SARS-CoV-2CodePRONUTNCT04672343
Prognostic Impact of the Nutritional Status of Individuals Aged 70 Years and Older With SARS-CoV-2
An observational study of SARS-CoV-2, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Mortality due to Covid-19 is much higher in the elderly. There are several reasons for the vulnerability of the elderly to the coronavirus: a less efficient immune system, underlying chronic conditions, less protected living conditions. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- Data collection and Querying the INSEE database
- How many people
- 426 participants
- Where
- 1 siteFrance
- Study dates
- 19 Oct 2020to 18 Oct 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Seniors with CoV-2-RASS
Who may be able to join
- SARS-CoV-2 test positive (positive PCR test or evocative CT scan) or negative (with clinical suspicion of COVID, negative PCR test and non-evocative CT scan)
- Age ≥ 70 years old
- Hospitalization at Dijon University Hospital
- Person or legal representative has not stated their opposition to inclusion in the study after being informed
Who cannot join
- Person subject to a measure of judicial safeguard
- Non-affiliated or non-beneficiary of national health insurance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IPrognostic Impact of the Nutritional Status of Individuals Aged 70 Years and Older With SARS-CoV-2
Mortality due to Covid-19 is much higher in the elderly. There are several reasons for the vulnerability of the elderly to the coronavirus: a less efficient immune system, underlying chronic conditions, less protected living conditions. They may also present a poor nutritional state and/or degraded metabolic reserves aggravating an underlying state of frailty. The prevalence of the risk of undernutrition in elderly patients with COVID-19 is high. The evolution of the nutritional status of people aged 70 years or older infected with SARS-Cov-2 is not yet well known. The prognosis of these patients could depend on their nutritional status at the time of the disease. In view of the lack of data, it would be interesting to compare the risk of mortality based on nutritional status in individuals with vs. those without COVID-19.
- Conditions
- SARS-CoV-2
- Being tested
- Data collection, Querying the INSEE database
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
from D0 to hospital discharge
Querying the INSEE databaseOther
Vital status at 3 months and 12 months
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Measured: to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start19 Oct 2020
- Primary completion18 Oct 2021
- Study completion18 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Retrospective
- Enrolment
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672343
- Sponsor's protocol ID
- PUTOT AOIc 2020
- Acronym
- CodePRONUT
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2020
- Last updated
- 2 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Putot A, Guyot C, Manckoundia P, Van Wymelbeke-Delannoy V. Association of body mass index with long-term outcomes in older adults hospitalized for COVID-19: an observational study. Sci Rep. 2024 Mar 29;14(1):7512. doi: 10.1038/s41598-024-58388-x.
PubMed 38553629
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IPrognostic Impact of the Nutritional Status of Individuals Aged 70 Years and Older With SARS-CoV-2
- ClinicalTrials.gov ID
- NCT04672343
- Acronym / sponsor ID
- CodePRONUT / PUTOT AOIc 2020
- Conditions
- SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 18 Oct 2021 (actual)
- Study completion
- 18 Oct 2021 (actual)
- First posted
- 17 Dec 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.
Mortality due to Covid-19 is much higher in the elderly. There are several reasons for the vulnerability of the elderly to the coronavirus: a less efficient immune system, underlying chronic conditions, less protected living conditions. They may also present a poor nutritional state and/or degraded metabolic reserves aggravating an underlying state of frailty. The prevalence of the risk of undernutrition in elderly patients with COVID-19 is high. The evolution of the nutritional status of people aged 70 years or older infected with SARS-Cov-2 is not yet well known. The prognosis of these patients could depend on their nutritional status at the time of the disease. In view of the lack of data, it would be interesting to compare the risk of mortality based on nutritional status in individuals with vs. those without COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Seniors with CoV-2-RASS
Key inclusion criteria (4 listed)
- SARS-CoV-2 test positive (positive PCR test or evocative CT scan) or negative (with clinical suspicion of COVID, negative PCR test and non-evocative CT scan)
- Age ≥ 70 years old
- Hospitalization at Dijon University Hospital
- Person or legal representative has not stated their opposition to inclusion in the study after being informed
Key exclusion criteria (2 listed)
- Person subject to a measure of judicial safeguard
- Non-affiliated or non-beneficiary of national health insurance
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 |
|---|---|---|
| Data collectionfrom D0 to hospital discharge | Other | – |
| Querying the INSEE databaseVital status at 3 months and 12 months | Other | – |
Primary outcome
Death
Time frame: to 3 months
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 2 Feb 2026.
- Results publication: PubMed 38553629Putot A, Guyot C, Manckoundia P, Van Wymelbeke-Delannoy V. Association of body mass index with long-term outcomes in older adults hospitalized for COVID-19: an observational study. Sci Rep. 2024 Mar 29;14(1):7512. doi: 10.1038/s41598-024-58388-x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-2, run by Centre Hospitalier Universitaire Dijon 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 4 inclusion and 2 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 2 Feb 2026. 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?
Death (time frame: to 3 months). 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 NCT04672343, which also lists 1 linked publication.
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 2 Feb 2026.