Official Title
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.
Brief Summary

This nested project of the Swiss Multiple Sclerosis Cohort (SMSC) is to assess theseverity of COVID-19 and the magnitude of antibody response after infection with SevereAcute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in patients already treated or notwith various immunotherapies for multiple sclerosis followed in the framework of theSMSC.

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.

Unknown status
Multiple Sclerosis
COVID-19 (Severe Coronavirus Disease 2019)

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.

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Switzerland
Locations

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

Contacts

Matthias Mehling, PD Dr. med.
+41 61 328 77 40
matthias.mehling@usb.ch

Jens Kuhle, Prof. Dr. med.
+41 61 328 71 91
jens.kuhle@usb.ch

Matthias Mehling, PD Dr. med., Principal Investigator
University of Basel, Department of Biomedicine and University Hospital Basel

Swiss Multiple Sclerosis Registry
NCT Number
Keywords
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Swiss Multiple Sclerosis Cohort (SMSC)
MeSH Terms
COVID-19
Coronavirus Infections
Multiple Sclerosis
Sclerosis