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The United Kingdom Multiple Sclerosis Register Covid-19 Substudy (UKMSRCV19)

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
Sponsor:
Information provided by (Responsible Party):
Swansea University

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

Condition or disease
Multiple Sclerosis COVID-19

Detailed Description:

Study objectives

  1. 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
  2. To establish if some DMDs increase the risk of COVID-19 infection
  3. 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.
  4. 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.
  5. 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.
  6. To determine where people are obtaining their health information during the COVID-19 outbreak.
  7. To establish changes in DMDs prior to and as a result of symptoms related and unrelated to COVID-19
Study Design
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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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
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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None of the above
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Rod M Middleton, MBA 01792 602697 r.m.middleton@swansea.ac.uk
Contact: Katie A Tuite-Dalton, BSc

Locations
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United Kingdom
Swansea Univeristy Recruiting
Swansea, United Kingdom, SA28PP
Sponsors and Collaborators
Swansea University
Investigators
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Principal Investigator: Richard S Nicholas Clinical Lead
Principal Investigator: Nikos Evangelou Co-PI
  Study Documents (Full-Text)

Documents provided by Swansea University:
Study Protocol  [PDF] March 26, 2020

More Information
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Additional Information:

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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