Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04858763 |
| Other study ID # |
21NS011 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2021 |
| Est. completion date |
December 1, 2021 |
Study information
| Verified date |
April 2021 |
| Source |
Nottingham University Hospitals NHS Trust |
| Contact |
Nikos Evangelou |
| Phone |
07715172966 |
| Email |
Nikos.evangelou[@]nottingham.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
