SARS-CoVDenutCOVIDNCT04503525
Nutritional Assessment of Hospitalized Patients With COVID-19
An observational study of SARS-CoV and Nutrition Disorders, run by Lille Catholic University at 1 site in France.
Trial summary
The nutritional consequences of the infection by the SARS-CoV-2 are as follows: A severe respiratory infection induces an inflammatory syndrome and hypercatabolism, as well as an increase in energy expenditure related to ventilatory work; nutritional requirements (calories and protein) are therefore increased. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV, Nutrition Disorders
- What is being tested?
- Nutritional assessment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 25 May 2020to 30 Jun 2021
- 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: Patient with COVID 19 disease
Who may be able to join
- Patient on conventional hospitalization (duration less than 72 hours)
- Age > 18 years old
- COVID 19 diagnosed by Real Time Polymerase Chain Reaction (RT-PCR)
- Patient agreed to participate in the study
- Patient affiliated to French social security
Who cannot join
- Patient hospitalized in intensive care units during more than 72 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Assessment of French Hospitalized Patients Infected With COVID-19
The nutritional consequences of the infection by the SARS-CoV-2 are as follows:
- A severe respiratory infection induces an inflammatory syndrome and hypercatabolism, as well as an increase in energy expenditure related to ventilatory work; nutritional requirements (calories and protein) are therefore increased.
- Food intake is often reduced by several factors: anorexia secondary to infection, respiratory discomfort, anosmia, ageusia, obesity, stress, confinement, organizational problems limiting meal assistance.
Then, it is important to asses the nutritional status of COVID patients hospitalized in conventional COVID units (excluding intensive care).
- Conditions
- SARS-CoV, Nutrition Disorders
- Being tested
- Nutritional assessment
- Keywords
- COVID-19, Nutrition disorders
- Medical subject headings
- Severe Acute Respiratory Syndrome, Nutrition Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional assessmentOther
Nutritional assessment in COVID patients
| Study group | Role | What they receive |
|---|---|---|
| COVID 19 hospitalized patients | COVID 19 infected patients admitted in conventional hospitalization for less than 72 hours Receives: Other: Nutritional assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional status of COVID infected patients
The nutritional status of patients within the first 72 hours after hospital admission will be categorized according to the French Haute Authorité de Santé (France, 2019)
- non-malnourished patient
- moderately malnourished patient
- severely malnourished patient
Measured: Up to 72 hours
Secondary outcomes (2)
Correlation between the nutritional status and the supplemental oxygen requirement
The supplemental oxygen requirement classified as follows:
- non-severe: no need of Oxygen
- light: 1 - 2 l/min
- moderate: 3 - 5 l/min
- severe: > 5 l/min
- critical: mechanical ventilation
Measured: Up to 72 hours
Correlation between the nutritional status and the prognostic after hospitalization
The prognostic after hospitalization will be classified as follows:
- Hospital discharge
- Transfer to the intensive care unit
- Transfer to other unit
- Follow-up care and rehabilitation
- Death
Measured: Up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start25 May 2020
- Primary completion25 May 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoVStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud Cortet, MD, Principal investigator, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503525
- Sponsor's protocol ID
- RC-P00100
- Acronym
- DenutCOVID
- Status last verified
- Jan 2022
- First submitted
- 4 Aug 2020
- Last updated
- 6 Jan 2022
- 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 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Assessment of French Hospitalized Patients Infected With COVID-19
- ClinicalTrials.gov ID
- NCT04503525
- Acronym / sponsor ID
- DenutCOVID / RC-P00100
- Conditions
- SARS-CoV, Nutrition Disorders
- Keywords
- COVID-19, Nutrition disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 25 May 2020 (actual)
- Primary completion
- 25 May 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 7 Aug 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.
The nutritional consequences of the infection by the SARS-CoV-2 are as follows:
- A severe respiratory infection induces an inflammatory syndrome and hypercatabolism, as well as an increase in energy expenditure related to ventilatory work; nutritional requirements (calories and protein) are therefore increased.
- Food intake is often reduced by several factors: anorexia secondary to infection, respiratory discomfort, anosmia, ageusia, obesity, stress, confinement, organizational problems limiting meal assistance.
Then, it is important to asses the nutritional status of COVID patients hospitalized in conventional COVID units (excluding intensive care).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID 19 hospitalized patients | – | Other: Nutritional assessmentCOVID 19 infected patients admitted in conventional hospitalization for less than 72 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with COVID 19 disease
Key inclusion criteria (5 listed)
- Patient on conventional hospitalization (duration less than 72 hours)
- Age > 18 years old
- COVID 19 diagnosed by Real Time Polymerase Chain Reaction (RT-PCR)
- Patient agreed to participate in the study
- Patient affiliated to French social security
Key exclusion criteria (1 listed)
- Patient hospitalized in intensive care units during more than 72 hours
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 assessmentNutritional assessment in COVID patients | Other | COVID 19 hospitalized patients |
Primary outcome
Nutritional status of COVID infected patients
Time frame: Up to 72 hours
The nutritional status of patients within the first 72 hours after hospital admission will be categorized according to the French Haute Authorité de Santé (France, 2019) * non-malnourished patient * moderately malnourished patient * severely malnourished patient
2 secondary outcomes
Correlation between the nutritional status and the supplemental oxygen requirement
Time frame: Up to 72 hours
Correlation between the nutritional status and the prognostic after hospitalization
Time frame: Up to 72 hours
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 6 Jan 2022.
- 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.
Arnaud Cortet, MD principal investigator
GHICL
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 SARS-CoV and Nutrition Disorders, run by Lille Catholic University 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 5 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: finished, as of the sponsor's last update on 6 Jan 2022. 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?
Nutritional status of COVID infected patients (time frame: Up to 72 hours). 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 6 Jan 2022.