<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/NCT04430322</url>
  </required_header>
  <id_info>
    <org_study_id>2020-02Obs-CHRMT</org_study_id>
    <nct_id>NCT04430322</nct_id>
  </id_info>
  <brief_title>Covid-19 at the Regional Medical Center Metz-Thionville: a Descriptive Study</brief_title>
  <acronym>COMETE-19</acronym>
  <official_title>Coronavirus Disease 2019 (Covid-19) at the Regional Hospital Center Metz-Thionville: a Descriptive Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Régional Metz-Thionville</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Régional Metz-Thionville</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>
      France and especially the region &quot;Grand Est&quot; have been damaged by the COVID-19 pandemic. This&#xD;
      pandemic resulted in a reorganization of the hospitalization sectors.&#xD;
&#xD;
      In order to better understand the disease, the investigators wish to carry out a descriptive&#xD;
      analysis of hospitalized patient data. This study would notably allow us to identify some&#xD;
      prognostic factors.&#xD;
&#xD;
      The main objective of this study is to identify individual factors that are associated with a&#xD;
      poor prognosis (with ICU admission or death).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Actual">June 1, 2022</completion_date>
  <primary_completion_date type="Actual">June 1, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>ICU admission</measure>
    <time_frame>Day 1</time_frame>
    <description>Number of ICU admission during the hospitalization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospitalization</measure>
    <time_frame>Day 1</time_frame>
    <description>The duration of the hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay at the ICU</measure>
    <time_frame>Day 1</time_frame>
    <description>The duration of stay at the ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>Day 1</time_frame>
    <description>The occurrence of death during the stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CT scan result</measure>
    <time_frame>Day 1</time_frame>
    <description>Evocative CT scan result</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C reactive protein</measure>
    <time_frame>Day 1</time_frame>
    <description>C reactive protein value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Count</measure>
    <time_frame>Day 1</time_frame>
    <description>Blood Count value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sodium</measure>
    <time_frame>Day 1</time_frame>
    <description>Sodium value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urea</measure>
    <time_frame>Day 1</time_frame>
    <description>Urea value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Troponine</measure>
    <time_frame>Day 1</time_frame>
    <description>Troponine value via biological data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liver function</measure>
    <time_frame>Day 1</time_frame>
    <description>Transaminases value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coagulation test</measure>
    <time_frame>Day 1</time_frame>
    <description>Quick test result</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creatinine</measure>
    <time_frame>day 1</time_frame>
    <description>creatinine value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clearance</measure>
    <time_frame>day 1</time_frame>
    <description>creatinine clearance value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potassium</measure>
    <time_frame>day 1</time_frame>
    <description>potassium value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calcium</measure>
    <time_frame>day 1</time_frame>
    <description>calcium value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gamma-glutamyl transpeptidase</measure>
    <time_frame>day 1</time_frame>
    <description>Gamma-glutamyl transpeptidase value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bilirubine</measure>
    <time_frame>day 1</time_frame>
    <description>Bilirubine value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcaline phosphatase</measure>
    <time_frame>Day 1</time_frame>
    <description>Alcaline phosphatase value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prothrombine</measure>
    <time_frame>Day 1</time_frame>
    <description>Prothrombine value</description>
  </secondary_outcome>
  <enrollment type="Actual">1045</enrollment>
  <condition>COVID</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patient hospitalized in COVID Unit at the Regional Hospital Center Metz-Thionville during&#xD;
        the COVID-19 pandemic with a PCR positive or COVID confirmed with clinical evidence and CT&#xD;
        scan.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient hospitalized in COVID Unit at the Regional Hospital Center Metz-Thionville&#xD;
             during the COVID 19 pandemic&#xD;
&#xD;
          -  PCR positive or COVID confirmed with clinical evidence and CT scan&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not willing to participate via using their medical files&#xD;
&#xD;
          -  Patient transferred after a brief stay in another hospital&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHR Metz Thionville</name>
      <address>
        <city>Metz</city>
        <zip>57085</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>August 28, 2023</last_update_submitted>
  <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04430322
org study id: 2020-02Obs-CHRMT
nct id: NCT04430322
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
France and especially the region "Grand Est" have been damaged by the COVID-19 pandemic. This
      pandemic resulted in a reorganization of the hospitalization sectors.

      In order to better understand the disease, the investigators wish to carry out a descriptive
      analysis of hospitalized patient data. This study would notably allow us to identify some
      prognostic factors.

      The main objective of this study is to identify individual factors that are associated with a
      poor prognosis (with ICU admission or death).
observational model: Other
time perspective: Retrospective
measure: ICU admission
time frame: Day 1
description: Number of ICU admission during the hospitalization
measure: Hospitalization
time frame: Day 1
description: The duration of the hospitalization
measure: Length of stay at the ICU
time frame: Day 1
description: The duration of stay at the ICU
measure: Death
time frame: Day 1
description: The occurrence of death during the stay
measure: CT scan result
time frame: Day 1
description: Evocative CT scan result
measure: C reactive protein
time frame: Day 1
description: C reactive protein value
measure: Blood Count
time frame: Day 1
description: Blood Count value
measure: Sodium
time frame: Day 1
description: Sodium value
measure: Urea
time frame: Day 1
description: Urea value
measure: Troponine
time frame: Day 1
description: Troponine value via biological data
measure: Liver function
time frame: Day 1
description: Transaminases value
measure: Coagulation test
time frame: Day 1
description: Quick test result
measure: Creatinine
time frame: day 1
description: creatinine value
measure: Clearance
time frame: day 1
description: creatinine clearance value
measure: Potassium
time frame: day 1
description: potassium value
measure: Calcium
time frame: day 1
description: calcium value
measure: Gamma-glutamyl transpeptidase
time frame: day 1
description: Gamma-glutamyl transpeptidase value
measure: Bilirubine
time frame: day 1
description: Bilirubine value
measure: Alcaline phosphatase
time frame: Day 1
description: Alcaline phosphatase value
measure: Prothrombine
time frame: Day 1
description: Prothrombine value
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor