<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/NCT04420468</url>
  </required_header>
  <id_info>
    <org_study_id>APHP200632</org_study_id>
    <nct_id>NCT04420468</nct_id>
  </id_info>
  <brief_title>Descriptive and Retrospective Analysis of Acute Myocarditis Associated With Pandemic COVID-19 in Children</brief_title>
  <acronym>HEART-COVID</acronym>
  <official_title>Descriptive and Retrospective Analysis of Acute Myocarditis Associated With Pandemic COVID-19 in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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>
      The study objectives are to descript clinical, biological and echocardiographic features of&#xD;
      an acute myocarditis in children in the context of COVID-19 and to identify the underlying&#xD;
      mechanism : direct viral damage and/or inadequate host response risk.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An unexpected increase of shock with fever in children suspected to be infect by the COVID-19&#xD;
      is observed. These children present with similar symptoms and seem to have similar clinical&#xD;
      time course.&#xD;
&#xD;
      This unexpected phenomenon needs to be extensively described in order to further the&#xD;
      knowledge of unusual COVID-19 presentation in children.&#xD;
&#xD;
      The study consists an extensive retrospective data collection from April 2020 till the end of&#xD;
      the main SARS-Cov-2 outbreak, from medical file of children have exhibited acute myocarditis&#xD;
      and cared in 4 pediatric intensive care units of Assistance Publique-Hôpitaux de Paris of&#xD;
      Ile-de-France region.&#xD;
&#xD;
      The study objectives are to descript clinical, biological and echocardiographic features of&#xD;
      an acute myocarditis in children in the context of COVID-19 and to identify the underlying&#xD;
      mechanism : direct viral damage and/or inadequate host response risk.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 10, 2020</start_date>
  <completion_date type="Anticipated">August 2021</completion_date>
  <primary_completion_date type="Anticipated">August 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Acute myocarditis</measure>
    <time_frame>7 days</time_frame>
    <description>Occurrence, description and time course of acute myocarditis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Multi-systemic inflammatory syndrome</measure>
    <time_frame>7 days</time_frame>
    <description>Occurrence, description and time course of multi-systemic inflammatory syndrome, features of Kawasaki disease</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kawasaki disease</measure>
    <time_frame>7 days</time_frame>
    <description>Occurrence, description and time course of features of Kawasaki disease</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Results of SARS-CoV-2</measure>
    <time_frame>7 days</time_frame>
    <description>Results of SARS-CoV-2 screening either by PCR or antibodies serological assay</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Possible COVID-19 infection and acute myocarditis</arm_group_label>
    <description>Children presented with an acute myocarditis, fever and shock with a possible COVID-19 infection cared between April 2020 till the end of the main SARS-Cov-2 outbreak in 4 AP-HP Parisian hospitals :&#xD;
Necker-Enfants Malades&#xD;
Armand Trousseau&#xD;
Robert Debré&#xD;
Kremlin Bicêtre</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Children presented with an acute myocarditis, fever and shock with a possible COVID-19&#xD;
        infection cared between April 2020 till the end of the main SARS-Cov-2 outbreak in 4 AP-HP&#xD;
        Parisian hospitals :&#xD;
&#xD;
          -  Necker-Enfants Malades&#xD;
&#xD;
          -  Armand Trousseau&#xD;
&#xD;
          -  Robert Debré&#xD;
&#xD;
          -  Kremlin Bicêtre&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Admitted to PICU from April 2020&#xD;
&#xD;
          -  Presented with an acute myocarditis, fever and shock with a possible COVID-19&#xD;
             infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Other etiologies of acute myocarditis than the COVID-19&#xD;
&#xD;
          -  Opposition expressed by the holders of parental authority&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marion Grimaud</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sylvain Renolleau, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marion Grimaud, MD</last_name>
    <phone>1 87 89 20 19</phone>
    <phone_ext>+33</phone_ext>
    <email>marion.grimaud@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hélène Morel</last_name>
    <phone>1 71 19 63 46</phone>
    <phone_ext>+33</phone_ext>
    <email>helene.morel@aphp.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hôpital Bicêtre</name>
      <address>
        <city>Le Kremlin-Bicêtre</city>
        <zip>94270</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clémence Marais, MD</last_name>
      <email>clemence.marais@aphp.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Armand Trousseau</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julie Starck, MD</last_name>
      <email>julie.starck@aphp.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Necker-Enfants Malades</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marion Grimaud, MD</last_name>
      <phone>1 87 89 20 19</phone>
      <phone_ext>+33</phone_ext>
      <email>marion.grimaud@aphp.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Robert Debré</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michäel Levy, MD</last_name>
      <email>michael.levy@aphp.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7266128/</url>
    <description>Published online 2020, PMID: 32488505</description>
  </link>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>May 21, 2021</last_update_submitted>
  <last_update_submitted_qc>May 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Acute myocarditis</keyword>
  <keyword>Children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Myocarditis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04420468
org study id: APHP200632
nct id: NCT04420468
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study objectives are to descript clinical, biological and echocardiographic features of
      an acute myocarditis in children in the context of COVID-19 and to identify the underlying
      mechanism : direct viral damage and/or inadequate host response risk.
An unexpected increase of shock with fever in children suspected to be infect by the COVID-19
      is observed. These children present with similar symptoms and seem to have similar clinical
      time course.

      This unexpected phenomenon needs to be extensively described in order to further the
      knowledge of unusual COVID-19 presentation in children.

      The study consists an extensive retrospective data collection from April 2020 till the end of
      the main SARS-Cov-2 outbreak, from medical file of children have exhibited acute myocarditis
      and cared in 4 pediatric intensive care units of Assistance Publique-Hôpitaux de Paris of
      Ile-de-France region.

      The study objectives are to descript clinical, biological and echocardiographic features of
      an acute myocarditis in children in the context of COVID-19 and to identify the underlying
      mechanism : direct viral damage and/or inadequate host response risk.
observational model: Cohort
time perspective: Retrospective
measure: Acute myocarditis
time frame: 7 days
description: Occurrence, description and time course of acute myocarditis
measure: Multi-systemic inflammatory syndrome
time frame: 7 days
description: Occurrence, description and time course of multi-systemic inflammatory syndrome, features of Kawasaki disease
measure: Kawasaki disease
time frame: 7 days
description: Occurrence, description and time course of features of Kawasaki disease
measure: Results of SARS-CoV-2
time frame: 7 days
description: Results of SARS-CoV-2 screening either by PCR or antibodies serological assay
arm group label: Possible COVID-19 infection and acute myocarditis
description: Children presented with an acute myocarditis, fever and shock with a possible COVID-19 infection cared between April 2020 till the end of the main SARS-Cov-2 outbreak in 4 AP-HP Parisian hospitals :
Necker-Enfants Malades
Armand Trousseau
Robert Debré
Kremlin Bicêtre
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 17 Years
healthy volunteers: No
last name: Marion Grimaud
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
last name: Sylvain Renolleau, MD, PhD
role: Study Director
affiliation: Assistance Publique - Hôpitaux de Paris
last name: Marion Grimaud, MD
phone: 1 87 89 20 19
phone ext: +33
email: marion.grimaud@aphp.fr
last name: Hélène Morel
phone: 1 71 19 63 46
phone ext: +33
email: helene.morel@aphp.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7266128/
description: Published online 2020, PMID: 32488505
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Myocarditis
sharing ipd: No