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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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COVID-19

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of COVID-19 Exclusion Criteria: no informed consent

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Elderly patients affected by COVID-19<br>The group taken into consideration consists of elderly patients hospitalized with diagnosed COVID-19. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, older people, SARS-CoV-2, frailty, physical function, biomarkers of inflammation