NCT04451694

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

June 30, 2020

Status Verified

June 1, 2020

Enrollment Period

4 months

First QC Date

June 15, 2020

Last Update Submit

June 25, 2020

Conditions

Keywords

nutritional statusmalnutritiondiet interventionsarcopeniamuscle strength

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • muscle strenght

    at the time of hospital admission and at the time of hospital discharge

  • food intake

    at the time of hospital admission, at the time of hospital discharge

  • food intake

    between 7 and 45 days after discharge

  • muscle strenght

    between 7 and 45 days after discharge

  • biological nutritional status

    at the time of hospital admission, at the time of hospital discharge

  • +1 more secondary outcomes

Study Arms (1)

Covid-19 unit outgoing patients

nutritional evaluation and intervention

Other: nutritional intervention

Interventions

nutritional evaluation and intervention and orientation towards adapted care establishment

Covid-19 unit outgoing patients

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Covid positive (RT-PCR)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quilliot

Vandœuvre-lès-Nancy, 54500, France

RECRUITING

Related Publications (2)

  • Treuil M, Mahmutovic M, Di Patrizio P, Nguyen-Thi PL, Quilliot D. Assessment of dynapenia and undernutrition in primary care, a systematic screening study in community medicine. Clin Nutr ESPEN. 2023 Oct;57:561-568. doi: 10.1016/j.clnesp.2023.08.003. Epub 2023 Aug 5.

  • 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.

MeSH Terms

Conditions

COVID-19MalnutritionSarcopenia

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesNutrition DisordersNutritional and Metabolic DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2020

First Posted

June 30, 2020

Study Start

April 1, 2020

Primary Completion

July 30, 2020

Study Completion

November 30, 2020

Last Updated

June 30, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations