net', 'phone': '955 00 80 00'}, {'name': 'Carlos García Pérez', 'role': 'CONTACT', 'email': 'administracion.eecc.hvm.sspa@juntadeandalucia.es', 'phone': '955 04 31 27'}], 'overallOfficials': [{'name': 'Federico Argüelles Arias', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Virgen Macarena'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Pública Andaluza para la gestión de la Investigación en Sevilla', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}