Assessment of the Response to the Complete Vaccination Gu... | NCT05153850

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

NCT05153850

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status

Unknown status

Last Update Posted

Jan 3, 2022Actual

Enrollment

243Estimated

Phase

Not provided

Conditions

COVID-19

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Estimated

Primary Completion Date

Jun 1, 2022Estimated

Completion Date

Sep 1, 2022Estimated

First Submitted Date

Dec 9, 2021

First Submission Date that Met QC Criteria

Dec 9, 2021

First Posted Date

Dec 10, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2021

Last Update Posted Date

Jan 3, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

243Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cases		Patients diagnosed with inflammatory bowel disease with the complete vaccination regimen.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Federico Argüelles Arias	Contact	955 00 80 00		farguelles@telefonica.net
Carlos García Pérez	Contact	955 04 31 27		administracion.eecc.hvm.sspa@juntadeandalucia.es

Overall Officials

Name	Affiliation	Role
Federico Argüelles Arias	Hospital Universitario Virgen Macarena	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitario Virgen Macarena		Seville	Andalusia	41009	Spain

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided