Approaches and Metrics in Fraily Patients During COVID-19 Era

Completed

• Conditions: Frailty; Immune Deficiency; Oncology
• Interventions: Other: Collecting biological material from frail patients, with or without COVID-19

• Registration Number: NCT05792891
• Lead Sponsor: Regina Elena Cancer Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-22
• Primary Completion: 2021-02-15
• Study Completion: 2022-11-23
• Status Verified: 2023-03
• Study First Submitted: 2023-03-24
• Study First Submitted QC: 2023-03-28
• Study First Posted: 2023-03-31
• Last Update Submitted: 2023-05-04
• Last Update Posted: 2023-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No Covid-19 patients	Collecting biological material from frail patients, with or without COVID-19	-
Covid-19 patients	Collecting biological material from frail patients, with or without COVID-19	-

Primary Outcome Measures

Name	Time	Method
Develop general guidelines for clinical care of frail patients	18 months	Presence or not of SARS-COV2 infection Presence of specific tumor or HIV-1 infection or psoriasis

Trial Locations

Locations (2)

Regina Elena Cancer Institute; 🇮🇹 Rome, Italy

"Regina Elena" National Cancer Institute; 🇮🇹 Rome, Italy