Nutritional Follow up After Hospital Discharge for Coronavirus Disease-19 (NutriCoviDom)

Coronavirus infection is responsible for muscle wasting (sarcopenia), especially during prolonged stays in intensive care. Sarcopenia, in its functional aspect also seems major in patients hospitalized for this infection, in non-ICU unit. Weight loss also appears to be significant, despite a prevalence of overweight and obesity in severe forms. Undernutrition in the obese patient is also possible (undernourished obese and sarcopenia obesity). Anosmia and dysgeusia participate in undernutrition by reducing energy intake. The rehabilitation of these patients requires nutritional support (increased protein intake) associated with progressive retraining to physical activity.

An early and proactive management procedure within Coronavirus disease-19 units has been implemented in conjunction with the Transversal Nutrition Unit (TNU). This nutritional care must be continued after discharge. Follow-up by teleconsultation or telephone consultation is put in place after the patient's discharge Primary Objective: Evaluation of nutritional status at the time of admission and discharge and home follow-up in outgoing patients from Coronavirus disease-19 Units Secondary objectives: Description of the evolution of food intake, diversity of food and coverage of needs Evaluation of the muscular strength of the wrist (by grip test in hospital) and on the arms and legs after return home (visual analog scale) Evolution of anosmia and dysgeusia (at the time of hospital admission, at the time of hospital discharge and at home) Level of physical training before infection (IPAQ) Description of the general state of health measured by the performance index - world health organization scale Description of nutritional prescriptions Description of the prevention measures and incidence of Inappropriate Refeeding Syndrome (IRS) Care needs assessments

Study Overview

• Status: Unknown
• Conditions: Covid-19
• Intervention / Treatment: Other: nutritional intervention

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

Study Locations

• France
  • VANDOEUVRE LES Nancy, France, 54500
    • Recruiting
    • Quilliot
    • Contact: Didier Quilliot, Md PhD; Phone Number: 0684308721; Email: quilliot.d@orange.fr
    • Sub-Investigator: marine Gerard, resident

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

complete survey, about 800 patients. No sample List of patients discharged from COVID Units

Description

Inclusion Criteria:

• Covid positive (RT-PCR)

Exclusion Criteria:

• Unable to answer questions by telephone or teleconsultation directly or through a relative, minors under 16 years of age

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Covid-19 unit outgoing patients; nutritional evaluation and intervention	Other: nutritional intervention; nutritional evaluation and intervention and orientation towards adapted care establishment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
nutritional evaluation	weight	before Covid, at hospital discharge and between 7 and 45 days after discharge
nutritional evaluation	BMI	before Covid, at at the time of hospital admission, at the time of hospital discharge and between 7 and 45 days after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
muscle strenght	hand grip	at the time of hospital admission and at the time of hospital discharge
food intake	Caloric account	at the time of hospital admission, at the time of hospital discharge
food intake	self evaluation of food intake	between 7 and 45 days after discharge
muscle strenght	self evaluation of muscle strenght	between 7 and 45 days after discharge
biological nutritional status	albuminemia transthyretinemia electrolytes dosage inflammation status	at the time of hospital admission, at the time of hospital discharge
anosmia	anosmia and agueusia evolution	at the time of hospital admission, at the time of hospital discharge and between 7 and 45 days after discharge

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Publications and helpful links

General Publications

• Quilliot D, Gerard M, Bonsack O, Malgras A, Vaillant MF, Di Patrizio P, Jaussaud R, Ziegler O, Nguyen-Thi PL. Impact of severe SARS-CoV-2 infection on nutritional status and subjective functional loss in a prospective cohort of COVID-19 survivors. BMJ Open. 2021 Jul 14;11(7):e048948. doi: 10.1136/bmjopen-2021-048948.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Anticipated): July 30, 2020
• Study Completion (Anticipated): November 30, 2020

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 25, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: nutritional status; muscle strength; sarcopenia; malnutrition; diet intervention
• 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: 2020PI097

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