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.

Completed

• Conditions: Multiple Sclerosis; COVID-19 (Severe Coronavirus Disease 2019)

• Registration Number: NCT04760990
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-17
• Study First Posted: 2021-02-18
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1181

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of severe COVID-19 as defined by the WHO clinical progression scale (Score 6-9)	through study completion, an average of 3 years	Incidence of severe COVID-19 as defined by the WHO clinical progression scale (Score 6-9). The WHO clinical progression scale provides a measure of illness severity across a range from 0 (not infected) to 10 (dead). Incidence of severe COVID-19 infections will be assessed by evaluation of collected data on confirmed SARS-CoV-2-infections and their clinical courses.
COVID-19 related death defined by the WHO clinical progression scale (Score 10)	through study completion, an average of 3 years	COVID-19 related death defined by the WHO clinical progression scale (Score 10) in untreated and treated patients. The WHO clinical progression scale provides a measure of illness severity across a range from 0 (not infected) to 10 (dead).

Secondary Outcome Measures

Name	Time	Method
Proportion of total confirmed SARS-CoV-2-infections (independent of WHO clinical progression scale Score).	through study completion, an average of 3 years	Proportion of total confirmed SARS-CoV-2-infections (independent of WHO clinical progression scale Score).
Change in mean titers of IgM- and IgG-antibodies against SARS-CoV-2	through study completion, an average of 3 years	The Anti-SARS-CoV-2 titer ratios from baseline-samples at pre-pandemic time point to the sample titers during study period will be compared.
Proportion of patients with Anti-SARS-CoV-2 seroconversion	through study completion, an average of 3 years	Proportion of patients with Anti-SARS-CoV-2 seroconversion
Change in individual titers of IgM- and IgG-antibodies against SARS-CoV-2	through study completion, an average of 3 years	The Anti-SARS-CoV-2 titer ratios from baseline-samples at pre-pandemic time point to the sample titers during study period will be compared.

Trial Locations

Locations (7)

Kantonsspital Aarau; 🇨🇭 Aarau, Switzerland

University Hospital Basel, Department of Neurology and Department of Biomedicine; 🇨🇭 Basel, Switzerland

Inselspital Bern; 🇨🇭 Bern, Switzerland

Hôpitaux Universitaires Genève; 🇨🇭 Genève, Switzerland

Lausanne University Hospital (CHUV); 🇨🇭 Lausanne, Switzerland

Ospedale Regionale di Lugano; 🇨🇭 Lugano, Switzerland

Kantonsspital St. Gallen; 🇨🇭 St. Gallen, Switzerland