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

NCT04560608 | Unknown

• 2 other identifiers: 2020/100ar20-0087v0
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Covid19

Keywords

elderly; coronavirus disease

Outcome Measures

Primary Outcomes (14)

• 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

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Angers University Hospital

Angers, 49933, France

RECRUITING

Related Publications (1)

• Briere O, Otekpo M, Asfar M, Gautier J, Sacco G, Annweiler C; GERIA-COVID study group. Initial functional disability as a 1-year prognostic factor in geriatric patients hospitalized with SARS-CoV-2 infection. PLoS One. 2023 Jul 27;18(7):e0289297. doi: 10.1371/journal.pone.0289297. eCollection 2023.

  PMID: 37498909 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Cédric ANNWEILER, MD, PhD

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cédric ANNWEILER, MD, PhD

CONTACT

02 41 35 47 25; cedric.annweiler@chu-angers.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 23, 2020
• Study Start: March 15, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: December 20, 2021

Record last verified: 2021-12

Locations

FR (1)