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. (MS COVID-19)

April 11, 2022 updated by: University Hospital, Basel, Switzerland

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

1400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Jens Kuhle, Prof. Dr. med.
  • Phone Number: +41 61 328 71 91
  • Email: jens.kuhle@usb.ch

Study Locations

  • Switzerland
      • Aarau, Switzerland, 5001
      • Basel, Switzerland, 4031
        • Recruiting
        • University Hospital Basel, Department of Neurology and Department of Biomedicine
        • Contact:
        • Sub-Investigator:
          • Jens Kuhle, Prof. Dr. med.
      • Bern, Switzerland, 3010
        • Not yet recruiting
        • Inselspital Bern
        • Contact:
          • Anke Salmen, PD Dr. med.
      • Genève, Switzerland, 1205
        • Recruiting
        • Hôpitaux Universitaires Genève
        • Contact:
        • Sub-Investigator:
          • Gautier Breville
      • Lausanne, Switzerland, 1011
      • Lugano, Switzerland, 6903
        • Recruiting
        • Ospedale Regionale di Lugano
        • Contact:
      • St. Gallen, Switzerland, 9007

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of severe COVID-19 as defined by the WHO clinical progression scale (Score 6-9)
Time Frame: through study completion, an average of 3 years
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)
Time Frame: through study completion, an average of 3 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with Anti-SARS-CoV-2 seroconversion
Time Frame: through study completion, an average of 3 years
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
Time Frame: through study completion, an average of 3 years
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
Time Frame: through study completion, an average of 3 years
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).
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Swiss Multiple Sclerosis Registry

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2021

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

February 17, 2021

First Submitted That Met QC Criteria

February 17, 2021

First Posted (ACTUAL)

February 18, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2022

Last Update Submitted That Met QC Criteria

April 11, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-02604; me20Mehling

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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