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

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19

• Study Type: Observational
• Enrollment (Anticipated): 700

Contacts and Locations

• Study Contact: Name: Cédric ANNWEILER, MD, PhD; Phone Number: +33 02 41 35 47 25; Email: cedric.annweiler@chu-angers.fr

Study Locations

• France
  • Angers, France, 49933
    • Recruiting
    • Angers University Hospital
    • Contact: Cedric ANNWEILER, MD, PhD; Phone Number: (+33)241354725; Email: cedric.annweiler@chu-angers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All consecutive patients meeting the eligibility criteria over the study period.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical history and co-morbidities	listing of medical history and co-morbidities data provided by the physician and the family during hospitalization	baseline
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
Electrocardiography QT Interval	all electrocardiograms performed during hospitalization	baseline
Number of different therapeutic classes	Number of different therapeutic classes taken per day.	baseline
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
Biological parameters	Characterization of the COVID-19 impact on the biological parameters evaluated by blood test.	baseline
Medical imaging results	Assessment of lesion extension (percent) with medical imaging results (thoracic scan)	baseline
Diagnosis of COVID-19	Recovery of the diagnosis method (PCR or thoracic scan)	baseline
Length of hospitalization		at the 3-month follow-up
Number of death from any cause		at the 3-month follow-up
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
Length of hospitalization		at the 12-month follow-up
Number of death from any cause		at the 12-month follow-up
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

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: Cédric ANNWEILER, MD, PhD, University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): December 20, 2021
• Last Update Submitted That Met QC Criteria: December 3, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: elderly; coronavirus disease
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2020/100; ar20-0087v0 (Other Identifier: CNIL)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No