MS Relapses During COVID-19 Pandemic

NCT04858763 | Completed

• 1 other identifier: 21NS011
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis; Covid19; Relapsing Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

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

2019 Cohort

2019 MS cohort who experienced a clinician confirmed relapse during April - June 2019.

Other: No Intervention

Interventions

No Intervention OTHER

There will be no intervention during this study.

2019 Cohort; 2020 Cohort

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Age \<16 years

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, NG72UH, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis; COVID-19; Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nikos Evangelou

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 26, 2021
• Study Start: July 1, 2021
• Primary Completion: June 28, 2022
• Study Completion: June 20, 2023
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)