Geriatric Population COVID-19 Observational Study (GEROCOVIDobs)

Raffaele Antonelli Incalzi

Status: Unknown

Conditions: COVID-19

Study type: Observational

Funder types: Other

Identifiers

NCT04379440

GC01-Obs

Details and patient eligibility

About

The GeroCovid e-Registry is a European de-identified clinical data electronic registry of geriatric patients at risk or suffering from COVID-19 (suspected and confirmed cases) observed since 1st March 2020 in the participating investigational sites.

Full description

Older adults (≥ 65 years) and pre-geriatric population (≥60 years and <65 years) are the ones most at risk from complications of COVID-19, including increased mortality, possibly in relationship with their comorbidity and frailty status.

The GeroCovid e-registry is intended to track Covid-19 pandemic impact on the general geriatric population and on age/care-setting related sub-populations.

The analysis of results is expected to facilitate the adoption of optimal standard of geriatric care during the pandemic.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Applying only to the " Acute Ward Patients " cohort:

   1. Hospitalised patients
   2. Suspected or known SARS-CoV-2 infection

2. Applying only to the "Nursing Homes (RSA)" cohort:

   1. Nursing Home Resident Older Adults
   2. Suspected or known SARS-CoV-2 infection

3. Applying only to the" Home and outpatients' care " cohort:

   a. Outpatients at risk of SARS-CoV-2 infection

4. Applying only to the" Dementia outpatients " cohort:

   1. Outpatients suffering from dementia according to NIA-AA criteria
   2. At risk of SARS-CoV-2 infection
   3. Ongoing treatment with anti-cholinesterase- dugs and/or anti-psychotics

5. Applying only to the" At home " cohort:

   a. Outpatients at risk of SARS-CoV-2 infection

6. Applying only to the " Outcomes " cohort:

   1. Age≥65 years
   2. Hospitalised patients diagnosed with SARS-CoV-2 infection

Exclusion criteria

1. Lack of a signed Informed Consent if the patient received and understood the information about the study.
2. Lack of a signed declaration by the responsible physician stating that no explicit opt-out advanced directives by the subject were known to be in place at the moment of inclusion if it had been impossible to inform the patient due to her/his state of consciousness and/or awareness of disease condition.

Trial design

1,500 participants in 6 patient groups

" Acute Ward Patients " care setting cohort

Description:

Acute Ward Hospitalised patients with suspected or known SARS-CoV-2 infection

" Nursing Homes (RSA) " care setting cohort

Description:

Nursing Home Resident Older Adult suffering from Suspected or known SARS-CoV-2 infection

" Home and Outpatients' Care " cohort

Description:

Outpatients at risk of SARS-CoV-2 infection

" Dementia Outpatients " cohort

Description:

Outpatients suffering from Dementia according to NIA-AA criteria, at risk of SARS-CoV-2 infection and on Treatment with anti-cholinesterase- dugs and/or anti-psychotics

" At home " cohort

Description:

Outpatients at risk of SARS-CoV-2 infection

" Outcomes " cohort

Description:

Age≥65 years as target population Hospitalised patients diagnosed with SARS-CoV-2 infection