COVID-19NCT04348396
Clinical and Biological Predictors of COVID-19 Disease in Older Patients
An observational study of COVID-19, run by Istituto Nazionale di Ricovero e Cura per Anziani at 3 sites in Italy.
Trial summary
The project is an observational, prospective study. Its aim is to deepen our understanding of COVID-19 in older patients hospitalized and diagnosed with COVID-19. In particular, socioeconomic, diagnostic, biological, functional, therapy data will be collected at the patients' admission, during hospital stay, at the… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- COVID-19
- How many people
- 300 participants
- Where
- 3 sitesItaly
- Study dates
- 3 Apr 2020to 30 Apr 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients 65 years old and above hospitalized for COVID-19
Who may be able to join
- diagnosis of COVID-19
Who cannot join
- no informed consent
Trial locations and contacts
3 sites in 1 country.
Italy3 sites, 3 recruiting
- Recruiting
IRCCS INRCA Hospital
Ancona, 60129
Antonio Cherubini, MD, 00390718003537, a.cherubini@inrca.it
Antonio Cherubini, MD
- Recruiting
IRCCS INRCA Hospital
Casatenovo
Daniele Colombo, MD, d.colombo@inrca.it
Daniele Colombo, MD
- Recruiting
IRCCS INRCA Hospital
Fermo
Cinzia Giuli, c.giuli@inrca.it
Demetrio Postacchini, MD
About this study
Official title: ReportAge-COVID Project: Clinical and Biological Predictors of COVID-19 Disease in Older Patients
The project is an observational, prospective study. Its aim is to deepen our understanding of COVID-19 in older patients hospitalized and diagnosed with COVID-19.
In particular, socioeconomic, diagnostic, biological, functional, therapy data will be collected at the patients' admission, during hospital stay, at the discharge and 1, 3, 6, 12 months after discharge.
Results and findings will help support changes in clinical practice and decision making, with the aim to reduce the use of healthcare services and the healthcare expenditure.
Read the detailed description
Current knowledge about clinical and biological characteristics of COVID 19 among older people is very limited. A better comprehension of the clinical picture of older patients affected by COVID-19, (e.g. frailty, multimorbidity and polypharmacy patterns and functional performance) may significantly contribute to deepen our understanding of the clinical epidemiology knowledge of COVID-19 among hospitalized older people.
Therefore, the ReportAge-COVID project aims to collect - using a minimum clinical and biological data set - a series of data and indicators on the conditions of elderly patients that are suspected of having a compatible clinical picture or were confirmed positive for COVID-19. Data will be collected at the patients' admission, during hospital stay, at discharge and 1, 3, 6, 12 months after discharge.
In particular, the following specific pieces of information will be gathered:
- routinely collected demographic, socioeconomic, clinical, biological and diagnostic data
- frailty condition (by using the clinical frailty scale)
- assessment of the functional capacities through ADL and IADL tests
- health conditions; nutritional status; medications; treatments and procedures
- biomarkers of aging including cytokines and anti-inflammatory molecules, previously identified in a focus group of experts
Results and findings will help support changes in clinical practice and decision making, with the aim of reducing adverse outcomes, the worsening of health conditions in the elderly population, the use of healthcare services and, as a consequence, lower healthcare expenditure.
- Conditions
- COVID-19
- Keywords
- COVID-19, older people, SARS-CoV-2, frailty, physical function, biomarkers of inflammation
- Medical subject headings
- COVID-19, Frailty
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 |
|---|---|---|
| Elderly patients affected by COVID-19 | The group taken into consideration consists of elderly patients hospitalized with diagnosed COVID-19. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive-epidemiological analysis of health conditions
Collection of a set of data and indicators of the health conditions including personal data, clinical care, biological and diagnostic data, treatments/procedures and drug therapy
Measured: Patients will be followed for the duration of hospital stay, an expected average of 20 days
Secondary outcomes (6)
Evaluation of frailty condition
Clinical Frailty Scale (CFS). The CFS divides patients into 9 classes from very fit (CFS=1) to terminally ill (CFS=9)
Measured: At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge
Identification of biomarkers of inflammation
Analysis for IL6, IL-10, IL-2, IL-7, Alpha 1 Antitrypsin, IP10, MCP1, MIP1 alpha, TNF alpha, IFN alfa, IFN beta
Measured: At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge
Assessment of functional capacity
Activity of Daily Living (ADL). A summary score ranges from 0 (low function, dependent) to 6 (high function, independent)
Measured: At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge
Assessment of functional capacity
Activity of Instrumental of Daily Living (IADL). A summary score ranges from 0 (low function, dependent) to 8 (high function, independent)
Measured: At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge
Evaluation of drug consumption
Drugs prior to admission, drugs administered during hospital stay, prescribed drugs at discharge
Measured: At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge
Evaluation of inflamma-miRs
Determination of miR-21, miR-146a, miR-155
Measured: At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start3 Apr 2020
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348396
- Sponsor's protocol ID
- INRCA_01_2020
- Status last verified
- Oct 2023
- First submitted
- 10 Apr 2020
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ReportAge-COVID Project: Clinical and Biological Predictors of COVID-19 Disease in Older Patients
- ClinicalTrials.gov ID
- NCT04348396
- Acronym / sponsor ID
- INRCA_01_2020
- Conditions
- COVID-19
- Keywords
- COVID-19, older people, SARS-CoV-2, frailty, physical function, biomarkers of inflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Study start
- 3 Apr 2020 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 16 Apr 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 project is an observational, prospective study. Its aim is to deepen our understanding of COVID-19 in older patients hospitalized and diagnosed with COVID-19.
In particular, socioeconomic, diagnostic, biological, functional, therapy data will be collected at the patients' admission, during hospital stay, at the discharge and 1, 3, 6, 12 months after discharge.
Results and findings will help support changes in clinical practice and decision making, with the aim to reduce the use of healthcare services and the healthcare expenditure.
Detailed description
Current knowledge about clinical and biological characteristics of COVID 19 among older people is very limited. A better comprehension of the clinical picture of older patients affected by COVID-19, (e.g. frailty, multimorbidity and polypharmacy patterns and functional performance) may significantly contribute to deepen our understanding of the clinical epidemiology knowledge of COVID-19 among hospitalized older people.
Therefore, the ReportAge-COVID project aims to collect - using a minimum clinical and biological data set - a series of data and indicators on the conditions of elderly patients that are suspected of having a compatible clinical picture or were confirmed positive for COVID-19. Data will be collected at the patients' admission, during hospital stay, at discharge and 1, 3, 6, 12 months after discharge.
In particular, the following specific pieces of information will be gathered:
- routinely collected demographic, socioeconomic, clinical, biological and diagnostic data
- frailty condition (by using the clinical frailty scale)
- assessment of the functional capacities through ADL and IADL tests
- health conditions; nutritional status; medications; treatments and procedures
- biomarkers of aging including cytokines and anti-inflammatory molecules, previously identified in a focus group of experts
Results and findings will help support changes in clinical practice and decision making, with the aim of reducing adverse outcomes, the worsening of health conditions in the elderly population, the use of healthcare services and, as a consequence, lower healthcare expenditure.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly patients affected by COVID-19 | – | –The group taken into consideration consists of elderly patients hospitalized with diagnosed COVID-19. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients 65 years old and above hospitalized for COVID-19
Key inclusion criteria (1 listed)
- diagnosis of COVID-19
Key exclusion criteria (1 listed)
- no informed consent
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
Descriptive-epidemiological analysis of health conditions
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 20 days
Collection of a set of data and indicators of the health conditions including personal data, clinical care, biological and diagnostic data, treatments/procedures and drug therapy
6 secondary outcomes
Evaluation of frailty condition
Time frame: At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge
Identification of biomarkers of inflammation
Time frame: At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge
Assessment of functional capacity
Time frame: At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge
Assessment of functional capacity
Time frame: At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge
Evaluation of drug consumption
Time frame: At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge
Evaluation of inflamma-miRs
Time frame: At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- IRCCS INRCA websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
3 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 Istituto Nazionale di Ricovero e Cura per Anziani at 3 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 1 inclusion and 1 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 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Anna Rita Bonfigli, PhD (00390718003719, a.bonfigli@inrca.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive-epidemiological analysis of health conditions (time frame: Patients will be followed for the duration of hospital stay, an expected average of 20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2023.