<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/NCT04422587</url>
  </required_header>
  <id_info>
    <org_study_id>RC31/20/0149</org_study_id>
    <nct_id>NCT04422587</nct_id>
  </id_info>
  <brief_title>Evaluation of the COVID-19 Infection Response in Patients Admitted to the Emergency Department for Dyspnea</brief_title>
  <acronym>EPRICOD</acronym>
  <official_title>Evaluation of the COVID-19 Infection Response in Patients Admitted to the Emergency Department for Dyspnea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</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>
      This research aims to improve our knowledge of the epidemiology of patients consulting in the&#xD;
      COvid-19 Possible REspiratory Units (RECOP unit). Indeed, the epidemic linked to COVID-19&#xD;
      affects France and impacts its health system. The reception of all intermediate patients will&#xD;
      be on the Emergency Structures (SU). Indeed, the French healthcare system centralizes&#xD;
      unscheduled urgent care on the ER. The aspecific respiratory symptomatology in &quot;intermediate&quot;&#xD;
      patients indicates them all the more at an admission to SU or the diagnostic approach to&#xD;
      respiratory difficulty may be carried out.&#xD;
&#xD;
      A central issue of this diagnostic strategy will be to be rapid, since the diagnosis will&#xD;
      have to be made in the context of significant flows, with a need to quickly refer patients to&#xD;
      the most suitable downstream service, while limiting the risk contamination of caregivers and&#xD;
      vulnerable patients if a COVID-19 + patient is admitted to an unsuitable service. However,&#xD;
      virological tests do not currently allow rapid results for COVID-19.&#xD;
&#xD;
      Research project of investigatory aims to develop a predictive model of the risk of being&#xD;
      COVID-19 positive for patients admitted to the emergency room for acute dyspnea.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 13, 2020</start_date>
  <completion_date type="Actual">June 7, 2020</completion_date>
  <primary_completion_date type="Actual">June 5, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>1 Month</target_duration>
  <primary_outcome>
    <measure>Develop a predictive model of the risk of being COVID-19 for patients admitted to the emergency room for dyspnea</measure>
    <time_frame>inclusion day</time_frame>
    <description>demographic variables, usual history and treatments, episode characteristics (symptomatology, evolution, treatment taken) and data from the initial clinical examination will be collected by doctor</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Describe the characteristics of patients admitted to reCOP units according to their virological status</measure>
    <time_frame>30 days</time_frame>
    <description>The COVID-19 virological condition will be taken with PCR tests on naso-pharyngeal samples or on sputum for patients taking</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Virological status</measure>
    <time_frame>30 days</time_frame>
    <description>Virological status will be collected by a phone call at the patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality status</measure>
    <time_frame>30 days</time_frame>
    <description>Mortality status will be collected by a phone call at the patient</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1860</enrollment>
  <condition>Emergencies</condition>
  <arm_group>
    <arm_group_label>RECOP unit patient</arm_group_label>
    <description>All patients admit in RECOP unit for dyspnea can be included in this study if patient is agree. Then, doctor collects demographic variables, the usual history and treatments, the characteristics of the episode (symptomatology, evolution, treatment taken) and the data from the initial clinical examination will be identified.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>RECOP unit patient</intervention_name>
    <description>All patients admit in RECOP unit for dyspnea can be included in this study if patient is agree. Then, doctor collects demographic variables, the usual history and treatments, the characteristics of the episode (symptomatology, evolution, treatment taken) and the data from the initial clinical examination will be identified.</description>
    <arm_group_label>RECOP unit patient</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        all patient admitted to the RECOP unit for dyspnea will be inclued in this clinical trial&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients over 15 years admitted to the RECOP unit for dyspnea&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient admitted to shock for respiratory distress requiring immediate respiratory&#xD;
             support.&#xD;
&#xD;
          -  Patient under justice safeguard&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul-Henri Auboiroux, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of Toulouse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>November 4, 2020</last_update_submitted>
  <last_update_submitted_qc>November 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>diagnostic strategy</keyword>
  <keyword>acute dyspnea</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Dyspnea</mesh_term>
    <mesh_term>Emergencies</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/NCT04422587
org study id: RC31/20/0149
nct id: NCT04422587
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research aims to improve our knowledge of the epidemiology of patients consulting in the
      COvid-19 Possible REspiratory Units (RECOP unit). Indeed, the epidemic linked to COVID-19
      affects France and impacts its health system. The reception of all intermediate patients will
      be on the Emergency Structures (SU). Indeed, the French healthcare system centralizes
      unscheduled urgent care on the ER. The aspecific respiratory symptomatology in "intermediate"
      patients indicates them all the more at an admission to SU or the diagnostic approach to
      respiratory difficulty may be carried out.

      A central issue of this diagnostic strategy will be to be rapid, since the diagnosis will
      have to be made in the context of significant flows, with a need to quickly refer patients to
      the most suitable downstream service, while limiting the risk contamination of caregivers and
      vulnerable patients if a COVID-19 + patient is admitted to an unsuitable service. However,
      virological tests do not currently allow rapid results for COVID-19.

      Research project of investigatory aims to develop a predictive model of the risk of being
      COVID-19 positive for patients admitted to the emergency room for acute dyspnea.
observational model: Cohort
time perspective: Other
measure: Develop a predictive model of the risk of being COVID-19 for patients admitted to the emergency room for dyspnea
time frame: inclusion day
description: demographic variables, usual history and treatments, episode characteristics (symptomatology, evolution, treatment taken) and data from the initial clinical examination will be collected by doctor
measure: Describe the characteristics of patients admitted to reCOP units according to their virological status
time frame: 30 days
description: The COVID-19 virological condition will be taken with PCR tests on naso-pharyngeal samples or on sputum for patients taking
measure: Virological status
time frame: 30 days
description: Virological status will be collected by a phone call at the patient
measure: Mortality status
time frame: 30 days
description: Mortality status will be collected by a phone call at the patient
arm group label: RECOP unit patient
description: All patients admit in RECOP unit for dyspnea can be included in this study if patient is agree. Then, doctor collects demographic variables, the usual history and treatments, the characteristics of the episode (symptomatology, evolution, treatment taken) and the data from the initial clinical examination will be identified.
intervention type: Other
intervention name: RECOP unit patient
description: All patients admit in RECOP unit for dyspnea can be included in this study if patient is agree. Then, doctor collects demographic variables, the usual history and treatments, the characteristics of the episode (symptomatology, evolution, treatment taken) and the data from the initial clinical examination will be identified.
arm group label: RECOP unit patient
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
last name: Paul-Henri Auboiroux, MD
role: Principal Investigator
affiliation: University Hospital of Toulouse
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Dyspnea
mesh term: Emergencies
sharing ipd: No