Clinical trial NCT04379440: Geriatric Population COVID-19 Observational Study (GEROCOVIDobs)
Official title: Geriatric Population COVID-19 Syndromic Characteristics and Clinical Outcomes: a Multi-setting, Multi-domain Observational Study (GEROCOVID Observational)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: Coronavirus Electronic Registry Geriatrics Best Practices
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
Collaborators: name: Italian Society of Gerontology and Geriatrics
name: BLUECOMPANION FRANCE
name: BLUECOMPANION LTD
First posted: 2020-05-07
Enrollment: 1500
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Health status (WHO classification)
timeFrame: 60 days or less in case of early termination
measure: Incidence of Serious Adverse Events
timeFrame: 60 days or less in case of early termination
Secondary outcomes:
measure: COVID-19 prevalent symptoms at onset
timeFrame: Day0
measure: COVID-19 Prognostic Factors
timeFrame: Day0
measure: Incidence of COVID-19 in the RSA cohort
timeFrame: 60 days or less in case of early termination
measure: Affective/mood state change from baseline in the " At home " cohort
timeFrame: 60 days or less in case of early termination
measure: Cognitive function in the "Dementia" and "At home " cohorts
timeFrame: 60 days or less in case of early termination
measure: Daily Life Function in the "Dementia" and "At home " cohorts
timeFrame: 60 days or less in case of early termination
measure: Instrumental Daily Life function in the "Dementia" and "At home " cohorts
timeFrame: 60 days or less in case of early termination
measure: Residual signs and symptoms in the " Outcomes " cohort
timeFrame: 60 days or less in case of early termination
measure: Incidence of outcomes in the " Outcomes " cohort per Frailty Status
timeFrame: 60 days or less in case of early termination
measure: Incidence of outcomes in the " Outcomes " cohort per Comorbidity burden at baseline
timeFrame: 60 days or less in case of early termination
Other outcomes:
Locations:
city: Castiglione Cosentino
country: Italy
facility: RSA La Quiete
state: Calabria
city: Catanzaro Lido
country: Italy
facility: ASP Catanzaro
state: Calabria
city: Ferrara
country: Italy
facility: AOU Ferrara
state: Emilia Romagna
city: Rome
country: Italy
facility: Policlinico Campus Bio-Medico
state: Roma
city: Firenze
country: Italy
facility: AOU Careggi
state: Toscana
city: Pisa
country: Italy
facility: AOU Pisana Geriatria
state: Toscana
city: Camposampiero
country: Italy
facility: Ospedale di Comunita' ULSS 6 Euganea- COVID Center
state: Veneto
Study officials:
affiliation: Policlinico Campus Bio-Medico
name: Raffaele Antonelli Incalzi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.