The United Kingdom Multiple Sclerosis Register Covid-19 Substudy (UKMSRCV19)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04354519 |
Recruitment Status :
Recruiting
First Posted : April 21, 2020
Last Update Posted : August 17, 2021
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Condition or disease |
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Multiple Sclerosis COVID-19 |
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 Type : | Observational [Patient Registry] |
Estimated Enrollment : | 3000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 1 Year |
Official Title: | The UK MS Regsiter COVID-19 Substudy |
Actual Study Start Date : | March 14, 2020 |
Estimated Primary Completion Date : | July 14, 2022 |
Estimated Study Completion Date : | July 14, 2022 |

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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
Inclusion Criteria:
- >18 and confirmed diagnosis of MS, enrolled on UK MS Register
Exclusion Criteria:
- None of the above

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04354519
Contact: Rod M Middleton, MBA | 01792 602697 | r.m.middleton@swansea.ac.uk | |
Contact: Katie A Tuite-Dalton, BSc |
United Kingdom | |
Swansea Univeristy | Recruiting |
Swansea, United Kingdom, SA28PP |
Principal Investigator: | Richard S Nicholas | Clinical Lead | |
Principal Investigator: | Nikos Evangelou | Co-PI |
Responsible Party: | Swansea University |
ClinicalTrials.gov Identifier: | NCT04354519 |
Other Study ID Numbers: |
16SW0194 |
First Posted: | April 21, 2020 Key Record Dates |
Last Update Posted: | August 17, 2021 |
Last Verified: | May 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Aggregate results will be published Line level data avaialble to other Researchers subject to Governance approval within Secure e-Research Platform |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Multiple Sclerosis Sclerosis Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections |
RNA Virus Infections Lung Diseases Respiratory Tract Diseases Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |