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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04503525
Other study ID # RC-P00100
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 25, 2020
Est. completion date June 30, 2021

Study information

Verified date January 2022
Source Lille Catholic University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date June 30, 2021
Est. primary completion date May 25, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Nutritional assessment
Nutritional assessment in COVID patients

Locations

Country Name City State
France Saint-Vincent Hospital Lille Haut-de-France

Sponsors (1)

Lead Sponsor Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Correlation between the nutritional status and the supplemental oxygen requirement 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
Up to 72 hours
Secondary Correlation between the nutritional status and the prognostic after hospitalization 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
Up to 72 hours
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