MS Relapses During COVID-19 Pandemic

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Covid19; Relapsing Remitting Multiple Sclerosis
• Intervention / Treatment: Other: No Intervention

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG72UH
    • Nottingham University Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All individuals with MS or CIS being treated by the respective UK sites will be screened for inclusion in this study.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
2020 Cohort; This is the 2020 MS cohort who experienced a clinician confirmed relapse during April - June 2020, during the first wave of the COVID-19 pandemic.	Other: No Intervention; There will be no intervention during this study.
2019 Cohort; 2019 MS cohort who experienced a clinician confirmed relapse during April - June 2019.	Other: No Intervention; There will be no intervention during this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of MS relapses during the first wave of the Covid-19 pandemic and in the same period in 2019.	01/04/2020 and 30/06/2020 or 01/04/2019 and 30/06/2019

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	01/04/2020 and 30/06/2020 or 01/04/2019 and 30/06/2019
2. The decisions around treating an MS relapse with steroids during the Covid-19 pandemic and the same period in 2019.	01/04/2020 and 30/06/2020 or 01/04/2019 and 30/06/2019

Collaborators and Investigators

• Sponsor: Nottingham University Hospitals NHS Trust
• Investigators: Principal Investigator: Nikos Evangelou, University of Nottingham

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): June 28, 2022
• Study Completion (Actual): June 20, 2023

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: 21NS011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share any identifiable patient data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No