A multicenter, prospective cohort study to document the immunization status of MS patients in Germany with focus on anti-SARS-CoV-2 vaccination response (COVID-19)
- Conditions
- G35Multiple sclerosis
- Registration Number
- DRKS00025893
- Lead Sponsor
- Biogen GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
1. Male or female patients of at least 18 years of age at time of informed consent
2. Diagnosis of MS according to McDonald criteria (2018)
3. Ability to understand the purpose of the study and provide signed and dated study-specific informed consent form (ICF)
4. SARS-CoV-2 vaccination is planned (within the upcoming 90 days), underway (only one of two vaccinations received) or only recently completed (in the last 6 weeks).
or
SARS-CoV-2 vaccination has been completed > 6 weeks but an additional vaccination is planned within the upcoming 90 days.
5. In case of prior SARS-CoV-2 infection(s), patient has recovered from infection.
1. Patient cannot be regularly followed up for organizational or geographic reasons.
2. Patient is unwilling to get vaccinated against SARS COV-2 virus.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber and proportion of patients who developed an immune response to their last SARS-Cov-2-vaccination at visit 2 (about 30 days after the last vaccination)
- Secondary Outcome Measures
Name Time Method Change of SARS-CoV-2 Spike IgA levels, Spike IgG, and NCP IgG levels; Number and proportion of patients who retained an immune response to their last SARS-CoV-2-vaccination at visit 1 (if applicable) and visit 3; Number and proportion of patients who developed an immune response to their SARS-CoV-2-vaccination at visit 1 (if applicable), visit 2 and visit 3 per vaccination cycle ; Number and proportion of patients by applied SARS-CoV-2 vaccine and vaccination cycle; Number and proportion of patients per vaccination cycle; Number and proportion of patients assessing the tolerability of the applied vaccine according to the predefined categories.<br>