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OpenTrials
Completed

NCT Number: NCT04858763

MS Relapses During COVID-19 Pandemic

Throughout the COVID-19 pandemic, and to our knowledge there have been no studies looking systematically at the occurrence of MS relapses and their subsequent management, during the peak of the first wave of the pandemic. In this study we will explore how MS relapses were reported and managed during April - June 2020, compared to a control cohort who experienced a relapse during the same period in 2019 across 5 UK centers.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Infections Lung Diseases Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Relapsing Remitting Multiple Sclerosis Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nottingham University Hospitals NHS Trust

Nottingham, NG72UH, United Kingdom

About this study

Multiple Sclerosis (MS) is a chronic inflammatory, demyelinating and neurodegenerative condition of the central nervous system (CNS) and is considered the most common cause of disability in young adults. It is estimated that the number of adults with MS in the UK has risen to 131,720. The majority of patients (85%) have Relapsing Remitting MS (RRMS), with many later entering the secondary progressive phase (SPMS). Relapse is the cardinal clinical feature of RRMS, and can be also prevalent in SPMS, however the influence of relapses on the long-term disability is not yet fully defined and remains controversial.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in Wuhan, China, in late 2019 and Covid-19, a disease caused by SARS-CoV-2 became a pandemic in March 2020. The impact of SARS-CoV-2 infection on patients with MS has yet to be elucidated. The main focus of previous studies has been the actual risk of Covid-19 inpatients with MS, the risk of MS exacerbation during Covid-19 infection and the impact of disease modifying drugs (DMDs) in the severity of Covid-19 infection. Other studies have explored the psychological and behavioural impact of Covid-19 pandemic to MS patients; those studies highlighted the risks from missing/cancelling clinic appointments and MRIs, missing/stopping/changing DMDs, delays in DMDs infusions, having a relapse and not seeking medical advice or disruptions in rehabilitation services. To the best of our knowledge, there is currently no study that explored the effect of Covid-19 on MS patients by looking systematically into MS relapses and their potential consequences. We will study the occurrence and subsequent management of relapses occurring between April - June 2020 at the peak of the first wave of the pandemic, compared to individuals who have relapsed during the same period in 2019. This observational, retrospective study will be performed at 5 UK sites.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a confirmed diagnosis of MS or Clinically Isolated Syndrome (CIS) and
  • Atleast one clinician confirmed probable relapse between 01/04/2020 and 30/06/2020 or 01/04/2019 and 30/06/2019

Exclusion criteria

  • Age <16 years

Treatment and study plan

No intervention

Other

There will be no intervention during this study.

Primary outcomes

  1. The number of MS relapses during the first wave of the Covid-19 pandemic and in the same period in 2019.

    Time frame: 01/04/2020 and 30/06/2020 or 01/04/2019 and 30/06/2019

Secondary outcomes

  1. 1. The decisions made about administration of DMDs (starting or switching to a DMD) when a patient with MS has a relapse during the Covid-19 pandemic and in the same period in 2019.

    Time frame: 01/04/2020 and 30/06/2020 or 01/04/2019 and 30/06/2019

  2. 2. The decisions around treating an MS relapse with steroids during the Covid-19 pandemic and the same period in 2019.

    Time frame: 01/04/2020 and 30/06/2020 or 01/04/2019 and 30/06/2019

Sponsors and collaborators

Lead sponsor

Nottingham University Hospitals NHS Trust

Other

Registry information

Official study title

The Impact of the COVID-19 Pandemic on the Reporting and Management of Multiple Sclerosis Relapses

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Apr 26, 2021
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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