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临床试验/NCT05033782
NCT05033782已完成不适用

Impact of the Modifications of Environmental Exposures and Health Care Access During COVID-19 Lockdown on the Risk of Multiple Sclerosis Clinical Relapse or Clinical Worsening

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 1,209 人开始时间: 2022年2月8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
1,209
试验地点
1
主要终点
Multiple Sclerosis Relapse

研究概览

简要总结

Multiple Sclerosis (MS) is a demyelinating auto immune disease of the central nervous system, affecting 2500000 people worldwide. Risk factors for MS severity are not yet well-known , but previous studies highlighted that relapse rate increased during influenzae epidemics, and air pollution could be a risk factor for MS relapses. MS is a neurological chronic disease that requires constant medical treatment and regular rehabilitation care. COVID-19 pandemic and restrictive measures taken to limit contaminations have drastically decreased air pollution and seasonal viral infections exposure, but sanitary crisis also limited care access for MS patients (medical treatment, rehabilitation). Therefore, this particular period offers a unique opportunity to evaluate the impact of air pollution, viral infections, and health care access on the severity of MS.

The main objective is to evaluate the impact of air pollution and seasonal viral infections on the risk of MS relapse, using the year 2020 as a quasi-experimental model. The secondary objective will be to evaluate the impact of health care access limitations on the risk of neurological disability accumulation.

This study will include 1500 MS patients, living in Ile de France, followed in the neurological department of "Pitié-Salpêtrière" Hospital. This is a retrospective observational study nested in OFSEP registry (French Multiple Sclerosis Observatory), which is a prospective cohort of MS patients in France. Air pollution data will come from AIRPARIF, and viral infections data will come from "Santé Publique France".

A better knowledge of the impact of air pollution, viral infections, and health care access on the course of MS will enable to better guide information to patients and public health care decisions.

详细描述

Multiple sclerosis (MS) is a common autoimmune disease of the central nervous system. The repetition of relapses and their severity will lead in the long term to the accumulation of disability. The risk factors for relapses are still poorly understood, but it is suspected that air pollution and seasonal viral infections may increase the risk of relapse.

The Sars-Cov-2 virus pandemic has abruptly disrupted the daily environment, to date three lock-down periods have been implemented, in France, to limit the spread of COVID 19, the first was from March 17 to May 11, 2020, the second was less strict from October 30 to December 15, 2020, and the third began April 3, 2021. The reduction in road traffic during the first containment was accompanied in Ile de France by a 30 to 50% decrease in fine particulate matter and nitrogen oxide air pollution compared to the previous year. The confinements and the generalized application of barrier measures have also been associated with a clear decrease in the circulation of seasonal viruses, in particular influenza and viral gastroenteritis viruses, compared to the previous year.

To date, the impact of measures to prevent the spread of the Sars-CoV-2 epidemic on the risk of MS relapse has not been studied. However, these periods offer a unique opportunity to assess, in a quasi-experimental model, the impact of air pollution and viral infections on the risk of MS relapse, in a context where these factors have shown large variations compared to the usual seasonal values observed.

The pandemic has also had a profound impact on the health care system, with the corollary that patients with chronic pathologies have had difficulty accessing care, as hospital structures have had to deal with an unprecedented crisis, resulting in the de-scheduling of non-urgent procedures and great difficulty in accessing in-person consultations. Numerous uncertainties concerning the risk of severe COVID-19 in patients treated with immune-modulators or immune-suppressors have led to the suspension or delay of the initiation of immuno-active treatments to prevent the aggravation of the disease. To date, no study has evaluated the impact of changes in the management of MS patients during this particular period and to assess the impact on the progression of neurological disability.

The primary objective of the study will be to determine the impact of environmental risk factors (air pollution, exposure to seasonal viruses) and health care access on the risk of clinical MS relapse, in the context of the lockdown periods, compared to periods prior to the COVID-19 pandemic.

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

  • MS defined by the Mac-Donald 2017 criteria
  • Age greater than or equal to 18 years
  • Relapsing-remitting form
  • Patient residing in Ile de France
  • Patient included in the OFSEP registry (French Multiple Sclerosis Observatory) with at least one visit before 2020 and at least one after January 2021

排除标准

  • Secondary progressive or primary progressive MS

结局指标

主要结局

Multiple Sclerosis Relapse

时间窗: 01/01/2018 - 01/01/2022

a neurologic deficit associated with an acute inflammatory demyelinating event that lasts at least 24 hours in the absence of fever and infection

次要结局

  • Neurological disability accumulation(01/01/2018 - 01/01/2022)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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