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.

An Open-label Observation 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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04760990

Acronym

MS COVID-19

Enrollment

1181

Registered

2021-02-18

Start date

2021-02-01

Completion date

2023-12-15

Last updated

2025-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 (Severe Coronavirus Disease 2019), Multiple Sclerosis

Keywords

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Swiss Multiple Sclerosis Cohort (SMSC)

Brief summary

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.

Interventions

OTHERdata 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.

OTHERanalysis 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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.
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.
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).

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026