NutriCovid30 : Nutritional Evaluation for Covid-19 Infection at D30

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

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

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Other: Interview

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 403

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • Marie-France VAILLANT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited after they are discharged from Hospital Covid Units

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prospective cohort University Hospital, Grenoble; Semi-structured survey administered on the phone, once, one month after discharge from hospital. The interview will not be recorded.	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
Prospective cohort University Hospital, Toulouse; Semi-structured survey administered on the phone, once, one month after discharge from hospital. The interview will not be recorded.	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
Prospective cohort University Hospital, Nancy; Semi-structured survey administered on the phone, once, one month after discharge from hospital. The interview will not be recorded.	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
Prospective cohort University Hospital, Rennes; Semi-structured survey administered on the phone, once, one month after discharge from hospital. The interview will not be recorded.	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
Prospective cohort Hospices Civils de Lyon; Semi-structured survey administered on the phone, once, one month after discharge from hospital. The interview will not be recorded.	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
Prospective cohort Assistance Publique Hôpitaux de Paris; Semi-structured survey administered on the phone, once, one month after discharge from hospital. The interview will not be recorded.	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
Prospective cohort University Hospital, Rouen; Semi-structured survey administered on the phone, once, one month after discharge from hospital. The interview will not be recorded.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Covid-19 repercussions	Quantifying unscheduled consultations or hospitalisations in the month following discharge from hospital	one month after hospital discharge

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: University Grenoble Alps
• Investigators: Principal Investigator: Marie-France VAILLANT, PhD, Centre Hospitalier Universitaire Grenoble Alpes

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2020
• Primary Completion (Actual): July 10, 2020
• Study Completion (Actual): July 10, 2020

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: April 24, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 24, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2020-A01120-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No