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.

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

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

Intervention / Treatment
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* Other: data collection
* Other: analysis of blood samples


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: 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.|
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of severe COVID-19 as defined by the WHO clinical progression scale (Score 6-9) | 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. | through study completion, an average of 3 years | 
| COVID-19 related death defined by the WHO clinical progression scale (Score 10) | 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). | through study completion, an average of 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with Anti-SARS-CoV-2 seroconversion | Proportion of patients with Anti-SARS-CoV-2 seroconversion | through study completion, an average of 3 years | 
| Change in mean titers of IgM- and IgG-antibodies against SARS-CoV-2 | 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. | through study completion, an average of 3 years | 
| Change in individual titers of IgM- and IgG-antibodies against SARS-CoV-2 | 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. | through study completion, an average of 3 years | 
| Proportion of total confirmed SARS-CoV-2-infections (independent of WHO clinical progression scale Score). | Proportion of total confirmed SARS-CoV-2-infections (independent of WHO clinical progression scale Score). | through study completion, an average of 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Swiss Multiple Sclerosis Cohort (SMSC)