Geriatric Population COVID-19 Observational Study (GEROCOVIDobs)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Geriatric Population COVID-19 Syndromic Characteristics and Clinical Outcomes: a Multi-setting, Multi-domain Observational Study (GEROCOVID Observational)

Conditions
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COVID-19

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
|  Acute Ward Patients  care setting cohort<br>Acute Ward Hospitalised patients with suspected or known SARS-CoV-2 infection | |
|  Nursing Homes (RSA)  care setting cohort<br>Nursing Home Resident Older Adult suffering from Suspected or known SARS-CoV-2 infection | |
|  Home and Outpatients' Care  cohort<br>Outpatients at risk of SARS-CoV-2 infection | |
|  Dementia Outpatients  cohort<br>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<br>Outpatients at risk of SARS-CoV-2 infection | |
|  Outcomes  cohort<br>Age≥65 years as target population Hospitalised patients diagnosed with SARS-CoV-2 infection | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health status (WHO classification) | 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). | 60 days or less in case of early termination | 
| Incidence of Serious Adverse Events | Incidence and duration of hospitalisation, incidence of Death and other Serious Adverse Events; | 60 days or less in case of early termination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 prevalent symptoms at onset | Most frequent symptoms coded according MedDRA dictionary as reported at hospital admission | Day0 | 
| COVID-19 Prognostic Factors | Most frequent chronic diseases (coded according MedDRA dictionary) as reported at hospital admission per Outcome (death; Serious Adverse Event other than death). | Day0 | 
| Incidence of COVID-19 in the RSA cohort | Incidence of COVID-19 in the Nursing Homes (RSA) cohort per specific preventive measures application | 60 days or less in case of early termination | 
| Affective/mood state change from baseline in the  At home  cohort | Affective/mood state measured by the Geriatric Depression Scale 5-items (GDS-5) change from baseline; the GDS-5 ranges from 0 to 5, with scores>2 suggesting depression | 60 days or less in case of early termination | 
| Cognitive function in the Dementia and At home  cohorts | Mini Mental State Exam ( MMSE) change from baseline; the MMSE range from 0 to 30, with scores of 26 or higher being traditionally considered normal. Scores less than 9 generally indicate severe impairment, while scores between 10 and 20 indicate moderate dementia. | 60 days or less in case of early termination | 
| Daily Life Function in the Dementia and At home  cohorts | Activities of Daily Life rating scale ( ADL) change from baseline; the ADL range from 6 to 0, 6 = High (patient independent) 0 = Low (patient very dependent) | 60 days or less in case of early termination | 
| Instrumental Daily Life function in the Dementia and At home  cohorts | Instrumental Activities of Daily Life rating scale ( iADL) change from baseline; the iADL summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men to avoid potential gender bias. | 60 days or less in case of early termination | 
| Residual signs and symptoms in the  Outcomes  cohort | Prevalence and pattern of 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 Frailty Status | Incidence of Death, Hospitalisation, Hospitalisation days, number of Serious Adverse Events) per Frailty Status at baseline (Fried's anamnestic criteria, adapted) | 60 days or less in case of early termination | 
| Incidence of outcomes in the  Outcomes  cohort per Comorbidity burden at baseline | Incidence of outcomes (Death, Hospitalisation, Hospitalisation days, number of Serious Adverse Events) per Comorbidity Burden at baseline (CIRS) | 60 days or less in case of early termination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronavirus Electronic Registry Geriatrics Best Practices