The United Kingdom Multiple Sclerosis Register Covid-19 Substudy

NCT ID: NCT04354519

Last Updated: 2021-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-14

Study Completion Date

2022-07-14

Brief Summary

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

Detailed Description

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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

Conditions

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Multiple Sclerosis COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Confirmed Cases

Diagnosed by health professional / Covid-19 test

Monitored through fortnightly questionnaires

No interventions assigned to this group

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.

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None of the above
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swansea University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard S Nicholas

Role: PRINCIPAL_INVESTIGATOR

Clinical Lead

Nikos Evangelou

Role: PRINCIPAL_INVESTIGATOR

Co-PI

Locations

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Swansea Univeristy

Swansea, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Rod M Middleton, MBA

Role: CONTACT

01792 602697

Katie A Tuite-Dalton, BSc

Role: CONTACT

Provided Documents

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Document Type: Study Protocol

View Document

Related Links

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Other Identifiers

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16SW0194

Identifier Type: -

Identifier Source: org_study_id

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