NutriCovid30 : Nutritional Evaluation for Covid-19 Infection at D30

COVID-19 Clinical Trial

Official title:

Evaluation of the Repercussions of the Coronavirus (Covid 19) Infection on Nutritional Health Status and Nutritional Care : an Observational French Cohort Study One Month After Their Discharge From Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04365816
• Other study ID #: 2020-A01120-39
• Status: Completed
• Start date: April 30, 2020
• Est. completion date: July 10, 2020

Study information

• Verified date: July 2020
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Describe the main clinical features impacting the food intake, and therefore the nutritional status of a population infected by a coronavirus.

Description:

The recent Covid-19 outbreak has brought USA, European, British and French nutrition learned societies to publish recommendations for the nutritional management of patients infected with the SARS-CoV-2. They reminded that there is a risk of malnutrition for that population.

The emergency and rapid evolution in the situation have led to severe cases of anosmia, ageusia, diarrhea, odynophagia, anorexia etc.. Some of the first patients cured from Covid-19 have lost up to 10 kgs.

To this day, there is no available information regarding either nutritional characteristics or nutritional interventions (enteral or parenteral nutrition, oral nutritional supplements, dietary supplementations) for Covid-19 patients.

The objective of this study is to describe nutritional consequences of the Covid-19 infection for adults, 30 days after their discharge from hospital, as well as the nutritional care they received.

Type and proportion of chronic diseases will be assessed in this trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 403
• Est. completion date: July 10, 2020
• Est. primary completion date: July 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 30 days or more after discharge from hospital for Covid-19

• Patient received information about the trial and gave his/her consent

• Patient capable of answering the phone (alone or with some help)

Exclusion Criteria:

• Patient diseased

• impossibility to collect information from the patient or one of his/her relatives

• Patient protected by the French Public Health Code (art. L1121-5 à L1121-8)

Related Conditions & MeSH terms

• COVID-19
• Infection

Intervention

Other:
• Interview
A survey was created, aiming to collect information about prior history of chronic disease, the Self-Evaluation of Food Intake, dysregulations (anosmia, ageusia...), anthropometric data, food data during and after hospitalisation, healthcare consumption since the discharge from hospital

Locations

Country	Name	City	State
France	Marie-France VAILLANT	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	University Grenoble Alps

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of food intake at 1 month after discharge from hospital for COVID	Self assessment on the SEFI (Self-Evaluation of Food Intake) scale at one month after hospital discharge: 0 corresponds to the worsen score (no ingesta) and 10 corresponds to the best (same ingesta than before the disease)	one month after hospital discharge
Secondary	Weight variation during the infection	Self-reported weight in kilograms, or in the absence of self-reported variations before the disease, during hospitalisation, at hospital discharge, one month after hospital discharge	one month after hospital discharge
Secondary	Clinical signs limiting food intake	Effect of these factors (anorexia, dysgeusia, Ear Nose and Throat pain, swallowing disorders, intestinal transit disorders...) on SEFI and weight	one month after hospital discharge
Secondary	Factors limiting food intake	Effect of these factors (supply difficulties, disease-related food disgust, limiting food habits or prior diet, hydration difficulties, need for help) on SEFI and weight	one month after hospital discharge
Secondary	Implemented nutritional strategy	Effect of nutritional strategy and interventions that were implemented (nutritional advice, adapted meals, oral nutritional supplementation, enteral and parenteral nutrition during hospitalisation and one month after hospital discharge) on SEFI and weight	one month after hospital discharge
Secondary	Pre-existing chronic disorders	Effect of pre-existing chronic disorders (pulmonary, chronic inflammatory bowel disease, cardio-vascular disease, diabetes, obesity, cognitive disorders, immunodepression, cancer, inflammatory joint disorder) on SEFI and weight	one month after hospital discharge
Secondary	Covid-19 repercussions	Quantifying unscheduled consultations or hospitalisations in the month following discharge from hospital	one month after hospital discharge