<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/NCT04497272</url>
  </required_header>
  <id_info>
    <org_study_id>20-PP-18</org_study_id>
    <nct_id>NCT04497272</nct_id>
  </id_info>
  <brief_title>Assesment of the Metabolomic Signature in COVID-19 Patients</brief_title>
  <acronym>SignCov</acronym>
  <official_title>Assesment of the Metabolomic Signature in COVID-19 Patients (SignCov Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nice</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nice</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>
      Metabolomics is the analysis of small molecules in a biological sample (cells, tissues or&#xD;
      biological fluids). It can potentially detect very sensitively any change related to a&#xD;
      pathology or exposure to a toxic agent. The analyses are fast, inexpensive and therefore&#xD;
      applicable in routine, particularly in health care. Given the emergence of this new disease,&#xD;
      COVID-19, there is a real need to better understand the pathophysiological mechanisms of&#xD;
      SARS-CoV-2 infection. In this context, metabolomics could have a place and could lead to the&#xD;
      development of interesting diagnostic or prognostic tools. The objective of this study is to&#xD;
      identify, through the analysis of biological samples (blood and urine), whether there is a&#xD;
      metabolomic signature in patients with COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 7, 2020</start_date>
  <completion_date type="Actual">July 31, 2022</completion_date>
  <primary_completion_date type="Actual">March 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Patient with COVID-19 disease</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Identifying the metabolomic signature</measure>
    <time_frame>Enrollment</time_frame>
    <description>To dentified a metabolomic profile using liquid chromatography combined with mass spectrometry (LC-MS) on the serum and urine of COVID-19 patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identification of the metabolomic profile according to clinical severity.</measure>
    <time_frame>Enrollment</time_frame>
    <description>Identification of the metabolomic profile of patients infected with SARS CoV 2 in the following subgroups: pauci-symptomatic patients, symptomatic patients without clinical severity criteria, and critically ill COVID-19 patients.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>COVID 19</condition>
  <arm_group>
    <arm_group_label>The metabolomic signature of COVID-19 patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>It will consist in the collection of 1 additional tubes at their blood draw and 1 urine sample.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>COVID-19 patients</intervention_name>
    <description>It will consist in the collection of 1 additional tubes at their blood draw and 1 urine sample.</description>
    <arm_group_label>The metabolomic signature of COVID-19 patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient over 18 years of age&#xD;
&#xD;
          -  affiliated to a social security scheme&#xD;
&#xD;
          -  consultant in the emergency department and/or being hospitalized for suspected SARS&#xD;
             CoV infection&#xD;
&#xD;
          -  confirmation, after medical examination, of the need for a biological examination&#xD;
             (this will negate the need for additional venipuncture)&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Patient who do not meet inclusion criteria&#xD;
&#xD;
          -  Person subject to a guardianship order&#xD;
&#xD;
          -  Opposition to the use of the data or samples (withdrawal of non-opposition) /&#xD;
             Sponsor's or investigator's decision&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>OCCELLI Céline</last_name>
    <role>Principal Investigator</role>
    <affiliation>Néphrologie, CHU de Nice</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de nice</name>
      <address>
        <city>Nice</city>
        <state>Alpes-Maritimes</state>
        <zip>06001</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>August 30, 2022</last_update_submitted>
  <last_update_submitted_qc>August 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2022</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>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/NCT04497272
org study id: 20-PP-18
nct id: NCT04497272
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Metabolomics is the analysis of small molecules in a biological sample (cells, tissues or
      biological fluids). It can potentially detect very sensitively any change related to a
      pathology or exposure to a toxic agent. The analyses are fast, inexpensive and therefore
      applicable in routine, particularly in health care. Given the emergence of this new disease,
      COVID-19, there is a real need to better understand the pathophysiological mechanisms of
      SARS-CoV-2 infection. In this context, metabolomics could have a place and could lead to the
      development of interesting diagnostic or prognostic tools. The objective of this study is to
      identify, through the analysis of biological samples (blood and urine), whether there is a
      metabolomic signature in patients with COVID-19.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Patient with COVID-19 disease
primary purpose: Diagnostic
masking: None (Open Label)
measure: Identifying the metabolomic signature
time frame: Enrollment
description: To dentified a metabolomic profile using liquid chromatography combined with mass spectrometry (LC-MS) on the serum and urine of COVID-19 patients
measure: Identification of the metabolomic profile according to clinical severity.
time frame: Enrollment
description: Identification of the metabolomic profile of patients infected with SARS CoV 2 in the following subgroups: pauci-symptomatic patients, symptomatic patients without clinical severity criteria, and critically ill COVID-19 patients.
arm group label: The metabolomic signature of COVID-19 patients
arm group type: Other
description: It will consist in the collection of 1 additional tubes at their blood draw and 1 urine sample.
intervention type: Other
intervention name: COVID-19 patients
description: It will consist in the collection of 1 additional tubes at their blood draw and 1 urine sample.
arm group label: The metabolomic signature of COVID-19 patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: OCCELLI Céline
role: Principal Investigator
affiliation: Néphrologie, CHU de Nice
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No