Approaches and Metrics in Fraily Patients During COVID-19 Era (COMETA)

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.

Study Overview

• Status: Completed
• Conditions: Frailty; Oncology; Immune Deficiency
• Intervention / Treatment: Other: Collecting biological material from frail patients, with or without COVID-19

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00144
    • "Regina Elena" National Cancer Institute
  • Rome, Italy, 00144
    • Regina Elena Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Frail populations (patients with cancer, autoimmune disease, and immune deficiencies)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Covid-19 patients	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.
No Covid-19 patients	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Regina Elena Cancer Institute

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2020
• Primary Completion (Actual): February 15, 2021
• Study Completion (Actual): November 23, 2022

Study Registration Dates

• First Submitted: March 24, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Frailty; Immunologic Deficiency Syndromes
• Other Study ID Numbers: RS1446

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No