The United Kingdom Multiple Sclerosis Register Covid-19 Substudy (UKMSRCV19)
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|ClinicalTrials.gov Identifier: NCT04354519|
Recruitment Status : Recruiting
First Posted : April 21, 2020
Last Update Posted : June 22, 2020
|Condition or disease|
|Multiple Sclerosis COVID-19|
- 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
- To establish if some DMDs increase the risk of COVID-19 infection
- 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.
- 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.
- 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.
- To determine where people are obtaining their health information during the COVID-19 outbreak.
- To establish changes in DMDs prior to and as a result of symptoms related and unrelated to COVID-19
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||3000 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||The UK MS Regsiter COVID-19 Substudy|
|Actual Study Start Date :||March 14, 2020|
|Estimated Primary Completion Date :||July 14, 2021|
|Estimated Study Completion Date :||July 14, 2022|
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.
- Incidence of COVID-19 Infections within an MS Cohort in the UK [ Time Frame: Through study completion, an average of 1 year ]Targeted questionnaire dependent on COVID Status
- Hospitalisations in MS Patients with COVID-19 [ Time Frame: 1 Year (regular outputs) ]Monitor admission rates in linked population
- Mortality [ Time Frame: 1 Year from study commencement ]Death data from routinely reported government level data (HES/PEDW)
- Patient Reported Expanded Disability Status Score [ Time Frame: 1 year (at least 6 monthly) ]Patient Reported Outcome for MS disability
- Hospital Anxiety and Depression Scale [ Time Frame: 1 year (at least 6 monthly) ]Patient Reported Outcome for anxiety and depression
- Multiple Sclerosis Impact Scale 29 V2 [ Time Frame: 1 year (at least 6 monthly) ]Patient Reported Outcome for Multiple sclerosis impact on physical and psychological status
- Multiple Sclerosis Walking Scale 12 V2 [ Time Frame: 1 year (at least 6 monthly) ]Patient Reported Outcome for walking status
- Fatigue Severity Scale [ Time Frame: 1 year (at least 6 monthly) ]Patient Reported Outcome for impact of fatigue
- EuroQol 5D (3l) [ Time Frame: 1 year (at least 6 monthly) ]Patient Reported Outcome for general quality of life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04354519
|Contact: Rod M Middleton, MBA||01792 firstname.lastname@example.org|
|Contact: Katie A Tuite-Dalton, BSc|
|Swansea, United Kingdom, SA28PP|
|Principal Investigator:||Richard S Nicholas||Clinical Lead|
|Principal Investigator:||Nikos Evangelou||Co-PI|