An Open-label Observation Study to Assess the Potential Impact of Disease Modifying Therapies on COVID-19 Outcomes and the Antibody Response Following an Infection With SARS-CoV-2 in Patients With Multiple Sclerosis Within the Swiss Multiple Sclerosis Cohort.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,181
- 试验地点
- 7
- 主要终点
- Incidence of severe COVID-19 as defined by the WHO clinical progression scale (Score 6-9)
研究概览
简要总结
This nested project of the Swiss Multiple Sclerosis Cohort (SMSC) is to assess the severity of COVID-19 and the magnitude of antibody response after infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in patients already treated or not with various immunotherapies for multiple sclerosis followed in the framework of the SMSC.
详细描述
This nested project of the Swiss Multiple Sclerosis Cohort (SMSC) is to assess the severity of COVID-19 and the magnitude of antibody response after infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in patients already treated or not with various immunotherapies for multiple sclerosis followed in the framework of the SMSC.
To assess the frequency and severity of SARS-CoV-2 infections and associated symptoms in the study population, data is collected from systematic questioning during the SMSC-visits and from serum samples collected every 6-12 months within the SMSC (for measurement of anti-SARS-CoV-2 antibodies in pre-pandemic reference samples and prospectively to determine the anti-SARS-CoV-2-serostatus during the study period).
Combining the information on anti-SARS- CoV-2 serostatus and infection history opens the opportunity to determine the number of patients without or with only mild vs. moderate to severe COVID-19 symptoms in large groups of patients with Multiple Sclerosis (MS) treated with immunotherapies targeting various components of the immune system.
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
- •all patients in the Swiss Multiple Sclerosis Cohort (SMSC)
排除标准
- •Patients with Neuromyelitis optica and Radiologically Isolated Syndrome will be excluded
- •Existence of a documented refusal of further use of health-related personal data and/or biological material
结局指标
主要结局
Incidence of severe COVID-19 as defined by the WHO clinical progression scale (Score 6-9)
时间窗: through study completion, an average of 3 years
Incidence of severe COVID-19 as defined by the WHO clinical progression scale (Score 6-9). The WHO clinical progression scale provides a measure of illness severity across a range from 0 (not infected) to 10 (dead). Incidence of severe COVID-19 infections will be assessed by evaluation of collected data on confirmed SARS-CoV-2-infections and their clinical courses.
COVID-19 related death defined by the WHO clinical progression scale (Score 10)
时间窗: through study completion, an average of 3 years
COVID-19 related death defined by the WHO clinical progression scale (Score 10) in untreated and treated patients. The WHO clinical progression scale provides a measure of illness severity across a range from 0 (not infected) to 10 (dead).
次要结局
- Proportion of total confirmed SARS-CoV-2-infections (independent of WHO clinical progression scale Score).(through study completion, an average of 3 years)
- Change in mean titers of IgM- and IgG-antibodies against SARS-CoV-2(through study completion, an average of 3 years)
- Proportion of patients with Anti-SARS-CoV-2 seroconversion(through study completion, an average of 3 years)
- Change in individual titers of IgM- and IgG-antibodies against SARS-CoV-2(through study completion, an average of 3 years)