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

NCT04498286 | Completed

• 1 other identifier: NL74243.029.20
• Study Type: observational
• Target: 546
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Amsterdam MS Cohort

Diagnostic Test: Testing of SARS-CoV-2 antibodies

Interventions

Testing of SARS-CoV-2 antibodies DIAGNOSTIC_TEST

Sars-CoV-2 RBD total antibody test developed by Sanquin

Amsterdam MS Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• lack of informed consent.

Sponsors & Collaborators

• Zoé van Kempen: lead

Study Sites (1)

VU medical center

Amsterdam, Netherlands

Location

Related Publications (1)

• Boekel L, Steenhuis M, Hooijberg F, Besten YR, van Kempen ZLE, Kummer LY, van Dam KPJ, Stalman EW, Vogelzang EH, Cristianawati O, Keijzer S, Vidarsson G, Voskuyl AE, Wieske L, Eftimov F, van Vollenhoven R, Kuijpers TW, van Ham SM, Tas SW, Killestein J, Boers M, Nurmohamed MT, Rispens T, Wolbink G. Antibody development after COVID-19 vaccination in patients with autoimmune diseases in the Netherlands: a substudy of data from two prospective cohort studies. Lancet Rheumatol. 2021 Nov;3(11):e778-e788. doi: 10.1016/S2665-9913(21)00222-8. Epub 2021 Aug 6.

  PMID: 34396154 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Zoé L van Kempen

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 4, 2020
• Study Start: August 8, 2020
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: January 4, 2023

Record last verified: 2023-01

Locations

NL (1)