The United Kingdom Multiple Sclerosis Register Covid-19 Substudy

An observational study of Multiple Sclerosis and COVID-19, run by Swansea University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The aim of the study is to understand the impact of COVID-19 on People with Multiple Sclerosis in the United Kingdom. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Sclerosis, COVID-19
How many people: 3,000 participants
Where: 1 siteUnited Kingdom
Study dates: 14 Mar 2020to 14 Jul 2022
How long will I take part?: 1 Year
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: PwMS in the UK who self report as having MS, or have been recruited at a clinical site. Given the potentially vulnerable nature of pwMS due to active drug treatment and their potential susceptibility to infection it is important to chart this population within the MS Register

Who may be able to join

>18 and confirmed diagnosis of MS, enrolled on UK MS Register

Who cannot join

None of the above

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Swansea Univeristy
Swansea, SA28PP

Other trials in United Kingdom

About this study

Official title: The UK MS Regsiter COVID-19 Substudy

The aim of the study is to understand the impact of COVID-19 on People with Multiple Sclerosis in the United Kingdom.

Read the detailed description

Study objectives

To identify the incidence of upper respiratory tract symptoms: fever, cough and breathing difficulties, other symptoms suggestive of COVID-19 infection, respiratory tract infections suggestive of COVID-19, and COVID-19 confirmed by laboratory testing among the UK MS population
To establish if some DMDs increase the risk of COVID-19 infection
To determine the incidence and effectiveness of self-isolation in the MS population. To examine the impact self-isolation has on mood, fatigue, and other routinely collected patient reported outcome measures from the MS Register.
To determine the clinical outcome of respiratory tract infections, including confirmed and suspected cases of COVID-19, in terms of symptoms, time to recovery, hospital admission, requirement for ventilation, and death.
To determine the longer-term impact of COVID-19 on MS, using routinely collected MS outcomes in the MS register, including impact on disability, relapses and changes in DMDs as assessed at 3 monthly intervals.
To determine where people are obtaining their health information during the COVID-19 outbreak.
To establish changes in DMDs prior to and as a result of symptoms related and unrelated to COVID-19

Conditions: Multiple Sclerosis, COVID-19
Medical subject headings: Multiple Sclerosis, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04354519
Study group	Role	What they receive
Confirmed Cases		Diagnosed by health professional / Covid-19 test Monitored through fortnightly questionnaires
Not Covid-19 cases		Through self report no suspicion of COVID-19, tested by fortnightly questionnaire. non Covid Cases can become COVID cases through self report.
Suspected Covid-19 Cases		Participants that are suspected of having Covid-19 but this has not been confirmed by health professional or Covid-19 test has not been performed. Fortnighly questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of COVID-19 Infections within an MS Cohort in the UK
Targeted questionnaire dependent on COVID Status
Measured: Through study completion, an average of 1 year
Hospitalisations in MS Patients with COVID-19
Monitor admission rates in linked population
Measured: 1 Year (regular outputs)
Mortality
Death data from routinely reported government level data (HES/PEDW)
Measured: 1 Year from study commencement

Secondary outcomes (6)

Patient Reported Expanded Disability Status Score
Patient Reported Outcome for MS disability
Measured: 1 year (at least 6 monthly)
Hospital Anxiety and Depression Scale
Patient Reported Outcome for anxiety and depression
Measured: 1 year (at least 6 monthly)
Multiple Sclerosis Impact Scale 29 V2
Patient Reported Outcome for Multiple sclerosis impact on physical and psychological status
Measured: 1 year (at least 6 monthly)
Multiple Sclerosis Walking Scale 12 V2
Patient Reported Outcome for walking status
Measured: 1 year (at least 6 monthly)
Fatigue Severity Scale
Patient Reported Outcome for impact of fatigue
Measured: 1 year (at least 6 monthly)
EuroQol 5D (3l)
Patient Reported Outcome for general quality of life
Measured: 1 year (at least 6 monthly)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Mar 202014 Jul 2022

First posted21 Apr 2020
Study start14 Mar 2020
Primary completion14 Jul 2022
Study completion14 Jul 2022

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: Prospective
Enrolment: 3,000 participants (actual)
Target duration: 1 Year

IDs, dates and publications

ClinicalTrials.gov ID: NCT04354519
Sponsor's protocol ID: 16SW0194
Acronym: UKMSRCV19
Status last verified: May 2022
First submitted: 6 Apr 2020
Last updated: 6 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Aggregate results will be published Line level data avaialble to other Researchers subject to Governance approval within Secure e-Research Platform

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Multiple Sclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The UK MS Regsiter COVID-19 Substudy
ClinicalTrials.gov ID: NCT04354519
Acronym / sponsor ID: UKMSRCV19 / 16SW0194
Conditions: Multiple Sclerosis, COVID-19
Study type: Observational
Recruitment status: Completed
Enrolment: 3,000 participants (actual)
Lead sponsor: Swansea UniversityUniversity, hospital or other
Study start: 14 Mar 2020 (actual)
Primary completion: 14 Jul 2022 (actual)
Study completion: 14 Jul 2022 (actual)
First posted: 21 Apr 2020 (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.

The aim of the study is to understand the impact of COVID-19 on People with Multiple Sclerosis in the United Kingdom.

Detailed description

Study objectives

To identify the incidence of upper respiratory tract symptoms: fever, cough and breathing difficulties, other symptoms suggestive of COVID-19 infection, respiratory tract infections suggestive of COVID-19, and COVID-19 confirmed by laboratory testing among the UK MS population
To establish if some DMDs increase the risk of COVID-19 infection
To determine the incidence and effectiveness of self-isolation in the MS population. To examine the impact self-isolation has on mood, fatigue, and other routinely collected patient reported outcome measures from the MS Register.
To determine the clinical outcome of respiratory tract infections, including confirmed and suspected cases of COVID-19, in terms of symptoms, time to recovery, hospital admission, requirement for ventilation, and death.
To determine the longer-term impact of COVID-19 on MS, using routinely collected MS outcomes in the MS register, including impact on disability, relapses and changes in DMDs as assessed at 3 monthly intervals.
To determine where people are obtaining their health information during the COVID-19 outbreak.
To establish changes in DMDs prior to and as a result of symptoms related and unrelated to COVID-19

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 1 Year
Number of arms: 3

Arm	Type	Receives
Confirmed Cases	–	–Diagnosed by health professional / Covid-19 test Monitored through fortnightly questionnaires
Not Covid-19 cases	–	–Through self report no suspicion of COVID-19, tested by fortnightly questionnaire. non Covid Cases can become COVID cases through self report.
Suspected Covid-19 Cases	–	–Participants that are suspected of having Covid-19 but this has not been confirmed by health professional or Covid-19 test has not been performed. Fortnighly questionnaire

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: PwMS in the UK who self report as having MS, or have been recruited at a clinical site. Given the potentially vulnerable nature of pwMS due to active drug treatment and their potential susceptibility to infection it is important to chart this population within the MS Register

Key inclusion criteria (1 listed)

>18 and confirmed diagnosis of MS, enrolled on UK MS Register

Key exclusion criteria (1 listed)

None of the above

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Incidence of COVID-19 Infections within an MS Cohort in the UK
Time frame: Through study completion, an average of 1 year
Targeted questionnaire dependent on COVID Status
Hospitalisations in MS Patients with COVID-19
Time frame: 1 Year (regular outputs)
Monitor admission rates in linked population
Mortality
Time frame: 1 Year from study commencement
Death data from routinely reported government level data (HES/PEDW)

6 secondary outcomes

Patient Reported Expanded Disability Status Score
Time frame: 1 year (at least 6 monthly)
Hospital Anxiety and Depression Scale
Time frame: 1 year (at least 6 monthly)
Multiple Sclerosis Impact Scale 29 V2
Time frame: 1 year (at least 6 monthly)
Multiple Sclerosis Walking Scale 12 V2
Time frame: 1 year (at least 6 monthly)
Fatigue Severity Scale
Time frame: 1 year (at least 6 monthly)
EuroQol 5D (3l)
Time frame: 1 year (at least 6 monthly)

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 6 Jul 2026.
Main study websiteLink provided by the sponsor.
Blog on the planned studyLink provided by the sponsor.
Individual participant dataSharing planned: No. Aggregate results will be published Line level data avaialble to other Researchers subject to Governance approval within Secure e-Research Platform

Related trials for Multiple Sclerosis

Recruiting
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Multiple Sclerosis
RecruitingObservational study
Study of the Disease Process of Lymphangioleiomyomatosis
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RecruitingPhase 2
A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)
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Stopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study
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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.

Richard S Nicholas principal investigator

Clinical Lead

Nikos Evangelou principal investigator

Co-PI

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 COVID-19, run by Swansea University 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 1 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 6 Jul 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?

Incidence of COVID-19 Infections within an MS Cohort in the UK (time frame: Through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04354519.

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 6 Jul 2026.