Impact of COVID 19 Vaccination or Infection on Disease Activity in Radiologically Isolated Syndrome Cohort: the VaxiRIS Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 217
- 试验地点
- 1
- 主要终点
- COVID 19 vaccination and clinical conversion to multiple sclerosis risk
研究概览
简要总结
The Radiologically Isolated Syndrome (RIS) is defined as incidental Magnetic Resonance Imaging (MRI) abnormalities fulfil the criteria for dissemination in space, suggestive of multiple sclerosis. Nowadays, mandatory vaccination in patients with multiple sclerosis (MS) is widely recommended. Regarding COVID19, the absence of specific warnings led to the proposal of vaccination in patients with inflammatory diseases of the central nervous system. We aimed to evaluate if COVID19 vaccination or infection increased the risk of clinical conversion to multiple sclerosis or evidence of disease activity (EDA) in a cohort of RIS subjects.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients belong to the RISC cohort;
- •totally vaccinated ou partially vaccinated patient
- •vaccination status known
排除标准
- •presented a first clinical event before the COVID19 vaccination
结局指标
主要结局
COVID 19 vaccination and clinical conversion to multiple sclerosis risk
时间窗: year 2
number of patients with a conversion to MS in each group
次要结局
- COVID 19 vaccination and evidence disease activity risk(year 2)
- multiple sclerosis evolution and history of COVID 19 infection(year 2)