Assessment of the Response to the Complete Vaccination Guidelines Against Sars-cov2
NCT ID: NCT05153850
Last Updated: 2022-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
243 participants
OBSERVATIONAL
2022-01-01
2022-09-01
Brief Summary
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Detailed Description
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The 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.
The 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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Cases
Patients diagnosed with inflammatory bowel disease with the complete vaccination regimen.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of inflammatory bowel disease (Crohn's Disease or Ulcerative Colitis).
* 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.
* Treatment with biological therapy for at least 6 weeks prior to the time of vaccination for the group of patients treated with biological drugs.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
OTHER
Responsible Party
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Principal Investigators
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Federico Argüelles Arias
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Virgen Macarena
Locations
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Hospital Universitario Virgen Macarena
Seville, Andalusia, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FIS-COV-2021-01
Identifier Type: -
Identifier Source: org_study_id
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