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

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19; Multiple Sclerosis

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 Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Rod M Middleton, MBA; Phone Number: 01792 602697; Email: r.m.middleton@swansea.ac.uk
• Study Contact Backup: Name: Katie A Tuite-Dalton, BSc

Study Locations

• United Kingdom
  • Swansea, United Kingdom, SA28PP
    • Recruiting
    • Swansea Univeristy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None of the above

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Swansea University
• Investigators: Principal Investigator: Richard S Nicholas, Clinical Lead; Principal Investigator: Nikos Evangelou, Co-PI

Publications and helpful links

Helpful Links

• Main study website
• Blog on the planned study

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 14, 2020
• Primary Completion (ANTICIPATED): July 14, 2022
• Study Completion (ANTICIPATED): July 14, 2022

Study Registration Dates

• First Submitted: April 6, 2020
• First Submitted That Met QC Criteria: April 20, 2020
• First Posted (ACTUAL): April 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Multiple Sclerosis; Sclerosis; COVID-19
• Other Study ID Numbers: 16SW0194

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Aggregate results will be published Line level data avaialble to other Researchers subject to Governance approval within Secure e-Research Platform

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No