Clinical trial NCT04760990: 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.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
COVID-19 (Severe Coronavirus Disease 2019)
Keywords: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Swiss Multiple Sclerosis Cohort (SMSC)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss Multiple Sclerosis Registry
First posted: 2021-02-18
Enrollment: 1181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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: 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.

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

Primary outcomes:
measure: Incidence of severe COVID-19 as defined by the WHO clinical progression scale (Score 6-9)
timeFrame: through study completion, an average of 3 years
measure: COVID-19 related death defined by the WHO clinical progression scale (Score 10)
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
measure: Proportion of patients with Anti-SARS-CoV-2 seroconversion
timeFrame: through study completion, an average of 3 years
measure: Change in mean titers of IgM- and IgG-antibodies against SARS-CoV-2
timeFrame: through study completion, an average of 3 years
measure: Change in individual titers of IgM- and IgG-antibodies against SARS-CoV-2
timeFrame: through study completion, an average of 3 years
measure: Proportion of total confirmed SARS-CoV-2-infections (independent of WHO clinical progression scale Score).
timeFrame: through study completion, an average of 3 years
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Basel
country: Switzerland
facility: University Hospital Basel, Department of Neurology and Department of Biomedicine
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Genève
country: Switzerland
facility: Hôpitaux Universitaires Genève
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital (CHUV)
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
Study officials:
affiliation: University of Basel, Department of Biomedicine and University Hospital Basel
name: Matthias Mehling, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: