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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04379440
Recruitment Status : Unknown
Verified May 2020 by Raffaele Antonelli Incalzi, Campus Bio-Medico University.
Recruitment status was:  Recruiting
First Posted : May 7, 2020
Last Update Posted : May 7, 2020
Sponsor:
Collaborators:
Italian Society of Gerontology and Geriatrics
BLUECOMPANION FRANCE
BLUECOMPANION LTD
Information provided by (Responsible Party):
Raffaele Antonelli Incalzi, Campus Bio-Medico University

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.

Condition or disease
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 60 Days
Official Title: Geriatric Population COVID-19 Syndromic Characteristics and Clinical Outcomes: a Multi-setting, Multi-domain Observational Study (GEROCOVID Observational)
Actual Study Start Date : April 25, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Health status (WHO classification) [ Time Frame: 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).

  2. Incidence of Serious Adverse Events [ Time Frame: 60 days or less in case of early termination ]
    Incidence and duration of hospitalisation, incidence of Death and other Serious Adverse Events;


Secondary Outcome Measures :
  1. COVID-19 prevalent symptoms at onset [ Time Frame: Day0 ]
    Most frequent symptoms coded according MedDRA dictionary as reported at hospital admission

  2. COVID-19 Prognostic Factors [ Time Frame: Day0 ]
    Most frequent chronic diseases (coded according MedDRA dictionary) as reported at hospital admission per Outcome (death; Serious Adverse Event other than death).

  3. Incidence of COVID-19 in the RSA cohort [ Time Frame: 60 days or less in case of early termination ]
    Incidence of COVID-19 in the Nursing Homes (RSA) cohort per specific preventive measures application

  4. Affective/mood state change from baseline in the " At home " cohort [ Time Frame: 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

  5. Cognitive function in the "Dementia" and "At home " cohorts [ Time Frame: 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.

  6. Daily Life Function in the "Dementia" and "At home " cohorts [ Time Frame: 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)

  7. Instrumental Daily Life function in the "Dementia" and "At home " cohorts [ Time Frame: 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.

  8. Residual signs and symptoms in the " Outcomes " cohort [ Time Frame: 60 days or less in case of early termination ]
    Prevalence and pattern of residual signs and symptoms in the " Outcomes " cohort

  9. Incidence of outcomes in the " Outcomes " cohort per Frailty Status [ Time Frame: 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)

  10. Incidence of outcomes in the " Outcomes " cohort per Comorbidity burden at baseline [ Time Frame: 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04379440


Contacts
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Contact: Susanna Del Signore, M.D. +33676284080 susanna.ds@bluecompanion.eu

Locations
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Italy
RSA La Quiete Recruiting
Castiglione Cosentino, Calabria, Italy, 87040
ASP Catanzaro Not yet recruiting
Catanzaro Lido, Calabria, Italy, 88100
AOU Ferrara Not yet recruiting
Ferrara, Emilia Romagna, Italy, 44124
Policlinico Campus Bio-Medico Recruiting
Rome, Roma, Italy, 00128
AOU Careggi Not yet recruiting
Firenze, Toscana, Italy, 50134
AOU Pisana Geriatria Not yet recruiting
Pisa, Toscana, Italy, 56124
Ospedale di Comunita' ULSS 6 Euganea- COVID Center Recruiting
Camposampiero, Veneto, Italy, 35012
Sponsors and Collaborators
Raffaele Antonelli Incalzi
Italian Society of Gerontology and Geriatrics
BLUECOMPANION FRANCE
BLUECOMPANION LTD
Investigators
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Principal Investigator: Raffaele Antonelli Incalzi, M.D. Policlinico Campus Bio-Medico
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Raffaele Antonelli Incalzi, Full Professor in Internal Medicine, Director of Geriatrics Department and Acting Director of Chronic Diseases Department, Campus Bio-Medico University
ClinicalTrials.gov Identifier: NCT04379440    
Other Study ID Numbers: GC01-Obs
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Raffaele Antonelli Incalzi, Campus Bio-Medico University:
Coronavirus Electronic Registry Geriatrics Best Practices
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases