Clinical and Biological Predictors of COVID-19 Disease in Older Patients

COVID-19 Clinical Trial

Official title:

ReportAge-COVID Project: Clinical and Biological Predictors of COVID-19 Disease in Older Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04348396
• Other study ID #: INRCA_01_2020
• Status: Recruiting
• Start date: April 3, 2020
• Est. completion date: April 30, 2024

Study information

• Verified date: October 2023
• Source: Istituto Nazionale di Ricovero e Cura per Anziani
• Contact: Anna Rita Bonfigli, PhD
• Phone: 00390718003719
• Email: a.bonfigli[@]inrca.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The project is an observational, prospective study. Its aim is to deepen our understanding of COVID-19 in older patients hospitalized and diagnosed with COVID-19.

In particular, socioeconomic, diagnostic, biological, functional, therapy data will be collected at the patients' admission, during hospital stay, at the discharge and 1, 3, 6, 12 months after discharge.

Results and findings will help support changes in clinical practice and decision making, with the aim to reduce the use of healthcare services and the healthcare expenditure.

Description:

Current knowledge about clinical and biological characteristics of COVID 19 among older people is very limited. A better comprehension of the clinical picture of older patients affected by COVID-19, (e.g. frailty, multimorbidity and polypharmacy patterns and functional performance) may significantly contribute to deepen our understanding of the clinical epidemiology knowledge of COVID-19 among hospitalized older people.

Therefore, the ReportAge-COVID project aims to collect - using a minimum clinical and biological data set - a series of data and indicators on the conditions of elderly patients that are suspected of having a compatible clinical picture or were confirmed positive for COVID-19. Data will be collected at the patients' admission, during hospital stay, at discharge and 1, 3, 6, 12 months after discharge.

In particular, the following specific pieces of information will be gathered:

• routinely collected demographic, socioeconomic, clinical, biological and diagnostic data

• frailty condition (by using the clinical frailty scale)

• assessment of the functional capacities through ADL and IADL tests

• health conditions; nutritional status; medications; treatments and procedures

• biomarkers of aging including cytokines and anti-inflammatory molecules, previously identified in a focus group of experts

Results and findings will help support changes in clinical practice and decision making, with the aim of reducing adverse outcomes, the worsening of health conditions in the elderly population, the use of healthcare services and, as a consequence, lower healthcare expenditure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of COVID-19

Exclusion Criteria:

• no informed consent

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
Italy	IRCCS INRCA Hospital	Ancona
Italy	IRCCS INRCA Hospital	Casatenovo
Italy	IRCCS INRCA Hospital	Fermo

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Nazionale di Ricovero e Cura per Anziani

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Descriptive-epidemiological analysis of health conditions	Collection of a set of data and indicators of the health conditions including personal data, clinical care, biological and diagnostic data, treatments/procedures and drug therapy	Patients will be followed for the duration of hospital stay, an expected average of 20 days
Secondary	Evaluation of frailty condition	Clinical Frailty Scale (CFS). The CFS divides patients into 9 classes from very fit (CFS=1) to terminally ill (CFS=9)	At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge
Secondary	Identification of biomarkers of inflammation	Analysis for IL6, IL-10, IL-2, IL-7, Alpha 1 Antitrypsin, IP10, MCP1, MIP1 alpha, TNF alpha, IFN alfa, IFN beta	At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge
Secondary	Assessment of functional capacity	Activity of Daily Living (ADL). A summary score ranges from 0 (low function, dependent) to 6 (high function, independent)	At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge
Secondary	Assessment of functional capacity	Activity of Instrumental of Daily Living (IADL). A summary score ranges from 0 (low function, dependent) to 8 (high function, independent)	At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge
Secondary	Evaluation of drug consumption	Drugs prior to admission, drugs administered during hospital stay, prescribed drugs at discharge	At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge
Secondary	Evaluation of inflamma-miRs	Determination of miR-21, miR-146a, miR-155	At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge

External Links

•   IRCCS INRCA website