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| Name | Class |
|---|---|
| Swiss Multiple Sclerosis Registry | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| data collection | Other | 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 blood samples | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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This study is a nested project within the framework of the SMSC. The SMSC is a prospective multicenter cohort study performed across eight swiss centres. Patients are recruited in the SMSC according to a set of inclusion criteria as specified in the cohort protocol and are only included after a written informed consent is signed.
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Mehling, PD Dr. med. | University of Basel, Department of Biomedicine and University Hospital Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Aarau | Aarau | 5001 | Switzerland | |||
| University Hospital Basel, Department of Neurology and Department of Biomedicine |
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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 |
| Basel |
| 4031 |
| Switzerland |
| Inselspital Bern | Bern | 3010 | Switzerland |
| Hôpitaux Universitaires Genève | Geneva | 1205 | Switzerland |
| Lausanne University Hospital (CHUV) | Lausanne | 1011 | Switzerland |
| Ospedale Regionale di Lugano | Lugano | 6903 | Switzerland |
| Kantonsspital St. Gallen | Sankt Gallen | 9007 | Switzerland |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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