<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/NCT04412031</url>
  </required_header>
  <id_info>
    <org_study_id>20_185</org_study_id>
    <nct_id>NCT04412031</nct_id>
  </id_info>
  <brief_title>Prediction of Unfavourable Outcome in Newly Covid-19 Hospitalized Patient</brief_title>
  <acronym>PredictCovid19</acronym>
  <official_title>Bayesian Network to Predict Transfer in Intensive Care Units or Death in Newly Covid-19 Hospitalized Patient</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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 project is a part of the &quot;Protocol for a multicentre study of nosocomial SARS-CoV2&#xD;
      transmission: The NOSO-COR Project&quot; registered in ClinicalTrials (NCT04290780).&#xD;
&#xD;
      In the current pandemic context, medical resources have often been exceeded. Developing,&#xD;
      using artificial intelligence techniques, an algorithm capable of detecting patients at risk&#xD;
      of acute respiratory distress following Sars-Cov2 infection could help physicians to optimize&#xD;
      the treatment of patients and health decision-makers to optimize resources. Thus, the goal of&#xD;
      this project is to create a prediction model using artificial intelligence to predict an&#xD;
      unfavorable evolution of Covid-19 at the hospital admission of patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 11, 2019</start_date>
  <completion_date type="Actual">May 15, 2020</completion_date>
  <primary_completion_date type="Actual">May 14, 2020</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>Need of mechanical ventilation, transfer to an intensive care unit or death within 21 days of admission.</measure>
    <time_frame>within 21 days</time_frame>
  </primary_outcome>
  <enrollment type="Actual">802</enrollment>
  <condition>to Predict an Unfavorable Evolution of Covid-19 at the Hospital Admission of Patients</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>non applicable</intervention_name>
    <description>non applicable</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The project is a part of the &quot;Protocol for a multicentre study of nosocomial SARS-CoV2&#xD;
        transmission: The NOSO-COR Project&quot;&#xD;
&#xD;
        It is an international multicentre prospective, observational, hospital-based study in&#xD;
        adults. It will include volunteer patients, care givers and healthcare professionals in&#xD;
        France and hospitals affiliated with the GABRIEL network. Demographic and clinical data&#xD;
        will be collected using case-report forms designed especially for the purpose of the&#xD;
        project. A nasopharyngeal swab will be collected and tested for SARS-CoV2 by RT-PCR.&#xD;
        Characteristics of the study participants, the proportion of confirmed nosocomial SARS-CoV2&#xD;
        infections relative to all patients with syndromes suggestive of 2019-nCoV infection will&#xD;
        be analyzed.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant must be 18 years or older at the time of signing the informed consent&#xD;
&#xD;
          -  Volunteer patients, care givers and healthcare professionals in France and hospitals&#xD;
             affiliated with the GABRIEL network. Demographic and clinical data will be collected&#xD;
             using case-report forms designed especially for the purpose of the project.&#xD;
&#xD;
          -  A nasopharyngeal swab will be collected and tested for SARS-CoV2 by RT-PCR.&#xD;
&#xD;
          -  Admission to hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age lower than 18 years old&#xD;
&#xD;
          -  Patients protected by the law&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hôpital E Herriot - Hospices Civils de LYON</name>
      <address>
        <city>Lyon</city>
        <zip>69437</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</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>COVID-19</mesh_term>
  </condition_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/NCT04412031
org study id: 20_185
nct id: NCT04412031
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The project is a part of the "Protocol for a multicentre study of nosocomial SARS-CoV2
      transmission: The NOSO-COR Project" registered in ClinicalTrials (NCT04290780).

      In the current pandemic context, medical resources have often been exceeded. Developing,
      using artificial intelligence techniques, an algorithm capable of detecting patients at risk
      of acute respiratory distress following Sars-Cov2 infection could help physicians to optimize
      the treatment of patients and health decision-makers to optimize resources. Thus, the goal of
      this project is to create a prediction model using artificial intelligence to predict an
      unfavorable evolution of Covid-19 at the hospital admission of patients
observational model: Cohort
time perspective: Retrospective
measure: Need of mechanical ventilation, transfer to an intensive care unit or death within 21 days of admission.
time frame: within 21 days
intervention type: Other
intervention name: non applicable
description: non applicable
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Undecided