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Completed

NCT Number: NCT04354519

The United Kingdom Multiple Sclerosis Register 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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System COVID-19 Coronaviridae Infections Coronavirus Infections Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Infections Lung Diseases Nervous System Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Swansea Univeristy

Swansea, SA28PP, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None of the above

Treatment and study plan

Primary outcomes

  1. 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

  2. Hospitalisations in MS Patients with COVID-19

    Time frame: 1 Year (regular outputs)

    Monitor admission rates in linked population

  3. Mortality

    Time frame: 1 Year from study commencement

    Death data from routinely reported government level data (HES/PEDW)

Secondary outcomes

  1. Patient Reported Expanded Disability Status Score

    Time frame: 1 year (at least 6 monthly)

    Patient Reported Outcome for MS disability

  2. Hospital Anxiety and Depression Scale

    Time frame: 1 year (at least 6 monthly)

    Patient Reported Outcome for anxiety and depression

  3. 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

  4. Multiple Sclerosis Walking Scale 12 V2

    Time frame: 1 year (at least 6 monthly)

    Patient Reported Outcome for walking status

  5. Fatigue Severity Scale

    Time frame: 1 year (at least 6 monthly)

    Patient Reported Outcome for impact of fatigue

  6. EuroQol 5D (3l)

    Time frame: 1 year (at least 6 monthly)

    Patient Reported Outcome for general quality of life

Sponsors and collaborators

Lead sponsor

Swansea University

Other

Registry information

Official study title

The UK MS Regsiter COVID-19 Substudy

Acronym: UKMSRCV19

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 21, 2020
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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