COVID-19NCT04365816
NutriCovid30 : Nutritional Evaluation for Covid-19 Infection at D30
An observational study of COVID-19, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Describe the main clinical features impacting the food intake, and therefore the nutritional status of a population infected by a coronavirus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Interview
- How many people
- 403 participants
- Where
- 1 siteFrance
- Study dates
- 30 Apr 2020to 10 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited after they are discharged from Hospital Covid Units
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Interview
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Interview | |
| 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. Receives: Other: Interview | |
| 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. Receives: Other: Interview | |
| 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. Receives: Other: Interview | |
| 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. Receives: Other: Interview | |
| 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. Receives: Other: Interview | |
| 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. Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: one month after hospital discharge
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: one month after hospital discharge
Covid-19 repercussions
Quantifying unscheduled consultations or hospitalisations in the month following discharge from hospital
Measured: one month after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start30 Apr 2020
- Primary completion10 Jul 2020
- Study completion10 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- University Grenoble Alps
- Responsible party
- Sponsor
- Investigators
- Marie-France VAILLANT, PhD, Principal investigator, Centre Hospitalier Universitaire Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365816
- Sponsor's protocol ID
- 2020-A01120-39
- Status last verified
- Jul 2020
- First submitted
- 24 Apr 2020
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04365816
- Acronym / sponsor ID
- 2020-A01120-39
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- University Grenoble Alps
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 10 Jul 2020 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 28 Apr 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.
Describe the main clinical features impacting the food intake, and therefore the nutritional status of a population infected by a coronavirus.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort University Hospital, Grenoble | – | Other: InterviewSemi-structured survey administered on the phone, once, one month after discharge from hospital. The interview will not be recorded. |
| Prospective cohort University Hospital, Toulouse | – | Other: InterviewSemi-structured survey administered on the phone, once, one month after discharge from hospital. The interview will not be recorded. |
| Prospective cohort University Hospital, Nancy | – | Other: InterviewSemi-structured survey administered on the phone, once, one month after discharge from hospital. The interview will not be recorded. |
| Prospective cohort University Hospital, Rennes | – | Other: InterviewSemi-structured survey administered on the phone, once, one month after discharge from hospital. The interview will not be recorded. |
| Prospective cohort Hospices Civils de Lyon | – | Other: InterviewSemi-structured survey administered on the phone, once, one month after discharge from hospital. The interview will not be recorded. |
| Prospective cohort Assistance Publique Hôpitaux de Paris | – | Other: InterviewSemi-structured survey administered on the phone, once, one month after discharge from hospital. The interview will not be recorded. |
| Prospective cohort University Hospital, Rouen | – | Other: InterviewSemi-structured survey administered on the phone, once, one month after discharge from hospital. The interview will not be recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited after they are discharged from Hospital Covid Units
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
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 |
|---|---|---|
| InterviewA 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 | Other | Prospective cohort Assistance Publique Hôpitaux de Paris, Prospective cohort Hospices Civils de Lyon, Prospective cohort University Hospital, Grenoble, Prospective cohort University Hospital, Nancy, Prospective cohort University Hospital, Rennes, Prospective cohort University Hospital, Rouen, Prospective cohort University Hospital, Toulouse |
Primary outcome
Evaluation of food intake at 1 month after discharge from hospital for COVID
Time frame: one month after hospital discharge
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)
6 secondary outcomes
Weight variation during the infection
Time frame: one month after hospital discharge
Clinical signs limiting food intake
Time frame: one month after hospital discharge
Factors limiting food intake
Time frame: one month after hospital discharge
Implemented nutritional strategy
Time frame: one month after hospital discharge
Pre-existing chronic disorders
Time frame: one month after hospital discharge
Covid-19 repercussions
Time frame: one month after hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Active, not recruiting
Working Towards Empowered Community-driven Approaches to Increase Vaccination and Preventive Care Engagement
COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Active, not recruitingObservational study
SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI
Spinal Cord Injuries, Traumatic Spinal Cord Injury
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.
Marie-France VAILLANT, PhD principal investigator
Centre Hospitalier Universitaire Grenoble Alpes
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 University Hospital, Grenoble 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 28 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of food intake at 1 month after discharge from hospital for COVID (time frame: one month after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2020.