Geriatric Population COVID-19 Observational Study (GEROCOVIDobs)

COVID-19 Clinical Trial

— GEROCOVIDobs  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04379440
• Other study ID #: GC01-Obs
• Status: Recruiting
• Start date: April 25, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: May 2020
• Source: Campus Bio-Medico University
• Contact: Susanna Del Signore, M.D.
• Phone: +33676284080
• Email: susanna.ds[@]bluecompanion.eu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: November 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
Italy	Ospedale di Comunita' ULSS 6 Euganea- COVID Center	Camposampiero	Veneto
Italy	RSA La Quiete	Castiglione Cosentino	Calabria
Italy	ASP Catanzaro	Catanzaro Lido	Calabria
Italy	AOU Ferrara	Ferrara	Emilia Romagna
Italy	AOU Careggi	Firenze	Toscana
Italy	AOU Pisana Geriatria	Pisa	Toscana
Italy	Policlinico Campus Bio-Medico	Rome	Roma

Sponsors (4)

Lead Sponsor	Collaborator
Raffaele Antonelli Incalzi	BLUECOMPANION FRANCE, BLUECOMPANION LTD, Italian Society of Gerontology and Geriatrics

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	COVID-19 prevalent symptoms at onset	Most frequent symptoms coded according MedDRA dictionary as reported at hospital admission	Day0
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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