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The Effect of Covid-19 on the Disease Course of Multiple Sclerosis :Belgian Lessons Learned From Rocky I to Rocky IV (TofCoMS)

2022年6月3日 更新者:Marie D'hooghe

The Effect of Covid-19 on the Disease Course of Multiple Sclerosis

Retrospective observational cohort study. ToFCoMS: two years of follow-up of COVID-19 in MS.

研究概览

地位

完全的

条件

详细说明

Methods The Nationaal Multiple Sclerose Centrum (NMSC) Melsbroek is a large highly-specialized center specifically focusing on neurological management, multidisciplinary care and rehabilitation in patients with MS. Since March 2020 (i.e., the onset of the pandemic in Belgium, and the first of five waves of spiking infection numbers thus far in our country), clinical data of patients followed at the center have been collected in a local database in case of COVID-19 diagnosis. The following items have been recorded: name, gender and date of COVID-19 diagnosis; age, Expanded Disability Status Scale score, MS duration, clinical subtype and DMT regimen at time of COVID-19 diagnosis; COVID-19 severity (method 1: categorized as ambulatory, hospitalized, death; method 2: categorized as asymptomatic, mild illness, moderate illness, severe illness, critical illness and death); vaccination status (categorized as non-vaccinated, fully vaccinated, fully vaccinated + booster) at time of COVID-19 diagnosis. On February 28, 2022, this database was locked and consisted of 234180 unique individual COVID-19 cases.

The NMSC Melsbroek features a second and more large database containing a broad variety of (para)clinical information gathered during routine follow-up, which includes regular testing of general disability with the EDSS, leg function/ambulation with the Timed 25-Foot Walk Test (T25FWT), hand function/dexterity using the 9-Hole Peg Test (9HPT) and cognition/information processing speed with the Symbol Digit Modalities Test (SDMT). For each of these parameters, the first two assessments before COVID-19 diagnosis (labelled T0 and T1, respectively; T1 is the closest to COVID-19 diagnosis), and the first thereafter (labelled T2), were retrieved for each COVID-19 subject. If clinical measurements were performed during an in-house stay for rehabilitation purposes, only those performed on admission were retained (thus not necessarily those the closest to the COVID-19 infection).

研究类型

观察性的

注册 (实际的)

230

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Vlaams Brabant
      • Melsbroek、Vlaams Brabant、比利时、1820
        • Nationaal MS center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

MS patients with Covid 19 infection

描述

Inclusion Criteria:

diagnosis of Multiple Sclerosis Covid 19 infection with PCR test

Exclusion Criteria:

other diagnosis than Multiple Sclerosis

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:其他
  • 时间观点:追溯

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
The investigators hereby aim to answer the question whether COVID-19 affects the progression of clinical disability in MS
大体时间:2 years
The difference between the values measured at T-2 and T-1 (i.e., before COVID-19) will be compared, after adjustment for the time interval, with the difference between the respective values measured at T-1 and T1 (i.e., after COVID-19) for T25WT, 9HPT and SDMT. The investigators hereby aim to answer the question whether COVID-19 affects the progression of clinical disability in MS. Its effect on SDMT evolution has been defined as the primary endpoint of our study.
2 years

次要结果测量

结果测量
措施说明
大体时间
vaccination status and progression MS
大体时间:2 years
As secondary outcomes, the investigators want to explore whether (a) there is a relationship between COVID-19 severity and the evolution of clinical disability (i.e., differences between T-1 and T1), (b) vaccination status affects COVID-19 severity (in the total cohort as well as stratified according to DMT) and evolution of clinical disability (i.e., differences between T-1 and T1) and (c) DMT influences COVID-19 severity and evolution of clinical disability (i.e., differences between T-1 and T1).
2 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年3月1日

初级完成 (实际的)

2022年6月1日

研究完成 (实际的)

2022年6月1日

研究注册日期

首次提交

2022年6月2日

首先提交符合 QC 标准的

2022年6月2日

首次发布 (实际的)

2022年6月3日

研究记录更新

最后更新发布 (实际的)

2022年6月8日

上次提交的符合 QC 标准的更新

2022年6月3日

最后验证

2022年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

no IPD

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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