NCT04498286: COMS-19

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

Completed Last updated 4 January 2023

What this trial tests

trial testing Testing of SARS-CoV-2 antibodies in Multiple Sclerosis in 546 participants. Completed in 31 October 2021.

Timeline

8 August 2020

Primary endpoint
31 October 2021

31 October 2021

Quick facts

Lead sponsor	Zoé van Kempen
Status	Completed
Study type	OBSERVATIONAL
Enrollment	546
Start date	8 August 2020
Primary completion	31 October 2021
Estimated completion	31 October 2021
Sites	1 location across Netherlands

Drugs / interventions tested

• Testing of SARS-CoV-2 antibodies

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

Zoé van Kempen

Who can join

18 and older, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antibody development after COVID-19 vaccination in patients with autoimmune diseases in the Netherlands: a substudy of data from two prospective cohort studies.
   Boekel L, Steenhuis M, Hooijberg F, Besten YR, et al · · 2021 · cited 133× · PMID 34396154 · DOI 10.1016/s2665-9913(21)00222-8
2. Perspective of patients with autoimmune diseases on COVID-19 vaccination.
   Boekel L, Hooijberg F, van Kempen ZLE, Vogelzang EH, et al · · 2021 · cited 68× · PMID 33655220 · DOI 10.1016/s2665-9913(21)00037-0
3. Adverse events after first COVID-19 vaccination in patients with autoimmune diseases.
   Boekel L, Kummer LY, van Dam KPJ, Hooijberg F, et al · · 2021 · cited 55× · PMID 34179831 · DOI 10.1016/s2665-9913(21)00181-8
4. Longitudinal SARS-CoV-2 humoral response in MS patients with and without SARS-CoV-2 infection prior to vaccination.
   van Dam KPJ, Hogenboom L, Stalman EW, Kummer LYL, et al · · 2022 · cited 5× · PMID 36438945 · DOI 10.3389/fneur.2022.1032830