Geriatric Population COVID-19 Syndromic Characteristics and Clinical Outcomes: a Multi-setting, Multi-domain Observational Study (GEROCOVID Observational)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Raffaele Antonelli Incalzi
- Enrollment
- 1500
- Locations
- 7
- Primary Endpoint
- Incidence of Serious Adverse Events
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Raffaele Antonelli Incalzi
Full Professor in Internal Medicine, Director of Geriatrics Department and Acting Director of Chronic Diseases Department
Campus Bio-Medico University
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Incidence of Serious Adverse Events
Time Frame: 60 days or less in case of early termination
Incidence and duration of hospitalisation, incidence of Death and other Serious Adverse Events;
Health status (WHO classification)
Time Frame: 60 days or less in case of early termination
Change of health status according to WHO classification versus baseline after 60 days, or after any interval (last performed observation) in the event of early study termination (whole sample).
Secondary Outcomes
- Incidence of outcomes in the " Outcomes " cohort per Frailty Status(60 days or less in case of early termination)
- COVID-19 prevalent symptoms at onset(Day0)
- Instrumental Daily Life function in the "Dementia" and "At home " cohorts(60 days or less in case of early termination)
- Incidence of COVID-19 in the RSA cohort(60 days or less in case of early termination)
- COVID-19 Prognostic Factors(Day0)
- Cognitive function in the "Dementia" and "At home " cohorts(60 days or less in case of early termination)
- Affective/mood state change from baseline in the " At home " cohort(60 days or less in case of early termination)
- Residual signs and symptoms in the " Outcomes " cohort(60 days or less in case of early termination)
- Incidence of outcomes in the " Outcomes " cohort per Comorbidity burden at baseline(60 days or less in case of early termination)
- Daily Life Function in the "Dementia" and "At home " cohorts(60 days or less in case of early termination)