The objectives of this study are 1. to study the course of COVID-19 in MS patients in relation to immunomodulatory treatment and other patient and MS characteristics to study the proportion of MS patients with SARS-CoV-2 antibodies and 2. to study…
ID
Source
Brief title
Condition
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Association of the course of COVID-19 and immunomodulatory treatment.
Secondary outcome
- establishing the percentage of MS patients who have currently developed
SARS-CoV-2 antibodies in the Netherlands.
- In the antibody positive patients we will associate disease course
(asymptomatic, mild symptoms, severe symptoms, hospitalization) with MS
characteristics, demographics and comorbidity.
- Characteristics of patients with SARS-CoV-2 antibodies versus patients
without antibodies in regards to demographics, MS characteristics,
immunomodulatory treatments, prior medical history and degree of social
isolation
- With the Sanquin antibody test, we will study the antibody profile (IgM/G/A,
IgG1/3) and repertoire (anti-SP, anti-NP).
Background summary
The course of COVID-19 in MS patients is still unclear. Patients with MS are
possibly more or less vulnerable to infection with SARS-CoV-2.
Furthermore the use of immunomodulatory treatment and/or MS characteristics
could have an effect on the course of COVID-19 disease.
Study objective
The objectives of this study are 1. to study the course of COVID-19 in MS
patients in relation to immunomodulatory treatment and other patient and MS
characteristics to study the proportion of MS patients with SARS-CoV-2
antibodies and 2. to study the proportion of MS patients with SARS-CoV-2
antibodies to study the course of COVID-19 in MS patients in relation to
immunomodulatory treatment and other patient and MS characteristics and 3. to
establish the antibody profile in positive tested patients and 4. to study the
longitudinal course of these antibody profiles in positive tested patients.
Study design
Phase I is cross sectional with blood testing of antibodies and a questionnaire.
Phase II includes only patients who tested positive in phase one and will be a
longitudinal follow-up at 6 and 12 months with blood testing and a
questionnaire at both time points.
Study burden and risks
All subjects will be asked to complete the online questionnaire one to three
times (approximately 10 minutes) containing questions regarding COVID-19
complaints, medical history and MS characteristics. In addition, blood will be
drawn at VUmc laboratory one to three times.
De Boelelaan 1118
amsterdam 1081 HZ
NL
De Boelelaan 1118
amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
Under current follow-up in the MS Center Amsterdam
Current diagnosis of multiple sclerosis
18 years or older
Exclusion criteria
No informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74243.029.20 |