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.
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 Type
OBSERVATIONAL
Enrollment
1,181
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.
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.
Kantonsspital Aarau
Aarau, Switzerland
University Hospital Basel, Department of Neurology and Department of Biomedicine
Basel, Switzerland
Inselspital Bern
Bern, Switzerland
Hôpitaux Universitaires Genève
Geneva, Switzerland
Lausanne University Hospital (CHUV)
Lausanne, Switzerland
Ospedale Regionale di Lugano
Lugano, Switzerland
Kantonsspital St. Gallen
Sankt Gallen, Switzerland
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.
Time frame: 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).
Time frame: through study completion, an average of 3 years
Proportion of patients with Anti-SARS-CoV-2 seroconversion
Proportion of patients with Anti-SARS-CoV-2 seroconversion
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: through study completion, an average of 3 years
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