Clinical trial NCT04354519: The United Kingdom Multiple Sclerosis Register Covid-19 Substudy
Official title: The UK MS Regsiter COVID-19 Substudy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
COVID-19
Lead sponsor: Swansea University
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None of the above

Primary outcomes:
measure: Incidence of COVID-19 Infections within an MS Cohort in the UK
timeFrame: Through study completion, an average of 1 year
measure: Hospitalisations in MS Patients with COVID-19
timeFrame: 1 Year (regular outputs)
measure: Mortality
timeFrame: 1 Year from study commencement
Secondary outcomes:
measure: Patient Reported Expanded Disability Status Score
timeFrame: 1 year (at least 6 monthly)
measure: Hospital Anxiety and Depression Scale
timeFrame: 1 year (at least 6 monthly)
measure: Multiple Sclerosis Impact Scale 29 V2
timeFrame: 1 year (at least 6 monthly)
measure: Multiple Sclerosis Walking Scale 12 V2
timeFrame: 1 year (at least 6 monthly)
measure: Fatigue Severity Scale
timeFrame: 1 year (at least 6 monthly)
measure: EuroQol 5D (3l)
timeFrame: 1 year (at least 6 monthly)
Other outcomes:
Locations:
city: Swansea
country: United Kingdom
facility: Swansea Univeristy
Study officials:
affiliation: Clinical Lead
name: Richard S Nicholas
role: PRINCIPAL_INVESTIGATOR
affiliation: Co-PI
name: Nikos Evangelou
role: PRINCIPAL_INVESTIGATOR
References: