<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/NCT04448743</url>
  </required_header>
  <id_info>
    <org_study_id>7829</org_study_id>
    <nct_id>NCT04448743</nct_id>
  </id_info>
  <brief_title>Role of Microparticles in Covid-19 Infection</brief_title>
  <acronym>MICO</acronym>
  <official_title>Role of Circulating Microparticles in Covid-19 Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</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>
      Among the distinctive features of Covid-19, numerous reports have stressed the importance of&#xD;
      vascular damages associated with coagulopathy onset. Microparticles (MPs) shed by&#xD;
      apoptotic/stimulated cells are reliable markers of vascular damage released upon&#xD;
      pro-inflammatory conditions and behave as active participants in the early steps of clot&#xD;
      formation. In addition, MPs carry ACE1 and ACE2, the cell-entry receptor for SARS-Cov2 in the&#xD;
      vasculature and up-regulate ACE1 expression in neighbouring endothelial cells. This may&#xD;
      contribute to unopposed angiotensin II accumulation which further exacerbate tissue injury&#xD;
      and promote both inflammation and thrombosis. The aim of the study is to evaluate the impact&#xD;
      of circulating MPs on ACE2 expression, the cell-entry receptor for SARS-Cov2 on endothelial&#xD;
      cells.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Circulating MPs will be isolated from Covid-19 patients with lupus anticoagulant, from&#xD;
      coronary artery diseases patients and from healthy volunteers without cardiovascular risk&#xD;
      factors. Quantification of MPs will be realized by prothrombinase assay. Primary endothelial&#xD;
      cells (ECs) from porcine coronary artery or porcine pulmonary artery will be isolated and&#xD;
      cultured. ECs will be exposed to circulating MPs. Phenotypical changes (ACE2 expression,&#xD;
      cytoadhesins, cytokines, tissue factor expression) of ECs will be examined. Susceptibility of&#xD;
      ECs to SARS-COV-2 infection will be determined.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2, 2020</start_date>
  <completion_date type="Actual">October 4, 2021</completion_date>
  <primary_completion_date type="Actual">October 4, 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>Western blot measurement of ACE2 receptor expression in porcine cells</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">189</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Covid-19 patients</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>patients with coronary artery disease</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy volunteers</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood sample</intervention_name>
    <description>20 Ml blood sample</description>
    <arm_group_label>Covid-19 patients</arm_group_label>
    <arm_group_label>healthy volunteers</arm_group_label>
    <arm_group_label>patients with coronary artery disease</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        -  Covid-19 patients&#xD;
&#xD;
          -  patients with coronary artery disease&#xD;
&#xD;
          -  healthy volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COVID-19 patients: age &gt; 18 yr&#xD;
&#xD;
          -  SARS-COV-2 infection within 12 months and positive lupus anticoagulant&#xD;
&#xD;
          -  Patients with cardiovascular risk factors: at least among&#xD;
&#xD;
          -  Hypertension, Dyslipidemia, Diabetes mellitus, obesity, smoker, Healthy volunteers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant comorbidities (active cancer, auto-immune diseases…)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Olivier MOREL</name>
      <address>
        <city>Strasbourg</city>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>June 15, 2022</last_update_submitted>
  <last_update_submitted_qc>June 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>microparticles</keyword>
  <keyword>microvesicles</keyword>
  <keyword>vessel</keyword>
  <keyword>vasculature</keyword>
  <keyword>endothelium</keyword>
  <keyword>coagulation</keyword>
  <keyword>thrombosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <!-- 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/NCT04448743
org study id: 7829
nct id: NCT04448743
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Among the distinctive features of Covid-19, numerous reports have stressed the importance of
      vascular damages associated with coagulopathy onset. Microparticles (MPs) shed by
      apoptotic/stimulated cells are reliable markers of vascular damage released upon
      pro-inflammatory conditions and behave as active participants in the early steps of clot
      formation. In addition, MPs carry ACE1 and ACE2, the cell-entry receptor for SARS-Cov2 in the
      vasculature and up-regulate ACE1 expression in neighbouring endothelial cells. This may
      contribute to unopposed angiotensin II accumulation which further exacerbate tissue injury
      and promote both inflammation and thrombosis. The aim of the study is to evaluate the impact
      of circulating MPs on ACE2 expression, the cell-entry receptor for SARS-Cov2 on endothelial
      cells.
Circulating MPs will be isolated from Covid-19 patients with lupus anticoagulant, from
      coronary artery diseases patients and from healthy volunteers without cardiovascular risk
      factors. Quantification of MPs will be realized by prothrombinase assay. Primary endothelial
      cells (ECs) from porcine coronary artery or porcine pulmonary artery will be isolated and
      cultured. ECs will be exposed to circulating MPs. Phenotypical changes (ACE2 expression,
      cytoadhesins, cytokines, tissue factor expression) of ECs will be examined. Susceptibility of
      ECs to SARS-COV-2 infection will be determined.
observational model: Cohort
time perspective: Prospective
measure: Western blot measurement of ACE2 receptor expression in porcine cells
time frame: Through study completion, an average of 1 year
arm group label: Covid-19 patients
arm group label: patients with coronary artery disease
arm group label: healthy volunteers
intervention type: Other
intervention name: Blood sample
description: 20 Ml blood sample
arm group label: Covid-19 patients
arm group label: healthy volunteers
arm group label: patients with coronary artery disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19