Clinical trial NCT04348396: Clinical and Biological Predictors of COVID-19 Disease in Older Patients
Official title: ReportAge-COVID Project: Clinical and Biological Predictors of COVID-19 Disease in Older Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Keywords: COVID-19
older people
SARS-CoV-2
frailty
physical function
biomarkers of inflammation
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elderly patients 65 years old and above hospitalized for COVID-19

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* diagnosis of COVID-19

Exclusion Criteria:

* no informed consent

Primary outcomes:
measure: Descriptive-epidemiological analysis of health conditions
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 20 days
Secondary outcomes:
measure: Evaluation of frailty condition
timeFrame: At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge
measure: Identification of biomarkers of inflammation
timeFrame: At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge
measure: Assessment of functional capacity
timeFrame: At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge
measure: Assessment of functional capacity
timeFrame: At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge
measure: Evaluation of drug consumption
timeFrame: At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge
measure: Evaluation of inflamma-miRs
timeFrame: At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: IRCCS INRCA Hospital
city: Casatenovo
country: Italy
facility: IRCCS INRCA Hospital
city: Fermo
country: Italy
facility: IRCCS INRCA Hospital
Study officials:
References: