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

October 19, 2023 updated by: Istituto Nazionale di Ricovero e Cura per Anziani

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Ancona, Italy, 60129
        • Recruiting
        • IRCCS INRCA Hospital
        • Contact:
        • Principal Investigator:
          • Antonio Cherubini, MD
      • Casatenovo, Italy
        • Recruiting
        • IRCCS INRCA Hospital
        • Contact:
        • Principal Investigator:
          • Daniele Colombo, MD
      • Fermo, Italy
        • Recruiting
        • IRCCS INRCA Hospital
        • Contact:
        • Principal Investigator:
          • Demetrio Postacchini, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Elderly patients 65 years old and above hospitalized for COVID-19

Description

Inclusion Criteria:

  • diagnosis of COVID-19

Exclusion Criteria:

  • no informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Elderly patients affected by COVID-19
The group taken into consideration consists of elderly patients hospitalized with diagnosed COVID-19.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Descriptive-epidemiological analysis of health conditions
Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 20 days
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
Time Frame: At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge
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
Time Frame: At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge
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
Time Frame: At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge
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
Time Frame: At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge
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
Time Frame: At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge
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
Time Frame: At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Nazionale di Ricovero e Cura per Anziani

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2020

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

April 10, 2020

First Submitted That Met QC Criteria

April 14, 2020

First Posted (Actual)

April 16, 2020

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INRCA_01_2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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