Approaches and Metrics in Fraily Patients During COVID-19 Era

Frailty Clinical Trial

— COMETA  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05792891
• Other study ID #: RS1446
• Status: Completed
• Start date: December 22, 2020
• Est. completion date: November 23, 2022

Study information

• Verified date: March 2023
• Source: Regina Elena Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Frailty
• Immune Deficiency
• Immunologic Deficiency Syndromes
• Oncology

Intervention

Other:
• Collecting biological material from frail patients, with or without COVID-19
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.

Locations

Country	Name	City	State
Italy	"Regina Elena" National Cancer Institute	Rome
Italy	Regina Elena Cancer Institute	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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

Outcome

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