Clinical Trials Logo
  1. Home
  2. Covid19
  3. NCT05153850
  4. Details
NCT05153850 Clinical Trial

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

COVID-19 Clinical Trial

— COVID-19  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05153850
Other study ID # FIS-COV-2021-01
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date September 1, 2022

Study information
Verified date December 2021
Source Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Contact Federico Argüelles Arias
Phone 955 00 80 00
Email farguelles@telefonica.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 243
Est. completion date September 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Spain Hospital Universitario Virgen Macarena Sevilla Andalucía

Sponsors (1)
Lead Sponsor Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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.
See also
  Status Clinical Trial Phase
Withdrawn NCT06065033 - Exercise Interventions in Post-acute Sequelae of Covid-19 N/A
Completed NCT06267534 - Mindfulness-based Mobile Applications Program N/A
Completed NCT05047601 - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection Phase 2/Phase 3
Recruiting NCT04481633 - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection N/A
Recruiting NCT05323760 - Functional Capacity in Patients Post Mild COVID-19 N/A
Completed NCT04612972 - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru Phase 3
Completed NCT04537949 - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults Phase 1/Phase 2
Recruiting NCT05494424 - Cognitive Rehabilitation in Post-COVID-19 Condition N/A
Active, not recruiting NCT06039449 - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2 Phase 3
Enrolling by invitation NCT05589376 - You and Me Healthy
Completed NCT05158816 - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting NCT04341506 - Non-contact ECG Sensor System for COVID19
Completed NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Completed NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Completed NCT05975060 - A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants. Phase 2/Phase 3
Active, not recruiting NCT05542862 - Booster Study of SpikoGen COVID-19 Vaccine Phase 3
Withdrawn NCT05621967 - Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation N/A
Terminated NCT05487040 - A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease Phase 1
Terminated NCT04498273 - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 Phase 3
Active, not recruiting NCT06033560 - The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure