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 (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05153850

Collaborator

(none)

243

Enrollment

Location

Anticipated Duration (Months)

30.4

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
COVID-19

Detailed Description

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 Design

Study Type:

Observational

Anticipated Enrollment :

243 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Assessment of the Response to the Complete Vaccination Guidelines Against Sars-cov2 in Patients With Inflammatory Bowel Disease Under Inmunosuppressor Treatment

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Cases Patients diagnosed with inflammatory bowel disease with the complete vaccination regimen.

Outcome Measures

Primary Outcome Measures

Number of patients with peripheral blood antibodies against SARS-COV2. [Up to 16 weeks.]
Seroconversion rate against SARS-COV2 defined as the presence of antibodies in peripheral blood four months after the complete vaccination schedule against SARS-COV2.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Virgen Macarena	Sevilla	Andalucía	Spain	41009

Sponsors and Collaborators

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Investigators

Principal Investigator: Federico Argüelles Arias, Hospital Universitario Virgen Macarena

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

ClinicalTrials.gov Identifier:

NCT05153850

Other Study ID Numbers:

FIS-COV-2021-01

First Posted:

Dec 10, 2021

Last Update Posted:

Jan 3, 2022

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 3, 2022