Covid-19NutriCoviDomNCT04451694
Nutritional Follow up After Hospital Discharge for Coronavirus Disease-19
An observational study of Covid-19, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Covid-19
- What is being tested?
- nutritional intervention
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2020to 30 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: complete survey, about 800 patients. No sample List of patients discharged from COVID Units
Who may be able to join
- Covid positive (RT-PCR)
Who cannot join
- Unable to answer questions by telephone or teleconsultation directly or through a relative, minors under 16 years of age
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Quilliot
Vandœuvre-lès-Nancy, 54500
Didier Quilliot, Md PhD, 0684308721, quilliot.d@orange.fr
marine Gerard, resident
About this study
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
- Conditions
- Covid-19
- Being tested
- nutritional intervention
- Keywords
- nutritional status, malnutrition, diet intervention, sarcopenia, muscle strength
- Medical subject headings
- COVID-19, Malnutrition, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional interventionOther
nutritional evaluation and intervention and orientation towards adapted care establishment
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 unit outgoing patients | nutritional evaluation and intervention Receives: Other: nutritional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
nutritional evaluation
weight
Measured: before Covid, at hospital discharge and between 7 and 45 days after discharge
nutritional evaluation
BMI
Measured: 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
hand grip
Measured: at the time of hospital admission and at the time of hospital discharge
food intake
Caloric account
Measured: at the time of hospital admission, at the time of hospital discharge
food intake
self evaluation of food intake
Measured: between 7 and 45 days after discharge
muscle strenght
self evaluation of muscle strenght
Measured: between 7 and 45 days after discharge
biological nutritional status
albuminemia transthyretinemia electrolytes dosage inflammation status
Measured: at the time of hospital admission, at the time of hospital discharge
anosmia
anosmia and agueusia evolution
Measured: at the time of hospital admission, at the time of hospital discharge and between 7 and 45 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start1 Apr 2020
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid-19Studies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451694
- Sponsor's protocol ID
- 2020PI097
- Acronym
- NutriCoviDom
- Status last verified
- Jun 2020
- First submitted
- 15 Jun 2020
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37739706Quilliot 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.
PubMed 34261689
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Follow up After Hospital Discharge for Coronavirus Disease-19
- ClinicalTrials.gov ID
- NCT04451694
- Acronym / sponsor ID
- NutriCoviDom / 2020PI097
- Conditions
- Covid-19
- Keywords
- nutritional status, malnutrition, diet intervention, sarcopenia, muscle strength
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Covid-19 unit outgoing patients | – | Other: nutritional interventionnutritional evaluation and intervention |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- complete survey, about 800 patients. No sample List of patients discharged from COVID Units
Key inclusion criteria (1 listed)
- Covid positive (RT-PCR)
Key exclusion criteria (1 listed)
- Unable to answer questions by telephone or teleconsultation directly or through a relative, minors under 16 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutritional interventionnutritional evaluation and intervention and orientation towards adapted care establishment | Other | Covid-19 unit outgoing patients |
Primary outcome
nutritional evaluation
Time frame: before Covid, at hospital discharge and between 7 and 45 days after discharge
weight
nutritional evaluation
Time frame: before Covid, at at the time of hospital admission, at the time of hospital discharge and between 7 and 45 days after discharge
BMI
6 secondary outcomes
muscle strenght
Time frame: at the time of hospital admission and at the time of hospital discharge
food intake
Time frame: at the time of hospital admission, at the time of hospital discharge
food intake
Time frame: between 7 and 45 days after discharge
muscle strenght
Time frame: between 7 and 45 days after discharge
biological nutritional status
Time frame: at the time of hospital admission, at the time of hospital discharge
anosmia
Time frame: at the time of hospital admission, at the time of hospital discharge and between 7 and 45 days after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Derived from this study: PubMed 37739706Treuil 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.
- Derived from this study: PubMed 34261689Quilliot 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nutritional evaluation (time frame: before Covid, at hospital discharge and between 7 and 45 days after discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04451694, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.