<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/NCT04451694</url>
  </required_header>
  <id_info>
    <org_study_id>2020PI097</org_study_id>
    <nct_id>NCT04451694</nct_id>
  </id_info>
  <brief_title>Nutritional Follow up After Hospital Discharge for Coronavirus Disease-19</brief_title>
  <acronym>NutriCoviDom</acronym>
  <official_title>Nutritional Follow up After Hospital Discharge for Coronavirus Disease-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</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>
      Coronavirus infection is responsible for muscle wasting (sarcopenia), especially during&#xD;
      prolonged stays in intensive care. Sarcopenia, in its functional aspect also seems major in&#xD;
      patients hospitalized for this infection, in non-ICU unit. Weight loss also appears to be&#xD;
      significant, despite a prevalence of overweight and obesity in severe forms. Undernutrition&#xD;
      in the obese patient is also possible (undernourished obese and sarcopenia obesity). Anosmia&#xD;
      and dysgeusia participate in undernutrition by reducing energy intake. The rehabilitation of&#xD;
      these patients requires nutritional support (increased protein intake) associated with&#xD;
      progressive retraining to physical activity.&#xD;
&#xD;
      An early and proactive management procedure within Coronavirus disease-19 units has been&#xD;
      implemented in conjunction with the Transversal Nutrition Unit (TNU). This nutritional care&#xD;
      must be continued after discharge. Follow-up by teleconsultation or telephone consultation is&#xD;
      put in place after the patient's discharge Primary Objective: Evaluation of nutritional&#xD;
      status at the time of admission and discharge and home follow-up in outgoing patients from&#xD;
      Coronavirus disease-19 Units Secondary objectives: Description of the evolution of food&#xD;
      intake, diversity of food and coverage of needs Evaluation of the muscular strength of the&#xD;
      wrist (by grip test in hospital) and on the arms and legs after return home (visual analog&#xD;
      scale) Evolution of anosmia and dysgeusia (at the time of hospital admission, at the time of&#xD;
      hospital discharge and at home) Level of physical training before infection (IPAQ)&#xD;
      Description of the general state of health measured by the performance index - world health&#xD;
      organization scale Description of nutritional prescriptions Description of the prevention&#xD;
      measures and incidence of Inappropriate Refeeding Syndrome (IRS) Care needs assessments&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2020</start_date>
  <completion_date type="Anticipated">November 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 30, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>nutritional evaluation</measure>
    <time_frame>before Covid, at hospital discharge and between 7 and 45 days after discharge</time_frame>
    <description>weight</description>
  </primary_outcome>
  <primary_outcome>
    <measure>nutritional evaluation</measure>
    <time_frame>before Covid, at at the time of hospital admission, at the time of hospital discharge and between 7 and 45 days after discharge</time_frame>
    <description>BMI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>muscle strenght</measure>
    <time_frame>at the time of hospital admission and at the time of hospital discharge</time_frame>
    <description>hand grip</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>food intake</measure>
    <time_frame>at the time of hospital admission, at the time of hospital discharge</time_frame>
    <description>Caloric account</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>food intake</measure>
    <time_frame>between 7 and 45 days after discharge</time_frame>
    <description>self evaluation of food intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>muscle strenght</measure>
    <time_frame>between 7 and 45 days after discharge</time_frame>
    <description>self evaluation of muscle strenght</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>biological nutritional status</measure>
    <time_frame>at the time of hospital admission, at the time of hospital discharge</time_frame>
    <description>albuminemia transthyretinemia electrolytes dosage inflammation status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>anosmia</measure>
    <time_frame>at the time of hospital admission, at the time of hospital discharge and between 7 and 45 days after discharge</time_frame>
    <description>anosmia and agueusia evolution</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">800</enrollment>
  <condition>Covid-19</condition>
  <arm_group>
    <arm_group_label>Covid-19 unit outgoing patients</arm_group_label>
    <description>nutritional evaluation and intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>nutritional intervention</intervention_name>
    <description>nutritional evaluation and intervention and orientation towards adapted care establishment</description>
    <arm_group_label>Covid-19 unit outgoing patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        complete survey, about 800 patients. No sample List of patients discharged from COVID Units&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Covid positive (RT-PCR)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to answer questions by telephone or teleconsultation directly or through a&#xD;
             relative, minors under 16 years of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Quilliot</name>
      <address>
        <city>VANDOEUVRE LES Nancy</city>
        <zip>54500</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Didier Quilliot, Md PhD</last_name>
      <phone>0684308721</phone>
      <email>quilliot.d@orange.fr</email>
    </contact>
    <investigator>
      <last_name>marine Gerard, resident</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>June 25, 2020</last_update_submitted>
  <last_update_submitted_qc>June 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>nutritional status</keyword>
  <keyword>malnutrition</keyword>
  <keyword>diet intervention</keyword>
  <keyword>sarcopenia</keyword>
  <keyword>muscle strength</keyword>
  <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/NCT04451694
org study id: 2020PI097
nct id: NCT04451694
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Coronavirus infection is responsible for muscle wasting (sarcopenia), especially during
      prolonged stays in intensive care. Sarcopenia, in its functional aspect also seems major in
      patients hospitalized for this infection, in non-ICU unit. Weight loss also appears to be
      significant, despite a prevalence of overweight and obesity in severe forms. Undernutrition
      in the obese patient is also possible (undernourished obese and sarcopenia obesity). Anosmia
      and dysgeusia participate in undernutrition by reducing energy intake. The rehabilitation of
      these patients requires nutritional support (increased protein intake) associated with
      progressive retraining to physical activity.

      An early and proactive management procedure within Coronavirus disease-19 units has been
      implemented in conjunction with the Transversal Nutrition Unit (TNU). This nutritional care
      must be continued after discharge. Follow-up by teleconsultation or telephone consultation is
      put in place after the patient's discharge Primary Objective: Evaluation of nutritional
      status at the time of admission and discharge and home follow-up in outgoing patients from
      Coronavirus disease-19 Units Secondary objectives: Description of the evolution of food
      intake, diversity of food and coverage of needs Evaluation of the muscular strength of the
      wrist (by grip test in hospital) and on the arms and legs after return home (visual analog
      scale) Evolution of anosmia and dysgeusia (at the time of hospital admission, at the time of
      hospital discharge and at home) Level of physical training before infection (IPAQ)
      Description of the general state of health measured by the performance index - world health
      organization scale Description of nutritional prescriptions Description of the prevention
      measures and incidence of Inappropriate Refeeding Syndrome (IRS) Care needs assessments
observational model: Cohort
time perspective: Prospective
measure: nutritional evaluation
time frame: before Covid, at hospital discharge and between 7 and 45 days after discharge
description: weight
measure: nutritional evaluation
time frame: before Covid, at at the time of hospital admission, at the time of hospital discharge and between 7 and 45 days after discharge
description: BMI
measure: muscle strenght
time frame: at the time of hospital admission and at the time of hospital discharge
description: hand grip
measure: food intake
time frame: at the time of hospital admission, at the time of hospital discharge
description: Caloric account
measure: food intake
time frame: between 7 and 45 days after discharge
description: self evaluation of food intake
measure: muscle strenght
time frame: between 7 and 45 days after discharge
description: self evaluation of muscle strenght
measure: biological nutritional status
time frame: at the time of hospital admission, at the time of hospital discharge
description: albuminemia transthyretinemia electrolytes dosage inflammation status
measure: anosmia
time frame: at the time of hospital admission, at the time of hospital discharge and between 7 and 45 days after discharge
description: anosmia and agueusia evolution
arm group label: Covid-19 unit outgoing patients
description: nutritional evaluation and intervention
intervention type: Other
intervention name: nutritional intervention
description: nutritional evaluation and intervention and orientation towards adapted care establishment
arm group label: Covid-19 unit outgoing patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No