Geriatric Population COVID-19 Observational Study (GEROCOVIDobs)

NCT04379440 | Unknown

• 1 other identifier: GC01-Obs
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 7

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.

Conditions

COVID-19

Keywords

Coronavirus Electronic Registry Geriatrics Best Practices

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• COVID-19 prevalent symptoms at onset

  Day0

• COVID-19 Prognostic Factors

  Day0

• Incidence of COVID-19 in the RSA cohort

  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

• Cognitive function in the "Dementia" and "At home " cohorts

  60 days or less in case of early termination

Study Arms (6)

" 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

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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:

You may not qualify if:

• Lack of a signed Informed Consent if the patient received and understood the information about the study.

Sponsors & Collaborators

• Raffaele Antonelli Incalzi: lead
• Italian Society of Gerontology and Geriatrics: collaborator
• BLUECOMPANION FRANCE: collaborator
• BLUECOMPANION LTD: collaborator

Study Sites (7)

RSA La Quiete

Castiglione Cosentino, Calabria, 87040, Italy

RECRUITING

ASP Catanzaro

Catanzaro Lido, Calabria, 88100, Italy

NOT YET RECRUITING

AOU Ferrara

Ferrara, Emilia-Romagna, 44124, Italy

NOT YET RECRUITING

Policlinico Campus Bio-Medico

Rome, Roma, 00128, Italy

RECRUITING

AOU Careggi

Florence, Tuscany, 50134, Italy

NOT YET RECRUITING

AOU Pisana Geriatria

Pisa, Tuscany, 56124, Italy

NOT YET RECRUITING

Ospedale di Comunita' ULSS 6 Euganea- COVID Center

Camposampiero, Veneto, 35012, Italy

RECRUITING

Related Publications (5)

• 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.

  PMID: 37202893 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.

  PMID: 35570723 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.

  PMID: 35227201 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.

  PMID: 34716570 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.

  PMID: 33573885 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Raffaele Antonelli Incalzi, M.D.

  Policlinico Campus Bio-Medico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susanna Del Signore, M.D.

CONTACT

+33676284080; susanna.ds@bluecompanion.eu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 60 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full Professor in Internal Medicine, Director of Geriatrics Department and Acting Director of Chronic Diseases Department

Study Record Dates

• First Submitted: May 3, 2020
• First Posted: May 7, 2020
• Study Start: April 25, 2020
• Primary Completion: September 30, 2020
• Study Completion: November 30, 2020
• Last Updated: May 7, 2020

Record last verified: 2020-05

Locations

IT (7)