COVID-19 and Multiple Sclerosis Disease Modifying Therapies

Multiple Sclerosis Clinical Trial

Official title:

Prevalence of Coronavirus Disease 2019 in People With Multiple Sclerosis Taking Disease Modifying Therapies in England

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04863586
• Other study ID #: 20NS041
• Status: Enrolling by invitation
• Start date: April 1, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: April 2021
• Source: Nottingham University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 14240
• Est. completion date: May 31, 2022
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or above

• Diagnosed with MS

• Received treatment with a DMT

Exclusion Criteria:

• Not fulfilling the inclusion criteria

Related Conditions & MeSH terms

• Covid19
• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
Nottingham University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of testing positive for SARS-CoV-2 in people with MS taking DMTs	The number of people with MS taking DMTs who have tested positive for SARS-CoV-2 among all people with MS taking DMTs in England.	6 months
Secondary	Clinical outcomes of COVID-19 among people with MS taking DMTs	To determine the clinical outcomes of COVID-19 (e.g., severity of disease, death, and recovery) in people with MS taking DMTs in England	6 months
Secondary	Risk of contracting COVID-19 associated with individual DMTs/other clinical and paraclinical factors	To assess the risk of contracting COVID-19 associated with individual DMTs and other clinical (e.g., physical disability and comorbidities) and paraclinical (e.g., white blood cell and lymphocyte counts, vitamin D levels) factors among people with MS taking DMTs in England	6 months
Secondary	Association between clinical outcomes of COVID-19 and individual DMTs/other clinical and paraclinical factors	To assess the association between clinical outcomes of COVID-19 and individual DMTs or other clinical (e.g., physical disability and comorbidities) and paraclinical (e.g., white blood cell and lymphocyte counts, vitamin D levels) factors among people with MS taking DMTs in England	6 months