Multiple SclerosisNCT04858763
MS Relapses During COVID-19 Pandemic
An observational study of Multiple Sclerosis and Covid19, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Covid19, Relapsing Remitting Multiple Sclerosis
- How many people
- 51 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2021to 20 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All individuals with MS or CIS being treated by the respective UK sites will be screened for inclusion in this study.
Who may be able to join
- 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
Who cannot join
- Age <16 years
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hospitals NHS Trust
Nottingham, NG72UH
About this study
Official title: 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.
Read the 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.
- Being tested
- No Intervention
- Medical subject headings
- Multiple Sclerosis, COVID-19, Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
There will be no intervention during this study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No Intervention | |
| 2019 Cohort | 2019 MS cohort who experienced a clinician confirmed relapse during April - June 2019. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of MS relapses during the first wave of the Covid-19 pandemic and in the same period in 2019.
Measured: 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.
Measured: 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.
Measured: 01/04/2020 and 30/06/2020 or 01/04/2019 and 30/06/2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Jul 2021
- Primary completion28 Jun 2022
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikos Evangelou, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858763
- Sponsor's protocol ID
- 21NS011
- Status last verified
- Mar 2026
- First submitted
- 22 Apr 2021
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share any identifiable patient data.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the COVID-19 Pandemic on the Reporting and Management of Multiple Sclerosis Relapses
- ClinicalTrials.gov ID
- NCT04858763
- Acronym / sponsor ID
- 21NS011
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2020 Cohort | – | Other: No InterventionThis is the 2020 MS cohort who experienced a clinician confirmed relapse during April - June 2020, during the first wave of the COVID-19 pandemic. |
| 2019 Cohort | – | Other: No Intervention2019 MS cohort who experienced a clinician confirmed relapse during April - June 2019. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All individuals with MS or CIS being treated by the respective UK sites will be screened for inclusion in this study.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Age <16 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThere will be no intervention during this study. | Other | 2019 Cohort, 2020 Cohort |
Primary outcome
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
2 secondary outcomes
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. 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No. There is no plan to share any identifiable patient data.
Related trials for Multiple Sclerosis
RecruitingPhase 3
Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
Relapsing Multiple Sclerosis
Active, not recruitingObservational study
A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Study of Skin Tumors in Tuberous Sclerosis
Tuberous Sclerosis
Recruiting
The Effects of Synchronous and Asynchronous Pilates Training Based on Telerehabilitation on Core Stabilization, Balance, Cognitive Functions, and Quality of Life in Individuals With Multiple Sclerosis: A Single-Blind Randomized Controlled Trial
Multiple Sclerosis
RecruitingObservational study
Care in Multiple Sclerosis (MS)
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikos Evangelou principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Covid19, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.