Clinical trial NCT04858763: MS Relapses During COVID-19 Pandemic
Official title: The Impact of the COVID-19 Pandemic on the Reporting and Management of Multiple Sclerosis Relapses
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Covid19
Relapsing Remitting Multiple Sclerosis
Lead sponsor: Nottingham University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 340
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Compare the number of MS relapses during the first wave of the Covid-19 pandemic to the same period in 2019.
timeFrame: 01/04/2020 and 30/06/2020 or 01/04/2019 and 30/06/2019
Secondary outcomes:
measure: 1. To compare 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.
timeFrame: 01/04/2020 and 30/06/2020 or 01/04/2019 and 30/06/2019
measure: 2. To compare decisions around treating an MS relapse with steroids during the Covid-19 pandemic and the same period in 2019.
timeFrame: 01/04/2020 and 30/06/2020 or 01/04/2019 and 30/06/2019
Other outcomes:
Locations:
Study officials:
affiliation: University of Nottingham
name: Nikos Evangelou
role: PRINCIPAL_INVESTIGATOR
References: