NCT04503525

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

January 6, 2022

Status Verified

January 1, 2022

Enrollment Period

1 year

First QC Date

August 4, 2020

Last Update Submit

January 5, 2022

Conditions

Keywords

COVID-19Nutrition disorders

Outcome Measures

Primary Outcomes (1)

  • Nutritional status of COVID infected patients

    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

    Up to 72 hours

Secondary Outcomes (2)

  • Correlation between the nutritional status and the supplemental oxygen requirement

    Up to 72 hours

  • Correlation between the nutritional status and the prognostic after hospitalization

    Up to 72 hours

Study Arms (1)

COVID 19 hospitalized patients

COVID 19 infected patients admitted in conventional hospitalization for less than 72 hours

Other: Nutritional assessment

Interventions

Nutritional assessment in COVID patients

COVID 19 hospitalized patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with COVID 19 disease

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint-Vincent Hospital

Lille, Haut-de-France, 59000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The albuminemia in blood will be determined

MeSH Terms

Conditions

Severe Acute Respiratory SyndromeNutrition DisordersCOVID-19

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesNutritional and Metabolic DiseasesPneumonia, ViralPneumoniaLung Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Arnaud Cortet, MD

    GHICL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2020

First Posted

August 7, 2020

Study Start

May 25, 2020

Primary Completion

May 25, 2021

Study Completion

June 30, 2021

Last Updated

January 6, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations