COVID-19 & Multiple Sclerosis Disease Modifying Therapies

Status Enrolling by invitation

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04863586
Study type	Observational
Source	Nottingham University Hospitals NHS Trust
Contact
Status	Enrolling by invitation
Phase
Start date	April 1, 2021
Completion date	May 31, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05528666` - Risk Perception in Multiple Sclerosis
Completed	`NCT03608527` - Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis	N/A
Recruiting	`NCT05532943` - Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis	Phase 1/Phase 2
Completed	`NCT02486640` - Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
Completed	`NCT01324232` - Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis	Phase 2
Completed	`NCT04546698` - 5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
Active, not recruiting	`NCT04380220` - Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
Completed	`NCT02835677` - Integrating Caregiver Support Into MS Care	N/A
Completed	`NCT03686826` - Feasibility and Reliability of Multimodal Evoked Potentials
Recruiting	`NCT05964829` - Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis	N/A
Withdrawn	`NCT06021561` - Orofacial Pain in Multiple Sclerosis
Completed	`NCT03653585` - Cortical Lesions in Patients With Multiple Sclerosis
Recruiting	`NCT04798651` - Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis	N/A
Active, not recruiting	`NCT05054140` - Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis	Phase 2
Completed	`NCT05447143` - Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis	N/A
Recruiting	`NCT06195644` - Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients	Phase 1
Completed	`NCT04147052` - iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis	N/A
Completed	`NCT03594357` - Cognitive Functions in Patients With Multiple Sclerosis
Completed	`NCT03591809` - Combined Exercise Training in Patients With Multiple Sclerosis	N/A
Completed	`NCT03269175` - BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

COVID-19 and Multiple Sclerosis Disease Modifying Therapies

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms