Geriatric Population COVID-19 Observational Study (GEROCOVIDobs)

• Conditions: COVID-19

• Registration Number: NCT04379440
• Lead Sponsor: Raffaele Antonelli Incalzi

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.

Study Timeline

• Study Start: 2020-04-25
• Status Verified: 2020-05
• Study First Submitted: 2020-05-03
• Study First Submitted QC: 2020-05-06
• Last Update Submitted: 2020-05-06
• Study First Posted: 2020-05-07
• Last Update Posted: 2020-05-07
• Primary Completion: 2020-09-30
• Study Completion: 2020-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Serious Adverse Events	60 days or less in case of early termination	Incidence and duration of hospitalisation, incidence of Death and other Serious Adverse Events;
Health status (WHO classification)	60 days or less in case of early termination	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).

Secondary Outcome Measures

Name	Time	Method
COVID-19 prevalent symptoms at onset	Day0	Most frequent symptoms coded according MedDRA dictionary as reported at hospital admission
Instrumental Daily Life function in the "Dementia" and "At home " cohorts	60 days or less in case of early termination	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.
Incidence of outcomes in the " Outcomes " cohort per Frailty Status	60 days or less in case of early termination	Incidence of Death, Hospitalisation, Hospitalisation days, number of Serious Adverse Events) per Frailty Status at baseline (Fried's anamnestic criteria, adapted)
Cognitive function in the "Dementia" and "At home " cohorts	60 days or less in case of early termination	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.
COVID-19 Prognostic Factors	Day0	Most frequent chronic diseases (coded according MedDRA dictionary) as reported at hospital admission per Outcome (death; Serious Adverse Event other than death).
Incidence of COVID-19 in the RSA cohort	60 days or less in case of early termination	Incidence of COVID-19 in the Nursing Homes (RSA) cohort per specific preventive measures application
Affective/mood state change from baseline in the " At home " cohort	60 days or less in case of early termination	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
Residual signs and symptoms in the " Outcomes " cohort	60 days or less in case of early termination	Prevalence and pattern of residual signs and symptoms in the " Outcomes " cohort
Incidence of outcomes in the " Outcomes " cohort per Comorbidity burden at baseline	60 days or less in case of early termination	Incidence of outcomes (Death, Hospitalisation, Hospitalisation days, number of Serious Adverse Events) per Comorbidity Burden at baseline (CIRS)
Daily Life Function in the "Dementia" and "At home " cohorts	60 days or less in case of early termination	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)

Trial Locations

Locations (7)

RSA La Quiete; 🇮🇹 Castiglione Cosentino, Calabria, Italy

ASP Catanzaro; 🇮🇹 Catanzaro Lido, Calabria, Italy

AOU Ferrara; 🇮🇹 Ferrara, Emilia Romagna, Italy

Policlinico Campus Bio-Medico; 🇮🇹 Rome, Roma, Italy

Ospedale di Comunita' ULSS 6 Euganea- COVID Center; 🇮🇹 Camposampiero, Veneto, Italy

AOU Pisana Geriatria; 🇮🇹 Pisa, Toscana, Italy

AOU Careggi; 🇮🇹 Firenze, Toscana, Italy