FrailtyCOMETANCT05792891
Approaches and Metrics in Fraily Patients During COVID-19 Era
An observational study of Frailty and Oncology, run by Regina Elena Cancer Institute at 2 sites in Italy.
Trial summary
The COVID-19 pandemic started in December 2019 in Wuhan, the Chinese province of Hubei. Compared to the period of the first epidemic wave (March to May 2020), in the period of the second epidemic wave (October 2020 to July 2021), deceased people have a more significant clinical complexit, as demonstrated by the higher… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty, Oncology, Immune Deficiency
- What is being tested?
- Collecting biological material from frail patients, with or without COVID-19
- How many people
- 150 participants
- Where
- 2 sitesItaly
- Study dates
- 22 Dec 2020to 23 Nov 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Frail populations (patients with cancer, autoimmune disease, and immune deficiencies)
Who may be able to join
- Written informed consent for participation in the study
- In the period between April 1, 2021, and September 31, 2022, all COVID-19 positive frail patients identified by molecular swabs taken at participating institutions were included in the study; ii) on a quarterly basis, a cohort of equal numbers of COVID-19 negative frail patients wre identified and paired by disease , gender, and age.
Who cannot join
- No exclusion criteria were identified
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
"Regina Elena" National Cancer Institute
Rome, 00144
Regina Elena Cancer Institute
Rome, 00144
About this study
Official title: Development of Approaches and Metrics to Measure the Impact and Improve the Clinical Outcomes of Patients With Frailty in the Era of COVID-19.
The COVID-19 pandemic started in December 2019 in Wuhan, the Chinese province of Hubei. Compared to the period of the first epidemic wave (March to May 2020), in the period of the second epidemic wave (October 2020 to July 2021), deceased people have a more significant clinical complexit, as demonstrated by the higher number of comorbidities.The need to allocate significant amounts of healthcare resources to the COVID-19 emergency, deferral of routine healthcare visits, and invitation to avoid medical controls, if not strictly necessary, may have led to interruptions of disease management undersupply of chronic treatments. Consequently, the health status of patients with chronic pathologic conditions have worsened during and beyond the crisis. Patients with cancer, autoimmune disease, and immune deficiencies represented populations with varying immunocompetence, which made translate into higher susceptibility to SARS-CoV-2 and, for this reason, we defined them as frail populations.The main goal of the study was to propel the field of COVID-19 impact on particularly vulnerable categories of patients. The findings of this study could aid in determining the conditions under which healthcare organizations must operate in the event of a pandemic in order to protect patient's rights to care.
- Conditions
- Frailty, Oncology, Immune Deficiency
- Being tested
- Collecting biological material from frail patients, with or without COVID-19
- Medical subject headings
- Frailty, Neoplasms, Immunologic Deficiency Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collecting biological material from frail patients, with or without COVID-19Other
The study planned to collect demographic information, disease history, COVID-19 symptomatology, COVID-19 molecular test details, COVID-19 serological test results, and biobanking of biological specimens (PBMCs, sera, plasma). In addition, clinical analyses, anamnestic data, and pharmacological treatment pieces of information were collected.
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 patients | Not described Receives: Other: Collecting biological material from frail patients, with or without COVID-19 | |
| No Covid-19 patients | Not described Receives: Other: Collecting biological material from frail patients, with or without COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop general guidelines for clinical care of frail patients
Presence or not of SARS-COV2 infection Presence of specific tumor or HIV-1 infection or psoriasis
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start22 Dec 2020
- Primary completion15 Feb 2021
- Study completion23 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792891
- Sponsor's protocol ID
- RS1446
- Acronym
- COMETA
- Status last verified
- Mar 2023
- First submitted
- 24 Mar 2023
- Last updated
- 8 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Silvestris N, Belleudi V, Addis A, Pimpinelli F, Morrone A, Sciacchitano S, Mancini R, Garrisi VM, Costantini M, Ciliberto G, Frisardi V, Piaggio G. Development of Approaches and Metrics to Measure the Impact and Improve the Clinical Outcomes of Patients With Frailty in the Era of COVID-19. The COMETA Italian Protocol. Front Oncol. 2022 Jun 2;12:828660. doi: 10.3389/fonc.2022.828660. eCollection 2022.
PubMed 35756683
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Approaches and Metrics to Measure the Impact and Improve the Clinical Outcomes of Patients With Frailty in the Era of COVID-19.
- ClinicalTrials.gov ID
- NCT05792891
- Acronym / sponsor ID
- COMETA / RS1446
- Conditions
- Frailty, Oncology, Immune Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 23 Nov 2022 (actual)
- First posted
- 31 Mar 2023 (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 COVID-19 pandemic started in December 2019 in Wuhan, the Chinese province of Hubei. Compared to the period of the first epidemic wave (March to May 2020), in the period of the second epidemic wave (October 2020 to July 2021), deceased people have a more significant clinical complexit, as demonstrated by the higher number of comorbidities.The need to allocate significant amounts of healthcare resources to the COVID-19 emergency, deferral of routine healthcare visits, and invitation to avoid medical controls, if not strictly necessary, may have led to interruptions of disease management undersupply of chronic treatments. Consequently, the health status of patients with chronic pathologic conditions have worsened during and beyond the crisis. Patients with cancer, autoimmune disease, and immune deficiencies represented populations with varying immunocompetence, which made translate into higher susceptibility to SARS-CoV-2 and, for this reason, we defined them as frail populations.The main goal of the study was to propel the field of COVID-19 impact on particularly vulnerable categories of patients. The findings of this study could aid in determining the conditions under which healthcare organizations must operate in the event of a pandemic in order to protect patient's rights to care.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covid-19 patients | – | Other: Collecting biological material from frail patients, with or without COVID-19 |
| No Covid-19 patients | – | Other: Collecting biological material from frail patients, with or without COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Frail populations (patients with cancer, autoimmune disease, and immune deficiencies)
Key inclusion criteria (2 listed)
- Written informed consent for participation in the study
- In the period between April 1, 2021, and September 31, 2022, all COVID-19 positive frail patients identified by molecular swabs taken at participating institutions were included in the study; ii) on a quarterly basis, a cohort of equal numbers of COVID-19 negative frail patients wre identified and paired by disease , gender, and age.
Key exclusion criteria (1 listed)
- No exclusion criteria were identified
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 |
|---|---|---|
| Collecting biological material from frail patients, with or without COVID-19The study planned to collect demographic information, disease history, COVID-19 symptomatology, COVID-19 molecular test details, COVID-19 serological test results, and biobanking of biological specimens (PBMCs, sera, plasma). In addition, clinical analyses, anamnestic data, and pharmacological treatment pieces of information were collected. | Other | Covid-19 patients, No Covid-19 patients |
Primary outcome
Develop general guidelines for clinical care of frail patients
Time frame: 18 months
Presence or not of SARS-COV2 infection Presence of specific tumor or HIV-1 infection or psoriasis
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 8 May 2023.
- Results publication: PubMed 35756683Silvestris N, Belleudi V, Addis A, Pimpinelli F, Morrone A, Sciacchitano S, Mancini R, Garrisi VM, Costantini M, Ciliberto G, Frisardi V, Piaggio G. Development of Approaches and Metrics to Measure the Impact and Improve the Clinical Outcomes of Patients With Frailty in the Era of COVID-19. The COMETA Italian Protocol. Front Oncol. 2022 Jun 2;12:828660. doi: 10.3389/fonc.2022.828660. eCollection 2022.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and Oncology, run by Regina Elena Cancer Institute at 2 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 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Develop general guidelines for clinical care of frail patients (time frame: 18 months). 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 NCT05792891, which also lists 1 linked publication.
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 8 May 2023.