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.

Multiple Sclerosis Clinical Trial

— MS COVID-19  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04760990
• Other study ID #: 2020-02604; me20Mehling
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: December 2023

Study information

• Verified date: April 2022
• Source: University Hospital, Basel, Switzerland
• Contact: Matthias Mehling, PD Dr. med.
• Phone: +41 61 328 77 40
• Email: matthias.mehling[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID-19
• COVID-19 (Severe Coronavirus Disease 2019)
• Multiple Sclerosis
• Sclerosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	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

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Swiss Multiple Sclerosis Registry

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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