<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/NCT04503525</url>
  </required_header>
  <id_info>
    <org_study_id>RC-P00100</org_study_id>
    <nct_id>NCT04503525</nct_id>
  </id_info>
  <brief_title>Nutritional Assessment of Hospitalized Patients With COVID-19</brief_title>
  <acronym>DenutCOVID</acronym>
  <official_title>Nutritional Assessment of French Hospitalized Patients Infected With COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lille Catholic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lille Catholic University</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 nutritional consequences of the infection by the SARS-CoV-2 are as follows:&#xD;
&#xD;
        -  A severe respiratory infection induces an inflammatory syndrome and hypercatabolism, as&#xD;
           well as an increase in energy expenditure related to ventilatory work; nutritional&#xD;
           requirements (calories and protein) are therefore increased.&#xD;
&#xD;
        -  Food intake is often reduced by several factors: anorexia secondary to infection,&#xD;
           respiratory discomfort, anosmia, ageusia, obesity, stress, confinement, organizational&#xD;
           problems limiting meal assistance.&#xD;
&#xD;
      Then, it is important to asses the nutritional status of COVID patients hospitalized in&#xD;
      conventional COVID units (excluding intensive care).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 25, 2020</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">May 25, 2021</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Nutritional status of COVID infected patients</measure>
    <time_frame>Up to 72 hours</time_frame>
    <description>The nutritional status of patients within the first 72 hours after hospital admission will be categorized according to the French Haute Authorité de Santé (France, 2019)&#xD;
non-malnourished patient&#xD;
moderately malnourished patient&#xD;
severely malnourished patient</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between the nutritional status and the supplemental oxygen requirement</measure>
    <time_frame>Up to 72 hours</time_frame>
    <description>The supplemental oxygen requirement classified as follows:&#xD;
non-severe: no need of Oxygen&#xD;
light: 1 - 2 l/min&#xD;
moderate: 3 - 5 l/min&#xD;
severe: &gt; 5 l/min&#xD;
critical: mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the nutritional status and the prognostic after hospitalization</measure>
    <time_frame>Up to 72 hours</time_frame>
    <description>The prognostic after hospitalization will be classified as follows:&#xD;
Hospital discharge&#xD;
Transfer to the intensive care unit&#xD;
Transfer to other unit&#xD;
Follow-up care and rehabilitation&#xD;
Death</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">90</enrollment>
  <condition>SARS-CoV</condition>
  <condition>Nutrition Disorders</condition>
  <arm_group>
    <arm_group_label>COVID 19 hospitalized patients</arm_group_label>
    <description>COVID 19 infected patients admitted in conventional hospitalization for less than 72 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nutritional assessment</intervention_name>
    <description>Nutritional assessment in COVID patients</description>
    <arm_group_label>COVID 19 hospitalized patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The albuminemia in blood will be determined&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with COVID 19 disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient on conventional hospitalization (duration less than 72 hours)&#xD;
&#xD;
          -  Age &gt; 18 years old&#xD;
&#xD;
          -  COVID 19 diagnosed by Real Time Polymerase Chain Reaction (RT-PCR)&#xD;
&#xD;
          -  Patient agreed to participate in the study&#xD;
&#xD;
          -  Patient affiliated to French social security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient hospitalized in intensive care units during more than 72 hours&#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>Arnaud Cortet, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>GHICL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Saint-Vincent Hospital</name>
      <address>
        <city>Lille</city>
        <state>Haut-de-France</state>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>January 5, 2022</last_update_submitted>
  <last_update_submitted_qc>January 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Nutrition disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Nutrition Disorders</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/NCT04503525
org study id: RC-P00100
nct id: NCT04503525
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The nutritional consequences of the infection by the SARS-CoV-2 are as follows:

        -  A severe respiratory infection induces an inflammatory syndrome and hypercatabolism, as
           well as an increase in energy expenditure related to ventilatory work; nutritional
           requirements (calories and protein) are therefore increased.

        -  Food intake is often reduced by several factors: anorexia secondary to infection,
           respiratory discomfort, anosmia, ageusia, obesity, stress, confinement, organizational
           problems limiting meal assistance.

      Then, it is important to asses the nutritional status of COVID patients hospitalized in
      conventional COVID units (excluding intensive care).
observational model: Other
time perspective: Prospective
measure: Nutritional status of COVID infected patients
time frame: Up to 72 hours
description: The nutritional status of patients within the first 72 hours after hospital admission will be categorized according to the French Haute Authorité de Santé (France, 2019)
non-malnourished patient
moderately malnourished patient
severely malnourished patient
measure: Correlation between the nutritional status and the supplemental oxygen requirement
time frame: Up to 72 hours
description: The supplemental oxygen requirement classified as follows:
non-severe: no need of Oxygen
light: 1 - 2 l/min
moderate: 3 - 5 l/min
severe: > 5 l/min
critical: mechanical ventilation
measure: Correlation between the nutritional status and the prognostic after hospitalization
time frame: Up to 72 hours
description: The prognostic after hospitalization will be classified as follows:
Hospital discharge
Transfer to the intensive care unit
Transfer to other unit
Follow-up care and rehabilitation
Death
arm group label: COVID 19 hospitalized patients
description: COVID 19 infected patients admitted in conventional hospitalization for less than 72 hours
intervention type: Other
intervention name: Nutritional assessment
description: Nutritional assessment in COVID patients
arm group label: COVID 19 hospitalized patients
The albuminemia in blood will be determined
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Arnaud Cortet, MD
role: Principal Investigator
affiliation: GHICL
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Nutrition Disorders
sharing ipd: No