Elucidating the Symptomatic, Explanatory and Prognostic Characteristics of GERIAtric Patients Hospitalized for COVID-19

Covid19 Clinical Trial

— GERIA-COVID  

Official title:

Elucidating the Symptomatic, Explanatory and Prognostic Characteristics of GERIAtric Patients Hospitalized for COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04560608
• Other study ID #: 2020/100
• Secondary ID: ar20-0087v0
• Status: Recruiting
• Start date: March 15, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2021
• Source: University Hospital, Angers
• Contact: Cédric ANNWEILER, MD, PhD
• Phone: 02 41 35 47 25
• Email: cedric.annweiler[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Statement : - The emerging Coronavirus 2019 (COVID-19) disease, linked to the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) pathogen, has been spreading worldwide since December 2019, affecting millions of people and causing hundreds of thousands of deaths, particularly among the elderly. - The first epidemiological evidence available reveals a different expression of the disease in the elderly, associated with a high risk of delayed diagnosis and implementation of protective measures and a particularly high morbidity and mortality, especially among the frailest. - To date, there is no effective model for predicting the severity of COVID-19 in an individual. The investigators hypothesize that there are specificities of COVID-19 in the elderly, both etiological, diagnostic and prognostic, all of which are not yet known and understood.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Hospitalization in the Geriatric unit of the University Hospital (UH) of Angers from 15/03/2020 and until the closure of the COVID-19 geriatric sector

Exclusion Criteria:

• Opposition to the use of the information collected for research purposes.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Locations

Country	Name	City	State
France	Angers University Hospital	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medical history and co-morbidities	listing of medical history and co-morbidities data provided by the physician and the family during hospitalization	baseline
Primary	The physical examination data, and reports of relevant investigations data provided by the physician and the family during hospitalization	The demographic characteristics are age, sex, marital status, place of life, career, presence of un/formal assistance, …	baseline
Primary	Electrocardiography QT Interval	all electrocardiograms performed during hospitalization	baseline
Primary	Number of different therapeutic classes	Number of different therapeutic classes taken per day.	baseline
Primary	Comprehensive Geriatric Assessment (CGA)	Comprehensive geriatric assessment (CGA) is defined as a multidisciplinary diagnostic and treatment process that identifies medical, psychosocial, and functional capabilities of an older adult in order to develop a coordinated plan to maximize overall health with aging. CGA is based on the premise that a systematic evaluation of frail older persons by a team of health professionals may identify a variety of treatable health problems and lead to better health outcomes.	baseline
Primary	Biological parameters	Characterization of the COVID-19 impact on the biological parameters evaluated by blood test.	baseline
Primary	Medical imaging results	Assessment of lesion extension (percent) with medical imaging results (thoracic scan)	baseline
Primary	Diagnosis of COVID-19	Recovery of the diagnosis method (PCR or thoracic scan)	baseline
Primary	Length of hospitalization		at the 3-month follow-up
Primary	Number of death from any cause		at the 3-month follow-up
Primary	Reports of relevant investigations data provided by the physician and the family during the two-month telephone follow-up	The demographic characteristics are age, sex, marital status, place of life, career, presence of un/formal assistance, …	at the 3-month follow-up
Primary	Length of hospitalization		at the 12-month follow-up
Primary	Number of death from any cause		at the 12-month follow-up
Primary	Reports of relevant investigations data provided by the physician and the family during the two-month telephone follow-up	The demographic characteristics are age, sex, marital status, place of life, career, presence of un/formal assistance, …	at the 12-month follow-up