Frailty Clinical Trial
— COMETAOfficial 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.
NCT number | NCT05792891 |
Other study ID # | RS1446 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 22, 2020 |
Est. completion date | November 23, 2022 |
Verified date | March 2023 |
Source | Regina Elena Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | November 23, 2022 |
Est. primary completion date | February 15, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - No exclusion criteria were identified |
Country | Name | City | State |
---|---|---|---|
Italy | "Regina Elena" National Cancer Institute | Rome | |
Italy | Regina Elena Cancer Institute | Rome |
Lead Sponsor | Collaborator |
---|---|
Regina Elena Cancer Institute |
Italy,
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 18 months |
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