NCT04451694: NutriCoviDom

Nutritional Follow up After Hospital Discharge for Coronavirus Disease-19

Status unknown Last updated 30 June 2020

What this trial tests

trial testing nutritional intervention in Covid-19 in 800 participants. Status unknown.

Timeline

1 April 2020

Primary endpoint
30 July 2020

30 November 2020

Quick facts

Lead sponsor	Central Hospital, Nancy, France
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	800
Start date	1 April 2020
Primary completion	30 July 2020
Estimated completion	30 November 2020
Sites	1 location across France

Drugs / interventions tested

• nutritional intervention

Conditions studied

• Covid-19 — all drugs for Covid-19 →

Sponsor

Central Hospital, Nancy, France

Who can join

16 and older, any sex, with Covid-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Long-Term Evolution of Malnutrition and Loss of Muscle Strength after COVID-19: A Major and Neglected Component of Long COVID-19.
   Gérard M, Mahmutovic M, Malgras A, Michot N, et al · · 2021 · cited 45× · PMID 34836219 · DOI 10.3390/nu13113964
2. Impact of severe SARS-CoV-2 infection on nutritional status and subjective functional loss in a prospective cohort of COVID-19 survivors.
   Quilliot D, Gérard M, Bonsack O, Malgras A, et al · · 2021 · cited 19× · PMID 34261689 · DOI 10.1136/bmjopen-2021-048948
3. Assessment of dynapenia and undernutrition in primary care, a systematic screening study in community medicine.
   Treuil M, Mahmutovic M, Di Patrizio P, Nguyen-Thi PL, et al · · 2023 · cited 4× · PMID 37739706 · DOI 10.1016/j.clnesp.2023.08.003