Multiple SclerosisMS COVID-19NCT04760990
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.
An observational study of Multiple Sclerosis and COVID-19 (Severe Coronavirus Disease 2019), run by University Hospital, Basel, Switzerland at 7 sites in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, COVID-19 (Severe Coronavirus Disease 2019)
- What is being tested?
- data collection and analysis of blood samples
- Type of treatment
- Vaccines
- How many people
- 1,181 participants
- Where
- 7 sitesSwitzerland
- Study dates
- 1 Feb 2021to 15 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- all patients in the Swiss Multiple Sclerosis Cohort (SMSC)
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Switzerland7 sites
Kantonsspital Aarau
Aarau, 5001
University Hospital Basel, Department of Neurology and Department of Biomedicine
Basel, 4031
Inselspital Bern
Bern, 3010
Hôpitaux Universitaires Genève
Geneva, 1205
Lausanne University Hospital (CHUV)
Lausanne, 1011
Ospedale Regionale di Lugano
Lugano, 6903
Kantonsspital St. Gallen
Sankt Gallen, 9007
About this study
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.
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.
Read the 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.
- Being tested
- data collection, analysis of blood samples
- Keywords
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Swiss Multiple Sclerosis Cohort (SMSC)
- Medical subject headings
- Multiple Sclerosis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
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 samplesOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: through study completion, an average of 3 years
Secondary outcomes (4)
Proportion of patients with Anti-SARS-CoV-2 seroconversion
Proportion of patients with Anti-SARS-CoV-2 seroconversion
Measured: through study completion, an average of 3 years
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.
Measured: through study completion, an average of 3 years
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.
Measured: through study completion, an average of 3 years
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).
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Feb 2021
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,181 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Multiple Sclerosis Registry
- Responsible party
- Sponsor
- Investigators
- Matthias Mehling, PD Dr. med., Principal investigator, University of Basel, Department of Biomedicine and University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760990
- Sponsor's protocol ID
- 2020-02604; me20Mehling
- Acronym
- MS COVID-19
- Status last verified
- Apr 2025
- First submitted
- 17 Feb 2021
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04760990
- Acronym / sponsor ID
- MS COVID-19 / 2020-02604; me20Mehling
- Keywords
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Swiss Multiple Sclerosis Cohort (SMSC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,181 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Swiss Multiple Sclerosis Registry
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- all patients in the Swiss Multiple Sclerosis Cohort (SMSC)
Key exclusion criteria (2 listed)
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| data collectionclinical 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 samplesanalysis 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. | Other | – |
Primary outcome
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.
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).
4 secondary outcomes
Proportion of patients with Anti-SARS-CoV-2 seroconversion
Time frame: 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
Change in individual titers of IgM- and IgG-antibodies against SARS-CoV-2
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).
Time frame: through study completion, an average of 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Mehling, PD Dr. med. principal investigator
University of Basel, Department of Biomedicine and University Hospital Basel
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and COVID-19 (Severe Coronavirus Disease 2019), run by University Hospital, Basel, Switzerland at 7 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.