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| Name | Class |
|---|---|
| Italian Society of Gerontology and Geriatrics | UNKNOWN |
| BLUECOMPANION FRANCE | UNKNOWN |
| BLUECOMPANION LTD | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| " Acute Ward Patients " care setting cohort | Acute Ward Hospitalised patients with suspected or known SARS-CoV-2 infection | ||
| " Nursing Homes (RSA) " care setting cohort | Nursing Home Resident Older Adult suffering from Suspected or known SARS-CoV-2 infection | ||
| " Home and Outpatients' Care " cohort | Outpatients at risk of SARS-CoV-2 infection | ||
| " Dementia Outpatients " cohort | 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 | Outpatients at risk of SARS-CoV-2 infection | ||
| " Outcomes " cohort | Age≥65 years as target population Hospitalised patients diagnosed with SARS-CoV-2 infection |
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| 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 |
| 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). |
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Inclusion Criteria:
Applying only to the " Acute Ward Patients " cohort:
Applying only to the "Nursing Homes (RSA)" cohort:
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:
Applying only to the" At home " cohort:
a. Outpatients at risk of SARS-CoV-2 infection
Applying only to the " Outcomes " cohort:
Exclusion Criteria:
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All sequentially observed cases since the start of the registry at the Investigational Centre. The registry can be started on 1st March 2020 at the earliest.
Older adults theoretically at risk of COVID-19
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susanna Del Signore, M.D. | Contact | +33676284080 | susanna.ds@bluecompanion.eu |
| Name | Affiliation | Role |
|---|---|---|
| Raffaele Antonelli Incalzi, M.D. | Policlinico Campus Bio-Medico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RSA La Quiete | Recruiting | Castiglione Cosentino | Calabria | 87040 | Italy | |
| ASP Catanzaro |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37202893 | Derived | Gareri P, Trevisan C, Abbatecola AM, Malara A, Incalzi RA. Efficacy of OM-85 in Recurrent Respiratory Tract Infections. Rev Recent Clin Trials. 2023;18(3):223-227. doi: 10.2174/1574887118666230518112806. | |
| 35570723 | Derived | Trevisan C, Remelli F, Fumagalli S, Mossello E, Okoye C, Bellelli G, Coin A, Malara A, Gareri P, Monzani F, Del Signore S, Zia G, Antonelli Incalzi R, Volpato S; GeroCovid Acute Ward Working Group. COVID-19 as a Paradigmatic Model of the Heterogeneous Disease Presentation in Older People: Data from the GeroCovid Observational Study. Rejuvenation Res. 2022 Jun;25(3):129-140. doi: 10.1089/rej.2021.0063. Epub 2022 Jun 6. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| 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 |
| Not yet recruiting |
| Catanzaro Lido |
| Calabria |
| 88100 |
| Italy |
| AOU Ferrara | Not yet recruiting | Ferrara | Emilia-Romagna | 44124 | Italy |
| Policlinico Campus Bio-Medico | Recruiting | Rome | Roma | 00128 | Italy |
| AOU Careggi | Not yet recruiting | Florence | Tuscany | 50134 | Italy |
| AOU Pisana Geriatria | Not yet recruiting | Pisa | Tuscany | 56124 | Italy |
| Ospedale di Comunita' ULSS 6 Euganea- COVID Center | Recruiting | Camposampiero | Veneto | 35012 | Italy |
| 35227201 | Derived | Okoye C, Finamore P, Bellelli G, Coin A, Del Signore S, Fumagalli S, Gareri P, Malara A, Mossello E, Trevisan C, Volpato S, Zia G, Monzani F, Incalzi RA. Computed tomography findings and prognosis in older COVID-19 patients. BMC Geriatr. 2022 Mar 1;22(1):166. doi: 10.1186/s12877-022-02837-7. |
| 34716570 | Derived | Fumagalli S, Trevisan C, Del Signore S, Pelagalli G, Fumagalli C, Herbst A, Volpato S, Gareri P, Mossello E, Malara A, Monzani F, Okoye C, Coin A, Bellelli G, Zia G, Ungar A, Ranhoff AH, Antonelli Incalzi R; GeroCovid Working Group. Atrial fibrillation and COVID-19 in older patients: how disability contributes to shape the risk profile. An analysis of the GeroCovid registry. Aging Clin Exp Res. 2022 Jan;34(1):249-256. doi: 10.1007/s40520-021-02008-5. Epub 2021 Oct 30. |
| 33573885 | Derived | Trevisan C, Del Signore S, Fumagalli S, Gareri P, Malara A, Mossello E, Volpato S, Monzani F, Coin A, Bellelli G, Zia G, Ranhoff AH, Antonelli Incalzi R; GeroCovid Working Group. Assessing the impact of COVID-19 on the health of geriatric patients: The European GeroCovid Observational Study. Eur J Intern Med. 2021 May;87:29-35. doi: 10.1016/j.ejim.2021.01.017. Epub 2021 Jan 31. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |