COVID-19 and SARS-CoV-2 Antibodies in Multiple Sclerosis Patients

Multiple Sclerosis Clinical Trial

— COMS-19  

Official title:

COVID-19 and SARS-CoV-2 Antibodies in Multiple Sclerosis Patients: a Large Study in the Amsterdam MS Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04498286
• Other study ID #: NL74243.029.20
• Status: Completed
• Start date: August 8, 2020
• Est. completion date: October 31, 2021

Study information

• Verified date: January 2023
• Source: Amsterdam UMC, location VUmc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Rationale: Patients with MS are possibly more vulnerable to infection with SARS-CoV-2. Furthermore the use of immunomodulatory treatment could have an effect on the course of COVID-19 disease. This has resulted in an alteration of current immunomodulatory treatment strategies and delaying the start of certain medications, which could induce MS disease activity. However, certain immunomodulatory treatments are also hypothesized to have a positive effect on COVID-19 disease. Besides lack of information regarding the effects of MS treatments on COVID-19, there is significant uncertainty in how we should advise MS patients in terms of self-isolation, resulting in many patients staying at home reluctant to perform their work or other daily activities. Nationally and locally, we are collecting information regarding COVID-19 in MS patients but numbers are low and only those who are severely affected are tested. Furthermore, there is no information regarding SARS-CoV-2 immunity in MS patients, which could be affected by certain MS treatments. Consequently, there is an urgent need for reliable information about infection rates/immunity and course of COVID-19 in relation to MS characteristics and treatments.

Objectives: 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 and 2. to study the proportion of MS patients with SARS-CoV-2 antibodies 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: This is a mono-center cohort study in patients of the MS Center Amsterdam.

Study population: All patients with a diagnosis of MS currently under follow-up in the Amsterdam MS Center.

Intervention (if applicable): Single venous puncture for drawing blood and questionnaire. For a minority of patients (max 25%) who test positive for antibodies we will draw blood a again with questionnaires after six and twelve months.

Main study parameters/endpoints: Course of COVID-19 in MS patients in relation to MS immunomodulatory treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 546
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• a current diagnosis of multiple sclerosis and age =18 years.

Exclusion Criteria:

• lack of informed consent.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Diagnostic Test:
• Testing of SARS-CoV-2 antibodies
Sars-CoV-2 RBD total antibody test developed by Sanquin

Locations

Country	Name	City	State
Netherlands	VU medical center	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Zoé van Kempen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The correlation of COVID-19 disease course with MS immunomodulatory treatment	Correlationg of disease course of COVID-19 in patients with positive SARS-CoV-2 antibodies defined by questionnaires (asymptomatic, mild symptoms, severe symptoms, hospitalization) with MS immunomodulatory treatment (asked by questionnaires)	at baseline questionnaires and lab results