NCT04354519

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2020

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2022

Completed
Last Updated

August 17, 2021

Status Verified

May 1, 2021

Enrollment Period

2.3 years

First QC Date

April 6, 2020

Last Update Submit

August 16, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

  • Patient Reported Expanded Disability Status Score

    1 year (at least 6 monthly)

  • Hospital Anxiety and Depression Scale

    1 year (at least 6 monthly)

  • Multiple Sclerosis Impact Scale 29 V2

    1 year (at least 6 monthly)

  • Multiple Sclerosis Walking Scale 12 V2

    1 year (at least 6 monthly)

  • Fatigue Severity Scale

    1 year (at least 6 monthly)

  • +1 more secondary outcomes

Study Arms (3)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • None of the above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swansea Univeristy

Swansea, SA28PP, United Kingdom

RECRUITING

Related Links

MeSH Terms

Conditions

Multiple SclerosisCOVID-19

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Richard S Nicholas

    Clinical Lead

    PRINCIPAL INVESTIGATOR
  • Nikos Evangelou

    Co-PI

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rod M Middleton, MBA

CONTACT

Katie A Tuite-Dalton, BSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2020

First Posted

April 21, 2020

Study Start

March 14, 2020

Primary Completion

July 14, 2022

Study Completion

July 14, 2022

Last Updated

August 17, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Aggregate results will be published Line level data avaialble to other Researchers subject to Governance approval within Secure e-Research Platform

Locations