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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05403463
Recruitment Status : Completed
First Posted : June 3, 2022
Last Update Posted : June 8, 2022
Information provided by (Responsible Party):
Marie D'hooghe, National MS Center Melsbroek

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

Condition or disease

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).

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Study Type : Observational
Actual Enrollment : 230 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: The Effect of Covid-19 on the Disease Course of Multiple Sclerosis
Actual Study Start Date : March 1, 2022
Actual Primary Completion Date : June 1, 2022
Actual Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. The investigators hereby aim to answer the question whether COVID-19 affects the progression of clinical disability in MS [ Time Frame: 2 years ]
    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.

Secondary Outcome Measures :
  1. vaccination status and progression MS [ Time Frame: 2 years ]
    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).

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
MS patients with Covid 19 infection

Inclusion Criteria:

diagnosis of Multiple Sclerosis Covid 19 infection with PCR test

Exclusion Criteria:

other diagnosis than Multiple Sclerosis

Information from the National Library of Medicine

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): NCT05403463

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Nationaal MS center
Melsbroek, Vlaams Brabant, Belgium, 1820
Sponsors and Collaborators
Marie D'hooghe
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Responsible Party: Marie D'hooghe, neuroloog, National MS Center Melsbroek
ClinicalTrials.gov Identifier: NCT05403463    
Other Study ID Numbers: TofComs
First Posted: June 3, 2022    Key Record Dates
Last Update Posted: June 8, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Disease Progression
Pneumonia, Viral
Respiratory Tract Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Disease Attributes