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

NCT ID: NCT04348396

Last Updated: 2023-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-03

Study Completion Date

2024-04-30

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.

Conditions

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COVID-19

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Elderly patients affected by COVID-19

The group taken into consideration consists of elderly patients hospitalized with diagnosed COVID-19.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* diagnosis of COVID-19

Exclusion Criteria

* no informed consent
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Nazionale di Ricovero e Cura per Anziani

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS INRCA Hospital

Ancona, , Italy

Site Status RECRUITING

IRCCS INRCA Hospital

Casatenovo, , Italy

Site Status RECRUITING

IRCCS INRCA Hospital

Fermo, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Anna Rita Bonfigli, PhD

Role: CONTACT

00390718003719

Facility Contacts

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Antonio Cherubini, MD

Role: primary

00390718003537

Daniele Colombo, MD

Role: primary

Cinzia Giuli

Role: primary

Related Links

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http://www.inrca.it

IRCCS INRCA website

Other Identifiers

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INRCA_01_2020

Identifier Type: -

Identifier Source: org_study_id

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