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.

NCT04760990 | Completed

• 1 other identifier: 2020-02604; me20Mehling
• Study Type: observational
• Target: 1,181
• Locations: 1 country
• Sites: 7

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.

Conditions

Multiple Sclerosis; COVID-19 (Severe Coronavirus Disease 2019)

Keywords

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2); Swiss Multiple Sclerosis Cohort (SMSC)

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• 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

  through study completion, an average of 3 years

• Change in individual titers of IgM- and IgG-antibodies against SARS-CoV-2

  through study completion, an average of 3 years

• Proportion of total confirmed SARS-CoV-2-infections (independent of WHO clinical progression scale Score).

  through study completion, an average of 3 years

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• all patients in the Swiss Multiple Sclerosis Cohort (SMSC)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Swiss Multiple Sclerosis Registry: collaborator

Study Sites (7)

Kantonsspital Aarau

Aarau, 5001, Switzerland

Location

University Hospital Basel, Department of Neurology and Department of Biomedicine

Basel, 4031, Switzerland

Location

Inselspital Bern

Bern, 3010, Switzerland

Location

Hôpitaux Universitaires Genève

Geneva, 1205, Switzerland

Location

Lausanne University Hospital (CHUV)

Lausanne, 1011, Switzerland

Location

Ospedale Regionale di Lugano

Lugano, 6903, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

MeSH Terms

Conditions

Multiple Sclerosis; COVID-19

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Matthias Mehling, PD Dr. med.

  University of Basel, Department of Biomedicine and University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 18, 2021
• Study Start: February 1, 2021
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: April 23, 2025

Record last verified: 2025-04

Locations

CH (7)