Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05834335
Other study ID # 01042023
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date April 1, 2023

Study information

Verified date November 2023
Source National MS Center Melsbroek
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date April 1, 2023
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - diagnosis of multiple sclerosis - positive selftest or PCR test Coronavirus Exclusion Criteria: - none

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Belgium Nationaal MS center Melsbroek Vlaams Brabant

Sponsors (1)

Lead Sponsor Collaborator
National MS Center Melsbroek

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 year
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 NCT02845635 - MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis