Geriatric Population COVID-19 Observational Study (GEROCOVIDobs) (GEROCOVIDobs)

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

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.

Study Overview

• Status: Unknown
• Conditions: COVID-19

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.

• Study Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

• Study Contact: Name: Susanna Del Signore, M.D.; Phone Number: +33676284080; Email: susanna.ds@bluecompanion.eu

Study Locations

• Italy
  • Calabria
    • Castiglione Cosentino, Calabria, Italy, 87040
      • Recruiting
      • RSA La Quiete
    • Catanzaro Lido, Calabria, Italy, 88100
      • Not yet recruiting
      • ASP Catanzaro
  • Emilia Romagna
    • Ferrara, Emilia Romagna, Italy, 44124
      • Not yet recruiting
      • AOU Ferrara
  • Roma
    • Rome, Roma, Italy, 00128
      • Recruiting
      • Policlinico Campus Bio-Medico
  • Toscana
    • Firenze, Toscana, Italy, 50134
      • Not yet recruiting
      • AOU Careggi
    • Pisa, Toscana, Italy, 56124
      • Not yet recruiting
      • AOU Pisana Geriatria
  • Veneto
    • Camposampiero, Veneto, Italy, 35012
      • Recruiting
      • Ospedale di Comunita' ULSS 6 Euganea- COVID Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort
" 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Raffaele Antonelli Incalzi
• Collaborators: Italian Society of Gerontology and Geriatrics; BLUECOMPANION FRANCE; BLUECOMPANION LTD
• Investigators: Principal Investigator: Raffaele Antonelli Incalzi, M.D., Policlinico Campus Bio-Medico

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 25, 2020
• Primary Completion (ANTICIPATED): September 30, 2020
• Study Completion (ANTICIPATED): November 30, 2020

Study Registration Dates

• First Submitted: May 3, 2020
• First Submitted That Met QC Criteria: May 6, 2020
• First Posted (ACTUAL): May 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 7, 2020
• Last Update Submitted That Met QC Criteria: May 6, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Coronavirus Electronic Registry Geriatrics Best Practices
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: GC01-Obs

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No