<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/NCT04459689</url>
  </required_header>
  <id_info>
    <org_study_id>COPID19</org_study_id>
    <nct_id>NCT04459689</nct_id>
  </id_info>
  <brief_title>COVID-19 in PID Survey</brief_title>
  <acronym>COPID19</acronym>
  <official_title>Worldwide COVID-19 in Children and Adult Patients With Primary ImmunoDeficiencies (PID) Survey</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imagine Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imagine Institute</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>
      With the emergence of SARS-CoV-2 and the COVID-19 pandemic, there is an urgent need to&#xD;
      understand the impact of infection on immunodeficient individuals. Whilst co-morbidities&#xD;
      (such as diabetes, cancer, arterial hypertension, heart disease...) have been documented in&#xD;
      people infected with SARS-CoV-2, there is currently no information on the consequences and&#xD;
      outcomes for individuals with primary immunodeficiencies (PID).&#xD;
&#xD;
      Following the 1st phase of the survey (launched by Isabelle Meyts (ESID), Nizar Mahlaoui&#xD;
      (CEREDIH &amp; IPOPI) and Kate Sullivan with Stuart Tangye (IUIS), that gave an idea of the&#xD;
      number of affected PID patients and the impact of SARS-CoV-2 and directly focusing on&#xD;
      obtaining this top level of information), we are launching the 2nd phase: &quot;COPID19&quot;.&#xD;
&#xD;
      COPID19 survey is a secured online GDPR compliant platform based in Paris (Imagine&#xD;
      Institute). It has been approved by the Paris-Necker-Enfants malades IRB and Ethics&#xD;
      Committee. However, this retrospective survey is designed for global distribution. Data can&#xD;
      be entered by a health care professional (mostly clinicians) through a personal login and&#xD;
      password.&#xD;
&#xD;
      Each documenting person will have access to his/her own patients' data. COPID19 require a&#xD;
      greater level of information than the 1st phase. The eCRF will be open to evolutions&#xD;
      depending on progresses in our knowledge of this pandemic.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 15, 2020</start_date>
  <completion_date type="Anticipated">March 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Survival of patients with PID affected by COVID-19</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of admission to ICU of patients with PID affected by COVID-19</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of oxygen therapy of patients with PID affected by COVID-19</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sequelae of patients with PID affected by COVID-19</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Primary Immune Deficiency</condition>
  <condition>COVID</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with Primary Immune Deficiency and COVID-19&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with a Primary Immune Deficiency&#xD;
&#xD;
          -  COVID-19 (proven or probable)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Secondary Immune Deficiency&#xD;
&#xD;
          -  Other Coronovirus infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Nizar MAHLAOUI, MD, MPH, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Necker Enfants Malades University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nizar MAHLAOUI, MD, MPH, PhD</last_name>
    <phone>+33144494622</phone>
    <email>nizar.mahlaoui@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hassan FAOUR, BS</last_name>
    <phone>+33 1 42 75 44 73</phone>
    <email>supportdatabase@institutimagine.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Imagine Institute</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nizar MAHLAOUI, MD, MPH, PhD</last_name>
      <phone>+33144494622</phone>
      <email>nizar.mahlaoui@aphp.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>https://dsp.institutimagine.org/copid/connexion.php</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>September 1, 2021</last_update_submitted>
  <last_update_submitted_qc>September 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Primary Immunodeficiency Diseases</mesh_term>
    <mesh_term>Immunologic Deficiency Syndromes</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/NCT04459689
org study id: COPID19
nct id: NCT04459689
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
With the emergence of SARS-CoV-2 and the COVID-19 pandemic, there is an urgent need to
      understand the impact of infection on immunodeficient individuals. Whilst co-morbidities
      (such as diabetes, cancer, arterial hypertension, heart disease...) have been documented in
      people infected with SARS-CoV-2, there is currently no information on the consequences and
      outcomes for individuals with primary immunodeficiencies (PID).

      Following the 1st phase of the survey (launched by Isabelle Meyts (ESID), Nizar Mahlaoui
      (CEREDIH & IPOPI) and Kate Sullivan with Stuart Tangye (IUIS), that gave an idea of the
      number of affected PID patients and the impact of SARS-CoV-2 and directly focusing on
      obtaining this top level of information), we are launching the 2nd phase: "COPID19".

      COPID19 survey is a secured online GDPR compliant platform based in Paris (Imagine
      Institute). It has been approved by the Paris-Necker-Enfants malades IRB and Ethics
      Committee. However, this retrospective survey is designed for global distribution. Data can
      be entered by a health care professional (mostly clinicians) through a personal login and
      password.

      Each documenting person will have access to his/her own patients' data. COPID19 require a
      greater level of information than the 1st phase. The eCRF will be open to evolutions
      depending on progresses in our knowledge of this pandemic.
observational model: Case-Only
time perspective: Prospective
measure: Survival of patients with PID affected by COVID-19
time frame: Baseline
measure: Rate of admission to ICU of patients with PID affected by COVID-19
time frame: Baseline
measure: Rate of oxygen therapy of patients with PID affected by COVID-19
time frame: Baseline
measure: Sequelae of patients with PID affected by COVID-19
time frame: Baseline
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 0 Years
maximum age: N/A
last name: Nizar MAHLAOUI, MD, MPH, PhD
role: Study Chair
affiliation: Necker Enfants Malades University Hospital
last name: Nizar MAHLAOUI, MD, MPH, PhD
phone: +33144494622
email: nizar.mahlaoui@aphp.fr
last name: Hassan FAOUR, BS
phone: +33 1 42 75 44 73
email: supportdatabase@institutimagine.org
facility: 
status: Recruiting
contact: 
country: France
url: https://dsp.institutimagine.org/copid/connexion.php
description: Related Info
responsible party type: Sponsor
mesh term: Primary Immunodeficiency Diseases
mesh term: Immunologic Deficiency Syndromes
sharing ipd: No