A Study to Assess the Potential Impact of Disease Modifying Therapies on COVID-19 Outcomes and the Antibody Response Following an Infection With SARS-CoV-2 in Patients With Multiple Sclerosis Within the Swiss Multiple Sclerosis Cohort.

NCT ID: NCT04760990

Last Updated: 2025-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1181 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2023-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This nested project of the Swiss Multiple Sclerosis Cohort (SMSC) is to assess the severity of COVID-19 and the magnitude of antibody response after infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in patients already treated or not with various immunotherapies for multiple sclerosis followed in the framework of the SMSC.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This nested project of the Swiss Multiple Sclerosis Cohort (SMSC) is to assess the severity of COVID-19 and the magnitude of antibody response after infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in patients already treated or not with various immunotherapies for multiple sclerosis followed in the framework of the SMSC.

To assess the frequency and severity of SARS-CoV-2 infections and associated symptoms in the study population, data is collected from systematic questioning during the SMSC-visits and from serum samples collected every 6-12 months within the SMSC (for measurement of anti-SARS-CoV-2 antibodies in pre-pandemic reference samples and prospectively to determine the anti-SARS-CoV-2-serostatus during the study period).

Combining the information on anti-SARS- CoV-2 serostatus and infection history opens the opportunity to determine the number of patients without or with only mild vs. moderate to severe COVID-19 symptoms in large groups of patients with Multiple Sclerosis (MS) treated with immunotherapies targeting various components of the immune system.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis COVID-19 (Severe Coronavirus Disease 2019)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

data collection

clinical data collection regarding COVID-19 suggestive symptoms or confirmed SARS-CoV-2-infections (medical events), recorded comorbidities (concomitant diseases relevant to MS and COVID-19) and recorded vaccinations (other treatments). This information is systematically collected during the routine clinical visits of the patient within the SMSC every 6-12 months.

Intervention Type OTHER

analysis of blood samples

analysis of archived serum samples collected every 6-12 months within the SMSC for measurement of anti-SARS-CoV-2 antibodies in pre-pandemic reference samples and prospectively determine the anti-SARS-CoV-2-serostatus during the study period.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* all patients in the Swiss Multiple Sclerosis Cohort (SMSC)

Exclusion Criteria

* Patients with Neuromyelitis optica and Radiologically Isolated Syndrome will be excluded
* Existence of a documented refusal of further use of health-related personal data and/or biological material
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Swiss Multiple Sclerosis Registry

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Matthias Mehling, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University of Basel, Department of Biomedicine and University Hospital Basel

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kantonsspital Aarau

Aarau, , Switzerland

Site Status

University Hospital Basel, Department of Neurology and Department of Biomedicine

Basel, , Switzerland

Site Status

Inselspital Bern

Bern, , Switzerland

Site Status

Hôpitaux Universitaires Genève

Geneva, , Switzerland

Site Status

Lausanne University Hospital (CHUV)

Lausanne, , Switzerland

Site Status

Ospedale Regionale di Lugano

Lugano, , Switzerland

Site Status

Kantonsspital St. Gallen

Sankt Gallen, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-02604; me20Mehling

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

ATX-MS-1467 in Multiple Sclerosis
NCT01973491 COMPLETED PHASE2
Immunodeficiency in MS
NCT04447937 UNKNOWN