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临床试验/NCT04354519
NCT04354519已完成不适用

The UK MS Regsiter COVID-19 Substudy

Swansea University2 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2020年3月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,000
试验地点
2
主要终点
Mortality

研究概览

简要总结

The aim of the study is to understand the impact of COVID-19 on People with Multiple Sclerosis in the United Kingdom.

详细描述

Study objectives

  1. To identify the incidence of upper respiratory tract symptoms: fever, cough and breathing difficulties, other symptoms suggestive of COVID-19 infection, respiratory tract infections suggestive of COVID-19, and COVID-19 confirmed by laboratory testing among the UK MS population
  2. To establish if some DMDs increase the risk of COVID-19 infection
  3. To determine the incidence and effectiveness of self-isolation in the MS population. To examine the impact self-isolation has on mood, fatigue, and other routinely collected patient reported outcome measures from the MS Register.
  4. To determine the clinical outcome of respiratory tract infections, including confirmed and suspected cases of COVID-19, in terms of symptoms, time to recovery, hospital admission, requirement for ventilation, and death.
  5. To determine the longer-term impact of COVID-19 on MS, using routinely collected MS outcomes in the MS register, including impact on disability, relapses and changes in DMDs as assessed at 3 monthly intervals.
  6. To determine where people are obtaining their health information during the COVID-19 outbreak.
  7. To establish changes in DMDs prior to and as a result of symptoms related and unrelated to COVID-19

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

入选标准

  • >18 and confirmed diagnosis of MS, enrolled on UK MS Register

排除标准

  • None of the above

结局指标

主要结局

Mortality

时间窗: 1 Year from study commencement

Death data from routinely reported government level data (HES/PEDW)

Incidence of COVID-19 Infections within an MS Cohort in the UK

时间窗: Through study completion, an average of 1 year

Targeted questionnaire dependent on COVID Status

Hospitalisations in MS Patients with COVID-19

时间窗: 1 Year (regular outputs)

Monitor admission rates in linked population

次要结局

  • Patient Reported Expanded Disability Status Score(1 year (at least 6 monthly))
  • Hospital Anxiety and Depression Scale(1 year (at least 6 monthly))
  • Multiple Sclerosis Walking Scale 12 V2(1 year (at least 6 monthly))
  • Fatigue Severity Scale(1 year (at least 6 monthly))
  • EuroQol 5D (3l)(1 year (at least 6 monthly))
  • Multiple Sclerosis Impact Scale 29 V2(1 year (at least 6 monthly))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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