Assessment of the Response to the Complete Vaccination Guidelines Against Sars-cov2 in Patients With Inflammatory Bowel Disease Under Inmunosuppressor Treatment
试验速览
- 阶段
- 不适用
- 入组人数
- 243
- 试验地点
- 1
- 主要终点
- Number of patients with peripheral blood antibodies against SARS-COV2.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Last vaccination dose more than four months ago from the determination of antibodies against SARS-Cov2.
结局指标
主要结局
Number of patients with peripheral blood antibodies against SARS-COV2.
时间窗: 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.
次要结局
未报告次要终点