Protection Against Severe Coronavirus Disease 2019 in Patients With Multiple Sclerosis Stratified According to Disease Modifying Treatment (PASCOMS)

November 14, 2023 updated by: Marie D'hooghe, National MS Center Melsbroek

Protection Against Severe Coronavirus Disease 2019 Following in Patients With Multiple Sclerosis Statified According to Disease Modifying Treatment

The investigators will conduct retrospective observational cohort study at the Nationaal Multiple Sclerose Centrum (NMSC) Melsbroek (Belgium), which is a large center specifically focusing on neurological management, multidisciplinary care and/or rehabilitation in patients with MS.

Primary endpoint For each DMT category, as defined above, the proportion of patients with a worse COVID-19 outcome (i.e., hospitalization and/or death) will be compared between those 'protected' versus 'unprotected' by vaccination at the time of SARS-CoV-2 infection. Corrections will be applied for any eventual imbalance in demographics, potentially relevant to COVID-19 outcome, between subgroups that are compared to each other, if indicated/feasible.

Study Overview

Status

Completed

Conditions

Detailed Description

Study design The investigators will conduct retrospective observational cohort study at the Nationaal Multiple Sclerose Centrum (NMSC) Melsbroek (Belgium), which is a large center specifically focusing on neurological management, multidisciplinary care and/or rehabilitation in patients with MS.

General aim To explore the protective effect of COVID-19 vaccination in patients with MS, stratified according to their DMT regimen (specifically isolating those treated with B-cell depleting and S1PR modulating agents), against severe forms of the infection.

Data collection Since March 2020 (i.e., the onset of the first wave of spiking COVID-19 cases in Belgium), clinical information of patients followed at the NMSC Melsbroek has been collected in a local database in case of COVID-19 diagnosis, as confirmed by positive antigen or polymerase chain reaction testing for SARS-CoV-2. The following variables were recorded: patient identification number, date of COVID-19 diagnosis, age, sex, race (White/Caucasian, Black/African-American, Asian, other), known co-morbidities (cerebro- and/or cardiovascular disease, arterial hypertension, smoking, dyslipidemia, diabetes mellitus, obesity), Expanded Disability Status Scale (EDSS) score (based on the most recent medical report prior to the infection), MS disease duration, clinical MS subtype, DMT regimen, COVID-19 severity (ambulatory care versus hospitalization versus death), general vaccination status (non-vaccinated versus fully vaccinated versus fully vaccinated + booster), date of last vaccine administration prior to the infection. On December 1, 2022, our database was locked for the present study and consisted of 450 COVID-19 cases (417 unique patients) with complete data.

Patients will be stratified according to their DMT regimen at the time of COVID-19, generating the following categories: (1) anti-CD20 B-cell depleting agents, (2) S1PR modulating agents, (3) all other forms of DMT, (4) no DMT. In each DMT category, patients will be labelled as either 'protected' or 'unprotected' by vaccination at the time of their SARS-CoV-2 infection. Patients were considered to be 'protected' by vaccination if they were (a) fully vaccinated and (b) tested positive for COVID-19 in the period ranging from 14 days to 6 months after the last administered vaccine dose (which could also be a booster).

If the DMT category at the time of last vaccination differed from that at the time of infection, patients will be excluded from the analyses; pulse corticosteroid treatment < 2 months prior to COVID-19 infection will account as an additional exclusion criterion.

Serum/plasma vitamine D levels, as measured the closest to the COVID-19 infection, if available, will be extracted from the medical record for exploratory purposes.

Primary endpoint For each DMT category, as defined above, the proportion of patients with a worse COVID-19 outcome (i.e., hospitalization and/or death) will be compared between those 'protected' versus 'unprotected' by vaccination at the time of SARS-CoV-2 infection. Corrections will be applied for any eventual imbalance in demographics, potentially relevant to COVID-19 outcome, between subgroups that are compared to each other, if indicated/feasible.

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with multiple sclerosis and a positive selftest or positive PCR test for Corona disease

Description

Inclusion Criteria:

  • diagnosis of multiple sclerosis
  • positive selftest or PCR test Coronavirus

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
For each DMT category the proportion of patients with a worse COVID-19 outcome will be compared between those 'protected' versus 'unprotected' by vaccination at the time of SARS-CoV-2 infection.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National MS Center Melsbroek

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

April 17, 2023

First Submitted That Met QC Criteria

April 17, 2023

First Posted (Actual)

April 28, 2023

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01042023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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