Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nutritional Assessment of Hospitalized Patients With COVID-19 (DenutCOVID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04503525
Recruitment Status : Recruiting
First Posted : August 7, 2020
Last Update Posted : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
Lille Catholic University

Brief Summary:

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).


Condition or disease Intervention/treatment
SARS-CoV Nutrition Disorders Other: Nutritional assessment

Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Nutritional Assessment of French Hospitalized Patients Infected With COVID-19
Actual Study Start Date : May 25, 2020
Estimated Primary Completion Date : May 25, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
COVID 19 hospitalized patients
COVID 19 infected patients admitted in conventional hospitalization for less than 72 hours
Other: Nutritional assessment
Nutritional assessment in COVID patients




Primary Outcome Measures :
  1. Nutritional status of COVID infected patients [ Time Frame: Up to 72 hours ]

    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


Secondary Outcome Measures :
  1. Correlation between the nutritional status and the supplemental oxygen requirement [ Time Frame: Up to 72 hours ]

    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

  2. Correlation between the nutritional status and the prognostic after hospitalization [ Time Frame: Up to 72 hours ]

    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


Biospecimen Retention:   Samples Without DNA
The albuminemia in blood will be determined


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with COVID 19 disease
Criteria

Inclusion Criteria:

  • Patient on conventional hospitalization (duration less than 72 hours)
  • Age > 18 years old
  • COVID 19 diagnosed by Real Time Polymerase Chain Reaction (RT-PCR)
  • Patient agreed to participate in the study
  • Patient affiliated to French social security

Exclusion Criteria:

  • Patient hospitalized in intensive care units during more than 72 hours

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04503525


Contacts
Layout table for location contacts
Contact: Amelie LANSIAUX, MD, PhD 0320225269 urm@ghicl.net
Contact: Amel Boulafa, Master 0320225269 boulafa.amel@ghicl.net

Locations
Layout table for location information
France
Saint-Vincent Hospital Recruiting
Lille, Haut-de-France, France, 59000
Contact: Arnaud CORTET, PhD    0320225269    cortet.arnaud@ghicl.net   
Contact: Amel Boulafa, Master    0320225269    boulafa.amel@ghicl.net   
Sponsors and Collaborators
Lille Catholic University
Investigators
Layout table for investigator information
Principal Investigator: Arnaud Cortet, MD GHICL
Layout table for additonal information
Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT04503525    
Other Study ID Numbers: RC-P00100
First Posted: August 7, 2020    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lille Catholic University:
COVID-19
Nutrition disorders
Additional relevant MeSH terms:
Layout table for MeSH terms
Nutrition Disorders