The United Kingdom Multiple Sclerosis Register Covid-19 Substudy

COVID-19 Clinical Trial

— UKMSRCV19  

Official title:

The UK MS Regsiter COVID-19 Substudy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04354519
• Other study ID #: 16SW0194
• Status: Recruiting
• Start date: March 14, 2020
• Est. completion date: July 14, 2022

Study information

• Verified date: May 2021
• Source: Swansea University
• Contact: Rod M Middleton, MBA
• Phone: 01792 602697
• Email: r.m.middleton[@]swansea.ac.uk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: July 14, 2022
• Est. primary completion date: July 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None of the above

Related Conditions & MeSH terms

• COVID-19
• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United Kingdom	Swansea Univeristy	Swansea

Sponsors (1)

Lead Sponsor	Collaborator
Swansea University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Hospitalisations in MS Patients with COVID-19	Monitor admission rates in linked population	1 Year (regular outputs)
Primary	Mortality	Death data from routinely reported government level data (HES/PEDW)	1 Year from study commencement
Secondary	Patient Reported Expanded Disability Status Score	Patient Reported Outcome for MS disability	1 year (at least 6 monthly)
Secondary	Hospital Anxiety and Depression Scale	Patient Reported Outcome for anxiety and depression	1 year (at least 6 monthly)
Secondary	Multiple Sclerosis Impact Scale 29 V2	Patient Reported Outcome for Multiple sclerosis impact on physical and psychological status	1 year (at least 6 monthly)
Secondary	Multiple Sclerosis Walking Scale 12 V2	Patient Reported Outcome for walking status	1 year (at least 6 monthly)
Secondary	Fatigue Severity Scale	Patient Reported Outcome for impact of fatigue	1 year (at least 6 monthly)
Secondary	EuroQol 5D (3l)	Patient Reported Outcome for general quality of life	1 year (at least 6 monthly)

External Links

•   Blog on the planned study
•   Main study website