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COMS-19
Sponsor study identifier
observational
546
1 country
1
Study Start
August 8, 2020
Actual (reported)Primary Completion
October 31, 2021
Actual (reported)Study Completion
October 31, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 31, 2021
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 3, 2020
Actual (reported)August 4, 2020
Actual (reported)August 8, 2020
Actual (reported)October 31, 2021
Actual (reported)October 31, 2021
Actual (reported)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
Sars-CoV-2 RBD total antibody test developed by Sanquin
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
All patients with a diagnosis of MS currently under follow-up in the MS Center Amsterdam.
VU medical center
Amsterdam, Netherlands
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.
Zoé L van Kempen
Amsterdam UMC, location VUmc
546 participants (actual enrollment reported by the registry).
First Submitted
August 3, 2020
First Posted
August 4, 2020
Study Start
August 8, 2020
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
October 31, 2021
Actual (reported)Study Completion
October 31, 2021
Actual (reported)Last Updated
January 4, 2023
Record last verified: 2023-01
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Source: ClinicalTrials.gov.
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