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NCT05153850 | Not yet recruiting | COVID-19


Assessment of the Response to the Complete Vaccination Guidelines Against Sars-cov2
Sponsor:

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Brief Summary:

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.

Condition or disease

COVID-19

Detailed Description:

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. 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.

Study Type : Observational
Estimated Enrollment : 243 participants
Official Title: Assessment of the Response to the Complete Vaccination Guidelines Against Sars-cov2 in Patients With Inflammatory Bowel Disease Under Inmunosuppressor Treatment
Actual Study Start Date : January 1, 2022
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : September 1, 2022

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Criteria
Inclusion Criteria
  • Be of legal age (> 18 years).
  • 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
  • Last vaccination dose more than four months ago from the determination of antibodies against SARS-Cov2.

Assessment of the Response to the Complete Vaccination Guidelines Against Sars-cov2

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Assessment of the Response to the Complete Vaccination Guidelines Against Sars-cov2

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Locations


Not yet recruiting

Spain, Andalucía

Hospital Universitario Virgen Macarena

Sevilla, Andalucía, Spain, 41009

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