Geriatric Population COVID-19 Observational Study (GEROCOVIDobs)

R

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

Applying only to the " Acute Ward Patients " cohort:

  • Hospitalised patients
  • Suspected or known SARS-CoV-2 infection

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

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

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

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

Applying only to the" Dementia outpatients " cohort:

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

Applying only to the" At home " cohort:

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

Applying only to the " Outcomes " cohort:

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

Exclusion criteria

  • Lack of a signed Informed Consent if the patient received and understood the information about the study.
  • 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

Trial contacts and locations

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Central trial contact

Susanna Del Signore, M.D.

Data sourced from clinicaltrials.gov

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