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

NCT ID: NCT05403463

Last Updated: 2022-06-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 230 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-06-01

Brief Summary

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

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).

Conditions

COVID-19

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

diagnosis of Multiple Sclerosis Covid 19 infection with PCR test

Exclusion Criteria

other diagnosis than Multiple Sclerosis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marie D'hooghe

OTHER

Sponsor Role: lead

Responsible Party

Marie D'hooghe

neuroloog

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Nationaal MS center

Melsbroek, Vlaams Brabant, Belgium

Countries

Belgium

References

Peeters G, Van Remoortel A, Nagels G, Van Schependom J, D'haeseleer M. Occurrence and Severity of Coronavirus Disease 2019 Are Associated With Clinical Disability Worsening in Patients With Multiple Sclerosis. Neurol Neuroimmunol Neuroinflamm. 2023 Feb 17;10(3):e200089. doi: 10.1212/NXI.0000000000200089. Print 2023 May.

Reference Type: DERIVED

PMID: 36807080 (View on PubMed)

Other Identifiers

TofComs

Identifier Type: -

Identifier Source: org_study_id