COVID-19 and Multiple Sclerosis Disease Modifying Therapies
Prevalence of Coronavirus Disease 2019 in People With Multiple Sclerosis Taking Disease Modifying Therapies in England
The COVID-19 pandemic is a major concern for people on long-term treatments that modify the immune system function. People with multiple sclerosis (pwMS) form a large group who receive such treatments called disease modifying therapies (DMTs). Several types of DMTs with different effects on the immune system are being used for multiple sclerosis (MS). In the absence of large-scale national studies, the risk of COVID-19 among pwMS on various DMTs has not been established.
A few physician-reported registry-based studies have suggested that anti-CD20 monoclonal antibodies, such as ocrelizumab and rituximab, used in the treatment of MS can increase the risk of COVID-19. However, in our community-based COVID-19 study of a large cohort of pwMS as part of the UK MS Register, we could not demonstrate an association between DMTs and susceptibility to COVID-19. Other studies have not found any relationship between DMTs and the outcome of COVID-19 among pwMS.
To our knowledge, UK is the only country in the world that collects national data on DMT use, providing us with the opportunity to investigate the impact of DMTs on COVID-19 susceptibility and severity in a large population of pwMS. In England, no DMT is being dispensed without prior approval and specialised commissioning by the national Health Services (NHS) England & NHS Improvement (NHSE/I). The scheme, currently implemented in over 100 NHS Trusts in England, ensures that treatment decisions are made in line with agreed commissioning policy and are evidence-based. NHSE/I also has access to Public Health England (PHE) held data on all people who have had a SARS-CoV-2 test. By identifying all pwMS on DMTs and all those who have had a test for coronavirus and collecting data on the clinical outcome of their COVID-19 from their local NHS hospitals, we would be able to establish the risk of COVID-19 and the risk of contracting the infection associated with different DMTs. The findings of the study will help MS clinical teams address the concerns of pwMS about taking DMTs during the COVID-19 pandemic and update their guidelines on the measures pwMS need to take during these unprecedented times.
研究概览
研究类型
注册 (预期的)
联系人和位置
学习地点
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Nottinghamshire
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Nottingham、Nottinghamshire、英国、NG7 2UH
- Nottingham University Hospitals NHS Trust
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Age 18 or above
- Diagnosed with MS
- Received treatment with a DMT
Exclusion Criteria:
- Not fulfilling the inclusion criteria
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Tested positive for SARS-CoV-2
Eligible participants who have had a positive SARS-CoV-2 test will be included in the case group of the study.
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Not tested for SARS-CoV-2
A random sample of age, sex, and DMT matched people with MS who have not been tested for SARS-CoV-2 will be included in the control group of the study.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Prevalence of testing positive for SARS-CoV-2 in people with MS taking DMTs
大体时间:6 months
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The number of people with MS taking DMTs who have tested positive for SARS-CoV-2 among all people with MS taking DMTs in England.
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Clinical outcomes of COVID-19 among people with MS taking DMTs
大体时间:6 months
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To determine the clinical outcomes of COVID-19 (e.g., severity of disease, death, and recovery) in people with MS taking DMTs in England
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6 months
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Risk of contracting COVID-19 associated with individual DMTs/other clinical and paraclinical factors
大体时间:6 months
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To assess the risk of contracting COVID-19 associated with individual DMTs and other clinical (e.g., physical disability and comorbidities) and paraclinical (e.g., white blood cell and lymphocyte counts, vitamin D levels) factors among people with MS taking DMTs in England
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6 months
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Association between clinical outcomes of COVID-19 and individual DMTs/other clinical and paraclinical factors
大体时间:6 months
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To assess the association between clinical outcomes of COVID-19 and individual DMTs or other clinical (e.g., physical disability and comorbidities) and paraclinical (e.g., white blood cell and lymphocyte counts, vitamin D levels) factors among people with MS taking DMTs in England
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6 months
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合作者和调查者
调查人员
- 首席研究员:Nikos Evangelou, FRCP、Nottingham University Hospitals NHS Trust
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 20NS041
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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