Prospective Multicenter Cohort of Patients With Inflammatory Bowel Disease Treated by Infliximab or Vedolizumab During COVID-19 Pandemic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,109
- 试验地点
- 1
- 主要终点
- IgG and IgM anti SARS-CoV-2
研究概览
简要总结
Multicenter cohort of patients followed for 6 months during the pandemic in France with biocollection of sera and peripheral blood mononuclear cells
详细描述
Multicenter cohort of patients followed for 6 months during the pandemic in France with biocollection of sera and peripheral blood mononuclear cellsNo data has been published concerning the incidence and prevalence of SARS-CoV-2 infection in patients with IBD and treated by IV infusion of infliximab or vedolizumab. It seems that biotherapies have a minimal impact on the severity of the viral infection but data are scarce. The objectives of the cohort are to quantify the incidence and the prevalence of SARS-CoV-2 in this population of patients, to determine clinical, demographic and biological factors associated with the risk of infection and the severity of the disease with a Multicenter cohort of patients followed for 6 months during the pandemic in France with biocollection of sera and peripheral blood mononuclear cells.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients (>18 years), know Crohn's disease or ulcerative colitis, treated by infliximab or vedolizumab
排除标准
- •not affiliated to a sanitary social insurance
结局指标
主要结局
IgG and IgM anti SARS-CoV-2
时间窗: through study completion, an average of 2 year
Impact of antibodies du to immunosuppressive protocol on the risk of viral infection
次要结局
- demographic factors and severity of COVID-19 infection(through study completion, an average of 2 year)
- Clinical factors and severity of COVID-19 infection(through study completion, an average of 2 year)
- pharmacologic factors and severity of COVID-19 infection(through study completion, an average of 2 year)