NCT Number: NCT04760990
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.
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Notify Me18 year and older
All sexes
Observational
Kantonsspital Aarau, Aarau, Switzerland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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.
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.
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).
Time frame: through study completion, an average of 3 years
Proportion of patients with Anti-SARS-CoV-2 seroconversion
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.
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.
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).
University Hospital, Basel, Switzerland
Other
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.
Acronym: MS COVID-19
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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