Covid19FRA-COVIDNCT04412265
Frailty in Elderly Patients With COVID-19
An observational study of Covid19, run by University of Milano Bicocca at 6 sites in Italy.
Trial summary
This is a multicentric retro-prospective observational study that wants to evaluate the relation between frailty and clinical outcomes in elderly patients with COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Relation between frailty and clinical outcomes in elderly patients with COVID-19.
- How many people
- 1,344 participants
- Where
- 6 sitesItaly
- Study dates
- 16 Apr 2020to 15 Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be conducted on all patients hospitalized in COVID+ departments of the participating sites.
Who may be able to join
- Diagnosis of COVID related pneumonia
- Informed consent freely granted
Who cannot join
- Age less than 18 years
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
Dipartimento di Geriatria, Fondazione Poliambulanza
Brescia
Dipartimento di Medicina e Riabilitazione, Istituto Clinico Ospedale S. Anna
Brescia
UO Malattie Infettive, Spedali Civili
Brescia
UOC Medicina I a indirizzo Geriatrico, Spedali Civili
Montichiari
ASST Monza-Ospedale San Gerardo
Monza
SCDU Geriatria, AOU Città della Salute e della Scienza - Presidio Molinette
Torino
About this study
Official title: Relationship Between Frailty and Clinical Outcomes in Elderly Patients With COVID-19
This is a multicentric retro-prospective observational study that wants to evaluate the relation between frailty and clinical outcomes in elderly patients with COVID-19.
Read the detailed description
BACKGROUND:
Assessment of frailty is today the best way to evaluate the biological age of the elderly person. Fragility can be defined as a syndrome selected by the reduction of organized reserves and by the decreased resistance to "stressors", resulting from the cumulative decline of multiple physiological systems that cause vulnerabilities and adverse consequences.
The impact of fragility on clinical outcomes has been investigated in numerous studies conducted on elderly patients in various care setting, proving in all of them a significant and more reliable predictor of variables such as age, comorbidity and individual pathologies, short and long-term mortality, length of stay and the onset of complications.
Previous studies have already shown that frail older adults have a greater susceptibility to viral infections (including non-COVID-19 coronavirus) due to a malfunction of their immune system.
The identification of fragility could therefore be particularly useful for identifying subjects at risk of negative outcomes (worsening of respiratory parameters, need for intubation, mortality) even in a ward with COVID + patients. In other words, the imperceptible clinical heterogeneity behind the age parameter could be better represented by a multidimensional parameter capable of measuring the accumulation of age-related deficits.
SAMPLE SIZE (n. patients):
The study plans to recruit 30 subjects per week on average; for an expected total of about 300 subjects for each participating site.
STUDY DESIGN:
The patient will be enrolled in the study when obtaining consent. In this phase the following data will be collected:
- date of birth
- gender
- demographic data
- comorbidity
- Brescia_COVID respiratory scale
- modified Early Warning Score
- delirium
- data relating to functional autonomy
- blood chemistry data at the entrance.
Using the variables that are part of the Comprehensive Geriatric Assessment, it will be possible to calculate the Frailty Index (FI), according to the Rockwood deficit accumulation model. A series of variables will then be collected relating to treatment procedures, therapies, the team's choice to maximize the care ceiling for the individual patient and the patient's clinical outcome.
Patients will be treated as per Normal Clinical Practice; no blood chemistry tests will be required in addition to the panel of tests provided by the hospital's health management for all patients with COVID-19.
Given the difficulty in systematically obtaining written informed consent and given the great public interest of the project, the research will be conducted in the context of the authorizations guaranteed by Article 89 of the GDPR EU Regulation 2016/679, which guarantees the treatment for purposes of public interest, scientific or historical research or statistical purposes of health data.
STATISTICAL ANALYSIS:
The FI will be built according to the Rockwood deficit accumulation model, taking into account a minimum number of variables that are part of the Comprehensive Geriatric Assessment. The FI will be obtained from the ratio between the number of pathological conditions present and the total number of indicators evaluated. Data from patients older than 60 years of age will be compared.
- Conditions
- Covid19
- Being tested
- Relation between frailty and clinical outcomes in elderly patients with COVID-19.
- Keywords
- Coronavirus, sars-covid-2, coronavirus infection, geriatrics
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relation between frailty and clinical outcomes in elderly patients with COVID-19.Other
To evaluate whether a tool built to measure frailty in elderly patients hospitalized in COVID + hospital departments are more accurate in predicting clinical outcomes compared to a clinical evaluation based on age and comorbidity. If the assessment of fragility were actually more accurate, the tool developed could be implemented in hospitals to support the clinician 's choices regarding the "roof of care" and actions to be taken undertake to prevent deterioration.
| Study group | Role | What they receive |
|---|---|---|
| Covid 19 patients | The study will be conducted on all patients hospitalized affected by pneumonia COVID related. Receives: Other: Relation between frailty and clinical outcomes in elderly patients with COVID-19. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of a tool to measure frailty
The aim of the project is to evaluate whether a tool built to measure frailty in elderly patients admitted to the COVID + hospital wards is more accurate in predicting clinical states than a clinical evaluation developed on age and comorbidity.
Measured: Until patient discharge from the hospital (approximately 1 year).
Secondary outcomes (3)
A "proxy" variable of the fragility index can be built on the basis of regional administrative databases only.
Assess whether a "proxy" variable of the fragility index can be built on the basis of regional administrative databases only, which is able to predict the clinical outcomes of COVID + patients better than age and comorbidities alone.
Measured: Until patient discharge from the hospital (approximately 1 year).
Give elements to focus the screening policies for COVID19.
Relate different levels of chronicity with the susceptibility of the elderly subject to infection to give elements to focus the screening policies for COVID19.
Measured: Until patient discharge from the hospital (approximately 1 year).
Give the prevention of contagion at the elderly population level.
Relate different levels of chronicity with the susceptibility of the elderly subject to infection to prevent the contagion at the elderly population level.
Measured: Until patient discharge from the hospital (approximately 1 year).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start16 Apr 2020
- Primary completion30 Jun 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Retrospective
- Enrolment
- 1,344 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412265
- Sponsor's protocol ID
- FRA-COVID
- Acronym
- FRA-COVID
- Status last verified
- Apr 2022
- First submitted
- 30 May 2020
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.
PubMed 23395245Johnstone J, Parsons R, Botelho F, Millar J, McNeil S, Fulop T, McElhaney J, Andrew MK, Walter SD, Devereaux PJ, Malekesmaeili M, Brinkman RR, Mahony J, Bramson J, Loeb M. Immune biomarkers predictive of respiratory viral infection in elderly nursing home residents. PLoS One. 2014 Oct 2;9(9):e108481. doi: 10.1371/journal.pone.0108481. eCollection 2014.
PubMed 25275464Subbe CP, Kruger M, Rutherford P, Gemmel L. Validation of a modified Early Warning Score in medical admissions. QJM. 2001 Oct;94(10):521-6. doi: 10.1093/qjmed/94.10.521.
PubMed 11588210Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994.
PubMed 32167524Zucchelli A, Parigi M, Giliani S, Vetrano DL, Lucente D, Marzetti E, Calvani R, Bellelli G, Marengoni A. Older patients affected by COVID-19: investigating the existence of biological phenotypes. BMC Geriatr. 2024 Nov 7;24(1):923. doi: 10.1186/s12877-024-05473-5.
PubMed 39511501Trevisan C, Grande G, Rebora P, Zucchelli A, Valsecchi MG, Foca E, Ecarnot F, Marengoni A, Bellelli G. Early Onset Delirium During Hospitalization Increases In-Hospital and Postdischarge Mortality in COVID-19 Patients: A Multicenter Prospective Study. J Clin Psychiatry. 2023 Aug 21;84(5):22m14565. doi: 10.4088/JCP.22m14565.
PubMed 37616485
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Frailty and Clinical Outcomes in Elderly Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04412265
- Acronym / sponsor ID
- FRA-COVID / FRA-COVID
- Conditions
- Covid19
- Keywords
- Coronavirus, sars-covid-2, coronavirus infection, geriatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,344 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 2 Jun 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.
This is a multicentric retro-prospective observational study that wants to evaluate the relation between frailty and clinical outcomes in elderly patients with COVID-19.
Detailed description
BACKGROUND:
Assessment of frailty is today the best way to evaluate the biological age of the elderly person. Fragility can be defined as a syndrome selected by the reduction of organized reserves and by the decreased resistance to "stressors", resulting from the cumulative decline of multiple physiological systems that cause vulnerabilities and adverse consequences.
The impact of fragility on clinical outcomes has been investigated in numerous studies conducted on elderly patients in various care setting, proving in all of them a significant and more reliable predictor of variables such as age, comorbidity and individual pathologies, short and long-term mortality, length of stay and the onset of complications.
Previous studies have already shown that frail older adults have a greater susceptibility to viral infections (including non-COVID-19 coronavirus) due to a malfunction of their immune system.
The identification of fragility could therefore be particularly useful for identifying subjects at risk of negative outcomes (worsening of respiratory parameters, need for intubation, mortality) even in a ward with COVID + patients. In other words, the imperceptible clinical heterogeneity behind the age parameter could be better represented by a multidimensional parameter capable of measuring the accumulation of age-related deficits.
SAMPLE SIZE (n. patients):
The study plans to recruit 30 subjects per week on average; for an expected total of about 300 subjects for each participating site.
STUDY DESIGN:
The patient will be enrolled in the study when obtaining consent. In this phase the following data will be collected:
- date of birth
- gender
- demographic data
- comorbidity
- Brescia_COVID respiratory scale
- modified Early Warning Score
- delirium
- data relating to functional autonomy
- blood chemistry data at the entrance.
Using the variables that are part of the Comprehensive Geriatric Assessment, it will be possible to calculate the Frailty Index (FI), according to the Rockwood deficit accumulation model. A series of variables will then be collected relating to treatment procedures, therapies, the team's choice to maximize the care ceiling for the individual patient and the patient's clinical outcome.
Patients will be treated as per Normal Clinical Practice; no blood chemistry tests will be required in addition to the panel of tests provided by the hospital's health management for all patients with COVID-19.
Given the difficulty in systematically obtaining written informed consent and given the great public interest of the project, the research will be conducted in the context of the authorizations guaranteed by Article 89 of the GDPR EU Regulation 2016/679, which guarantees the treatment for purposes of public interest, scientific or historical research or statistical purposes of health data.
STATISTICAL ANALYSIS:
The FI will be built according to the Rockwood deficit accumulation model, taking into account a minimum number of variables that are part of the Comprehensive Geriatric Assessment. The FI will be obtained from the ratio between the number of pathological conditions present and the total number of indicators evaluated. Data from patients older than 60 years of age will be compared.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Covid 19 patients | – | Other: Relation between frailty and clinical outcomes in elderly patients with COVID-19.The study will be conducted on all patients hospitalized affected by pneumonia COVID related. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted on all patients hospitalized in COVID+ departments of the participating sites.
Key inclusion criteria (2 listed)
- Diagnosis of COVID related pneumonia
- Informed consent freely granted
Key exclusion criteria (1 listed)
- Age less than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relation between frailty and clinical outcomes in elderly patients with COVID-19.To evaluate whether a tool built to measure frailty in elderly patients hospitalized in COVID + hospital departments are more accurate in predicting clinical outcomes compared to a clinical evaluation based on age and comorbidity. If the assessment of fragility were actually more accurate, the tool developed could be implemented in hospitals to support the clinician 's choices regarding the "roof of care" and actions to be taken undertake to prevent deterioration. | Other | Covid 19 patients |
Primary outcome
Development of a tool to measure frailty
Time frame: Until patient discharge from the hospital (approximately 1 year).
The aim of the project is to evaluate whether a tool built to measure frailty in elderly patients admitted to the COVID + hospital wards is more accurate in predicting clinical states than a clinical evaluation developed on age and comorbidity.
3 secondary outcomes
A "proxy" variable of the fragility index can be built on the basis of regional administrative databases only.
Time frame: Until patient discharge from the hospital (approximately 1 year).
Give elements to focus the screening policies for COVID19.
Time frame: Until patient discharge from the hospital (approximately 1 year).
Give the prevention of contagion at the elderly population level.
Time frame: Until patient discharge from the hospital (approximately 1 year).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Background: PubMed 23395245Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.
- Background: PubMed 25275464Johnstone J, Parsons R, Botelho F, Millar J, McNeil S, Fulop T, McElhaney J, Andrew MK, Walter SD, Devereaux PJ, Malekesmaeili M, Brinkman RR, Mahony J, Bramson J, Loeb M. Immune biomarkers predictive of respiratory viral infection in elderly nursing home residents. PLoS One. 2014 Oct 2;9(9):e108481. doi: 10.1371/journal.pone.0108481. eCollection 2014.
- Background: PubMed 11588210Subbe CP, Kruger M, Rutherford P, Gemmel L. Validation of a modified Early Warning Score in medical admissions. QJM. 2001 Oct;94(10):521-6. doi: 10.1093/qjmed/94.10.521.
- Background: PubMed 32167524Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994.
- Derived from this study: PubMed 39511501Zucchelli A, Parigi M, Giliani S, Vetrano DL, Lucente D, Marzetti E, Calvani R, Bellelli G, Marengoni A. Older patients affected by COVID-19: investigating the existence of biological phenotypes. BMC Geriatr. 2024 Nov 7;24(1):923. doi: 10.1186/s12877-024-05473-5.
- Derived from this study: PubMed 37616485Trevisan C, Grande G, Rebora P, Zucchelli A, Valsecchi MG, Foca E, Ecarnot F, Marengoni A, Bellelli G. Early Onset Delirium During Hospitalization Increases In-Hospital and Postdischarge Mortality in COVID-19 Patients: A Multicenter Prospective Study. J Clin Psychiatry. 2023 Aug 21;84(5):22m14565. doi: 10.4088/JCP.22m14565.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by University of Milano Bicocca at 6 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 2 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: finished, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of a tool to measure frailty (time frame: Until patient discharge from the hospital (approximately 1 year).). 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 NCT04412265, which also lists 6 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 28 Apr 2022.