<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04498286</url>
  </required_header>
  <id_info>
    <org_study_id>NL74243.029.20</org_study_id>
    <nct_id>NCT04498286</nct_id>
  </id_info>
  <brief_title>COVID-19 and SARS-CoV-2 Antibodies in Multiple Sclerosis Patients</brief_title>
  <acronym>COMS-19</acronym>
  <official_title>COVID-19 and SARS-CoV-2 Antibodies in Multiple Sclerosis Patients: a Large Study in the Amsterdam MS Cohort</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zoé van Kempen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amsterdam UMC, location VUmc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rationale: Patients with MS are possibly more vulnerable to infection with SARS-CoV-2.&#xD;
      Furthermore the use of immunomodulatory treatment could have an effect on the course of&#xD;
      COVID-19 disease. This has resulted in an alteration of current immunomodulatory treatment&#xD;
      strategies and delaying the start of certain medications, which could induce MS disease&#xD;
      activity. However, certain immunomodulatory treatments are also hypothesized to have a&#xD;
      positive effect on COVID-19 disease. Besides lack of information regarding the effects of MS&#xD;
      treatments on COVID-19, there is significant uncertainty in how we should advise MS patients&#xD;
      in terms of self-isolation, resulting in many patients staying at home reluctant to perform&#xD;
      their work or other daily activities. Nationally and locally, we are collecting information&#xD;
      regarding COVID-19 in MS patients but numbers are low and only those who are severely&#xD;
      affected are tested. Furthermore, there is no information regarding SARS-CoV-2 immunity in MS&#xD;
      patients, which could be affected by certain MS treatments. Consequently, there is an urgent&#xD;
      need for reliable information about infection rates/immunity and course of COVID-19 in&#xD;
      relation to MS characteristics and treatments.&#xD;
&#xD;
      Objectives: The objectives of this study are 1. to study the course of COVID-19 in MS&#xD;
      patients in relation to immunomodulatory treatment and other patient and MS characteristics&#xD;
      and 2. to study the proportion of MS patients with SARS-CoV-2 antibodies and 3. to establish&#xD;
      the antibody profile in positive tested patients and 4. to study the longitudinal course of&#xD;
      these antibody profiles in positive tested patients.&#xD;
&#xD;
      Study design: This is a mono-center cohort study in patients of the MS Center Amsterdam.&#xD;
&#xD;
      Study population: All patients with a diagnosis of MS currently under follow-up in the&#xD;
      Amsterdam MS Center.&#xD;
&#xD;
      Intervention (if applicable): Single venous puncture for drawing blood and questionnaire. For&#xD;
      a minority of patients (max 25%) who test positive for antibodies we will draw blood a again&#xD;
      with questionnaires after six and twelve months.&#xD;
&#xD;
      Main study parameters/endpoints: Course of COVID-19 in MS patients in relation to MS&#xD;
      immunomodulatory treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 8, 2020</start_date>
  <completion_date type="Actual">October 31, 2021</completion_date>
  <primary_completion_date type="Actual">October 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The correlation of COVID-19 disease course with MS immunomodulatory treatment</measure>
    <time_frame>at baseline questionnaires and lab results</time_frame>
    <description>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)</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">546</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Amsterdam MS Cohort</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Testing of SARS-CoV-2 antibodies</intervention_name>
    <description>Sars-CoV-2 RBD total antibody test developed by Sanquin</description>
    <arm_group_label>Amsterdam MS Cohort</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with a diagnosis of MS currently under follow-up in the MS Center Amsterdam.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a current diagnosis of multiple sclerosis and age ≥18 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  lack of informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zoé L van Kempen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Amsterdam UMC, location VUmc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VU medical center</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>January 2, 2023</last_update_submitted>
  <last_update_submitted_qc>January 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Amsterdam UMC, location VUmc</investigator_affiliation>
    <investigator_full_name>Zoé van Kempen</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04498286
org study id: NL74243.029.20
nct id: NCT04498286
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Prospective
measure: The correlation of COVID-19 disease course with MS immunomodulatory treatment
time frame: at baseline questionnaires and lab results
description: 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)
arm group label: Amsterdam MS Cohort
intervention type: Diagnostic Test
intervention name: Testing of SARS-CoV-2 antibodies
description: Sars-CoV-2 RBD total antibody test developed by Sanquin
arm group label: Amsterdam MS Cohort
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zoé L van Kempen
role: Principal Investigator
affiliation: Amsterdam UMC, location VUmc
facility: 
country: Netherlands
responsible party type: Sponsor-Investigator
investigator affiliation: Amsterdam UMC, location VUmc
investigator full name: Zoé van Kempen
investigator title: PhD
mesh term: Multiple Sclerosis
mesh term: Sclerosis
mesh term: Antibodies
sharing ipd: Undecided