The Effect of Covid-19 on the Disease Course of Multiple Sclerosis :Belgian Lessons Learned From Rocky I to Rocky IV (TofCoMS)

The Effect of Covid-19 on the Disease Course of Multiple Sclerosis

Retrospective observational cohort study. ToFCoMS: two years of follow-up of COVID-19 in MS.

Study Overview

• Status: Completed
• Conditions: COVID-19

Detailed Description

Methods The Nationaal Multiple Sclerose Centrum (NMSC) Melsbroek is a large highly-specialized center specifically focusing on neurological management, multidisciplinary care and rehabilitation in patients with MS. Since March 2020 (i.e., the onset of the pandemic in Belgium, and the first of five waves of spiking infection numbers thus far in our country), clinical data of patients followed at the center have been collected in a local database in case of COVID-19 diagnosis. The following items have been recorded: name, gender and date of COVID-19 diagnosis; age, Expanded Disability Status Scale score, MS duration, clinical subtype and DMT regimen at time of COVID-19 diagnosis; COVID-19 severity (method 1: categorized as ambulatory, hospitalized, death; method 2: categorized as asymptomatic, mild illness, moderate illness, severe illness, critical illness and death); vaccination status (categorized as non-vaccinated, fully vaccinated, fully vaccinated + booster) at time of COVID-19 diagnosis. On February 28, 2022, this database was locked and consisted of 234180 unique individual COVID-19 cases.

The NMSC Melsbroek features a second and more large database containing a broad variety of (para)clinical information gathered during routine follow-up, which includes regular testing of general disability with the EDSS, leg function/ambulation with the Timed 25-Foot Walk Test (T25FWT), hand function/dexterity using the 9-Hole Peg Test (9HPT) and cognition/information processing speed with the Symbol Digit Modalities Test (SDMT). For each of these parameters, the first two assessments before COVID-19 diagnosis (labelled T0 and T1, respectively; T1 is the closest to COVID-19 diagnosis), and the first thereafter (labelled T2), were retrieved for each COVID-19 subject. If clinical measurements were performed during an in-house stay for rehabilitation purposes, only those performed on admission were retained (thus not necessarily those the closest to the COVID-19 infection).

• Study Type: Observational
• Enrollment (Actual): 230

Contacts and Locations

Study Locations

• Belgium
  • Vlaams Brabant
    • Melsbroek, Vlaams Brabant, Belgium, 1820
      • Nationaal MS center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

MS patients with Covid 19 infection

Description

Inclusion Criteria:

diagnosis of Multiple Sclerosis Covid 19 infection with PCR test

Exclusion Criteria:

other diagnosis than Multiple Sclerosis

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The investigators hereby aim to answer the question whether COVID-19 affects the progression of clinical disability in MS	The difference between the values measured at T-2 and T-1 (i.e., before COVID-19) will be compared, after adjustment for the time interval, with the difference between the respective values measured at T-1 and T1 (i.e., after COVID-19) for T25WT, 9HPT and SDMT. The investigators hereby aim to answer the question whether COVID-19 affects the progression of clinical disability in MS. Its effect on SDMT evolution has been defined as the primary endpoint of our study.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vaccination status and progression MS	As secondary outcomes, the investigators want to explore whether (a) there is a relationship between COVID-19 severity and the evolution of clinical disability (i.e., differences between T-1 and T1), (b) vaccination status affects COVID-19 severity (in the total cohort as well as stratified according to DMT) and evolution of clinical disability (i.e., differences between T-1 and T1) and (c) DMT influences COVID-19 severity and evolution of clinical disability (i.e., differences between T-1 and T1).	2 years

Collaborators and Investigators

• Sponsor: Marie D'hooghe

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: June 2, 2022
• First Submitted That Met QC Criteria: June 2, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 3, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Multiple Sclerosis; COVID-19; Disease Progression
• Other Study ID Numbers: TofComs

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: no IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No