Prognostic Impact of the Nutritional Status of Individuals Aged 70 Years and Older With SARS-CoV-2

SARS-CoV-2 Clinical Trial

— CodePRONUT  

Official title:

IPrognostic Impact of the Nutritional Status of Individuals Aged 70 Years and Older With SARS-CoV-2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04672343
• Other study ID #: PUTOT AOIc 2020
• Status: Recruiting
• Start date: October 19, 2020
• Est. completion date: January 2022

Study information

• Verified date: December 2020
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Alain PUTOT
• Email: alain.putot[@]chu-dijon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2022
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Person subject to a measure of judicial safeguard

• Non-affiliated or non-beneficiary of national health insurance

Related Conditions & MeSH terms

• SARS-CoV-2

Intervention

Other:
• Data collection
from D0 to hospital discharge
• Querying the INSEE database
Vital status at 3 months and 12 months

Locations

Country	Name	City	State
France	Chu Dijon Bourogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death		to 3 months