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

January 2, 2023 updated by: Zoé van Kempen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

546

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • lack of informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Amsterdam MS Cohort
Diagnostic test: Testing of SARS-CoV-2 antibodies
Sars-CoV-2 RBD total antibody test developed by Sanquin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The correlation of COVID-19 disease course with MS immunomodulatory treatment
Time Frame: at baseline questionnaires and lab results
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zoé van Kempen

Investigators

  • Principal Investigator: Zoé L van Kempen, Amsterdam UMC, location VUmc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2020

Primary Completion (Actual)

October 31, 2021

Study Completion (Actual)

October 31, 2021

Study Registration Dates

First Submitted

August 3, 2020

First Submitted That Met QC Criteria

August 3, 2020

First Posted (Actual)

August 4, 2020

Study Record Updates

Last Update Posted (Actual)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 2, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL74243.029.20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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