Frailty in Elderly Patients With COVID-19 — FRA-COVID  

Covid19 Clinical Trial

Official title: Relationship Between Frailty and Clinical Outcomes in Elderly Patients With COVID-19

Status Completed

Clinical Trial Summary

This is a multicentric retro-prospective observational study that wants to evaluate the relation between frailty and clinical outcomes in elderly patients with COVID-19.

Clinical Trial Description

BACKGROUND:

Assessment of frailty is today the best way to evaluate the biological age of the elderly person. Fragility can be defined as a syndrome selected by the reduction of organized reserves and by the decreased resistance to "stressors", resulting from the cumulative decline of multiple physiological systems that cause vulnerabilities and adverse consequences.

The impact of fragility on clinical outcomes has been investigated in numerous studies conducted on elderly patients in various care setting, proving in all of them a significant and more reliable predictor of variables such as age, comorbidity and individual pathologies, short and long-term mortality, length of stay and the onset of complications.

Previous studies have already shown that frail older adults have a greater susceptibility to viral infections (including non-COVID-19 coronavirus) due to a malfunction of their immune system.

The identification of fragility could therefore be particularly useful for identifying subjects at risk of negative outcomes (worsening of respiratory parameters, need for intubation, mortality) even in a ward with COVID + patients. In other words, the imperceptible clinical heterogeneity behind the age parameter could be better represented by a multidimensional parameter capable of measuring the accumulation of age-related deficits.

SAMPLE SIZE (n. patients):

The study plans to recruit 30 subjects per week on average; for an expected total of about 300 subjects for each participating site.

STUDY DESIGN:

The patient will be enrolled in the study when obtaining consent. In this phase the following data will be collected:

• date of birth

• gender

• demographic data

• comorbidity

• Brescia_COVID respiratory scale

• modified Early Warning Score

• delirium

• data relating to functional autonomy

• blood chemistry data at the entrance.

Using the variables that are part of the Comprehensive Geriatric Assessment, it will be possible to calculate the Frailty Index (FI), according to the Rockwood deficit accumulation model. A series of variables will then be collected relating to treatment procedures, therapies, the team's choice to maximize the care ceiling for the individual patient and the patient's clinical outcome.

Patients will be treated as per Normal Clinical Practice; no blood chemistry tests will be required in addition to the panel of tests provided by the hospital's health management for all patients with COVID-19.

Given the difficulty in systematically obtaining written informed consent and given the great public interest of the project, the research will be conducted in the context of the authorizations guaranteed by Article 89 of the GDPR EU Regulation 2016/679, which guarantees the treatment for purposes of public interest, scientific or historical research or statistical purposes of health data.

STATISTICAL ANALYSIS:

The FI will be built according to the Rockwood deficit accumulation model, taking into account a minimum number of variables that are part of the Comprehensive Geriatric Assessment. The FI will be obtained from the ratio between the number of pathological conditions present and the total number of indicators evaluated. Data from patients older than 60 years of age will be compared. ;

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Frailty

• NCT number: NCT04412265
• Study type: Observational
• Source: University of Milano Bicocca
• Status: Completed
• Start date: April 16, 2020
• Completion date: December 15, 2021