COVID-19 and Multiple Sclerosis Disease Modifying Therapies

NCT ID: NCT04863586

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 14240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2022-05-31

Brief Summary

The COVID-19 pandemic is a major concern for people on long-term treatments that modify the immune system function. People with multiple sclerosis (pwMS) form a large group who receive such treatments called disease modifying therapies (DMTs). Several types of DMTs with different effects on the immune system are being used for multiple sclerosis (MS). In the absence of large-scale national studies, the risk of COVID-19 among pwMS on various DMTs has not been established.

A few physician-reported registry-based studies have suggested that anti-CD20 monoclonal antibodies, such as ocrelizumab and rituximab, used in the treatment of MS can increase the risk of COVID-19. However, in our community-based COVID-19 study of a large cohort of pwMS as part of the UK MS Register, we could not demonstrate an association between DMTs and susceptibility to COVID-19. Other studies have not found any relationship between DMTs and the outcome of COVID-19 among pwMS.

To our knowledge, UK is the only country in the world that collects national data on DMT use, providing us with the opportunity to investigate the impact of DMTs on COVID-19 susceptibility and severity in a large population of pwMS. In England, no DMT is being dispensed without prior approval and specialised commissioning by the national Health Services (NHS) England & NHS Improvement (NHSE/I). The scheme, currently implemented in over 100 NHS Trusts in England, ensures that treatment decisions are made in line with agreed commissioning policy and are evidence-based. NHSE/I also has access to Public Health England (PHE) held data on all people who have had a SARS-CoV-2 test. By identifying all pwMS on DMTs and all those who have had a test for coronavirus and collecting data on the clinical outcome of their COVID-19 from their local NHS hospitals, we would be able to establish the risk of COVID-19 and the risk of contracting the infection associated with different DMTs. The findings of the study will help MS clinical teams address the concerns of pwMS about taking DMTs during the COVID-19 pandemic and update their guidelines on the measures pwMS need to take during these unprecedented times.

Conditions

Covid19; Multiple Sclerosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Tested positive for SARS-CoV-2

Eligible participants who have had a positive SARS-CoV-2 test will be included in the case group of the study.

No interventions assigned to this group

Not tested for SARS-CoV-2

A random sample of age, sex, and DMT matched people with MS who have not been tested for SARS-CoV-2 will be included in the control group of the study.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age 18 or above
• Diagnosed with MS
• Received treatment with a DMT

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nottingham University Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nikos Evangelou, FRCP

Role: PRINCIPAL_INVESTIGATOR

Nottingham University Hospitals NHS Trust

Locations

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, United Kingdom

Countries

United Kingdom

Other Identifiers

20NS041

Identifier Type: -

Identifier Source: org_study_id