Geriatric Population COVID-19 Observational Study (GEROCOVIDobs)

NCT ID: NCT04379440

Last Updated: 2020-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-25

Study Completion Date

2020-11-30

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.

Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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" Acute Ward Patients " care setting cohort

Acute Ward Hospitalised patients with suspected or known SARS-CoV-2 infection

No interventions assigned to this group

" Nursing Homes (RSA) " care setting cohort

Nursing Home Resident Older Adult suffering from Suspected or known SARS-CoV-2 infection

No interventions assigned to this group

" Home and Outpatients' Care " cohort

Outpatients at risk of SARS-CoV-2 infection

No interventions assigned to this group

" 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

No interventions assigned to this group

" At home " cohort

Outpatients at risk of SARS-CoV-2 infection

No interventions assigned to this group

" Outcomes " cohort

Age≥65 years as target population Hospitalised patients diagnosed with SARS-CoV-2 infection

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Italian Society of Gerontology and Geriatrics

UNKNOWN

Sponsor Role collaborator

BLUECOMPANION FRANCE

UNKNOWN

Sponsor Role collaborator

BLUECOMPANION LTD

UNKNOWN

Sponsor Role collaborator

Raffaele Antonelli Incalzi

OTHER

Sponsor Role lead

Responsible Party

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Raffaele Antonelli Incalzi

Full Professor in Internal Medicine, Director of Geriatrics Department and Acting Director of Chronic Diseases Department

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Raffaele Antonelli Incalzi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Policlinico Campus Bio-Medico

Locations

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RSA La Quiete

Castiglione Cosentino, Calabria, Italy

Site Status RECRUITING

ASP Catanzaro

Catanzaro Lido, Calabria, Italy

Site Status NOT_YET_RECRUITING

AOU Ferrara

Ferrara, Emilia-Romagna, Italy

Site Status NOT_YET_RECRUITING

Policlinico Campus Bio-Medico

Rome, Roma, Italy

Site Status RECRUITING

AOU Careggi

Florence, Tuscany, Italy

Site Status NOT_YET_RECRUITING

AOU Pisana Geriatria

Pisa, Tuscany, Italy

Site Status NOT_YET_RECRUITING

Ospedale di Comunita' ULSS 6 Euganea- COVID Center

Camposampiero, Veneto, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Susanna Del Signore, M.D.

Role: CONTACT

+33676284080

References

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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.

Reference Type DERIVED
PMID: 37202893 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35570723 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35227201 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34716570 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33573885 (View on PubMed)

Other Identifiers

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GC01-Obs

Identifier Type: -

Identifier Source: org_study_id

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