COVID-19GEROCOVIDobsNCT04379440
Geriatric Population COVID-19 Observational Study (GEROCOVIDobs)
An observational study of COVID-19, run by Raffaele Antonelli Incalzi at 7 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- COVID-19
- How many people
- 1,500 participants
- Where
- 7 sitesItaly
- Study dates
- 25 Apr 2020to 30 Nov 2020
- How long will I take part?
- 60 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Show all 17Show fewer
- Applying only to the" Home and outpatients' care " cohort:
- 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:
- Outpatients at risk of SARS-CoV-2 infection
- Applying only to the " Outcomes " cohort:
- Age≥65 years
- Hospitalised patients diagnosed with SARS-CoV-2 infection
Who cannot join
- Lack of a signed Informed Consent if the patient received and understood the information about the study.
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites, 7 recruiting
- Recruiting
Ospedale di Comunita' ULSS 6 Euganea- COVID Center
Camposampiero, Veneto, 35012
- Recruiting
RSA La Quiete
Castiglione Cosentino, Calabria, 87040
- Not yet recruiting
ASP Catanzaro
Catanzaro Lido, Calabria, 88100
- Not yet recruiting
AOU Ferrara
Ferrara, Emilia-Romagna, 44124
- Not yet recruiting
AOU Careggi
Florence, Tuscany, 50134
- Not yet recruiting
AOU Pisana Geriatria
Pisa, Tuscany, 56124
- Recruiting
Policlinico Campus Bio-Medico
Rome, Roma, 00128
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19
- Keywords
- Coronavirus Electronic Registry Geriatrics Best Practices
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| " 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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;
Measured: 60 days or less in case of early termination
Secondary outcomes (10)
COVID-19 prevalent symptoms at onset
Most frequent symptoms coded according MedDRA dictionary as reported at hospital admission
Measured: 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).
Measured: Day0
Incidence of COVID-19 in the RSA cohort
Incidence of COVID-19 in the Nursing Homes (RSA) cohort per specific preventive measures application
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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)
Measured: 60 days or less in case of early termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start25 Apr 2020
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 60 Days
Sponsor and investigators
- Lead sponsor
- Raffaele Antonelli Incalzi
- Sponsor type
- University, hospital or other
- Collaborators
- Italian Society of Gerontology and Geriatrics, BLUECOMPANION FRANCE, BLUECOMPANION LTD
- Responsible party
- Sponsor-investigator, Raffaele Antonelli Incalzi, Campus Bio-Medico University
- Investigators
- Raffaele Antonelli Incalzi, M.D., Principal investigator, Policlinico Campus Bio-Medico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379440
- Sponsor's protocol ID
- GC01-Obs
- Acronym
- GEROCOVIDobs
- Status last verified
- May 2020
- First submitted
- 3 May 2020
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37202893Trevisan 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.
PubMed 35570723Okoye 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.
PubMed 35227201Fumagalli 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.
PubMed 34716570Trevisan 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.
PubMed 33573885
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geriatric Population COVID-19 Syndromic Characteristics and Clinical Outcomes: a Multi-setting, Multi-domain Observational Study (GEROCOVID Observational)
- ClinicalTrials.gov ID
- NCT04379440
- Acronym / sponsor ID
- GEROCOVIDobs / GC01-Obs
- Conditions
- COVID-19
- Keywords
- Coronavirus Electronic Registry Geriatrics Best Practices
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Raffaele Antonelli IncalziUniversity, hospital or other
- Collaborators
- Italian Society of Gerontology and Geriatrics, BLUECOMPANION FRANCE, BLUECOMPANION LTD
- Study start
- 25 Apr 2020 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 60 Days
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| " 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (17 listed)
- Applying only to the " Acute Ward Patients " cohort:
- Applying only to the "Nursing Homes (RSA)" cohort:
- Applying only to the" Home and outpatients' care " cohort:
- Applying only to the" Dementia outpatients " cohort:
- Applying only to the" At home " cohort:
Key exclusion criteria (2 listed)
- Lack of a signed Informed Consent if the patient received and understood the information about the study.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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;
10 secondary outcomes
COVID-19 prevalent symptoms at onset
Time frame: Day0
COVID-19 Prognostic Factors
Time frame: Day0
Incidence of COVID-19 in the RSA cohort
Time frame: 60 days or less in case of early termination
Affective/mood state change from baseline in the " At home " cohort
Time frame: 60 days or less in case of early termination
Cognitive function in the "Dementia" and "At home " cohorts
Time frame: 60 days or less in case of early termination
Daily Life Function in the "Dementia" and "At home " cohorts
Time frame: 60 days or less in case of early termination
Instrumental Daily Life function in the "Dementia" and "At home " cohorts
Time frame: 60 days or less in case of early termination
Residual signs and symptoms in the " Outcomes " cohort
Time frame: 60 days or less in case of early termination
Incidence of outcomes in the " Outcomes " cohort per Frailty Status
Time frame: 60 days or less in case of early termination
Incidence of outcomes in the " Outcomes " cohort per Comorbidity burden at baseline
Time frame: 60 days or less in case of early termination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Derived from this study: PubMed 37202893Gareri 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.
- Derived from this study: PubMed 35570723Trevisan 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.
- Derived from this study: PubMed 35227201Okoye 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.
- Derived from this study: PubMed 34716570Fumagalli 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.
- Derived from this study: PubMed 33573885Trevisan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raffaele Antonelli Incalzi, M.D. principal investigator
Policlinico Campus Bio-Medico
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Raffaele Antonelli Incalzi at 7 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susanna Del Signore, M.D. (+33676284080, susanna.ds@bluecompanion.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health status (WHO classification) (time frame: 60 days or less in case of early termination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04379440, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2020.