NCT05792891

Approaches and Metrics in Fraily Patients During COVID-19 Era

Development of Approaches and Metrics to Measure the Impact and Improve the Clinical Outcomes of Patients With Frailty in the Era of COVID-19.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Regina Elena Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Frailty
• Oncology
• Immune Deficiency

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-12-22
• Primary completion: 2021-02-15
• Completion: 2022-11-23
• First posted: 2023-03-31
• Last updated: 2023-05-08

Locations

2 sites across 1 country: Italy