Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04348396
Recruitment Status : Recruiting
First Posted : April 16, 2020
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
Istituto Nazionale di Ricovero e Cura per Anziani

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.


Condition or disease
COVID-19

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: ReportAge-COVID Project: Clinical and Biological Predictors of COVID-19 Disease in Older Patients
Actual Study Start Date : April 3, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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)

  4. 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)

  5. 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

  6. 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


Biospecimen Retention:   Samples Without DNA
The surplus of serum and plasma in the blood samples taken from patients for routine examinations during hospitalization will be stored at -80°C at the BioGer biobank of IRCCS INRCA.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Elderly patients 65 years old and above hospitalized for COVID-19
Criteria

Inclusion Criteria:

  • diagnosis of COVID-19

Exclusion Criteria:

  • no informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04348396


Contacts
Layout table for location contacts
Contact: Silvia Bustacchini, MD 00390718004613 s.bustacchini@inrca.it

Locations
Layout table for location information
Italy
IRCCS INRCA Hospital Recruiting
Ancona, Italy, 60129
Contact: Antonio Cherubini, MD    00390718003537    a.cherubini@inrca.it   
Principal Investigator: Antonio Cherubini, MD         
IRCCS INRCA Hospital Recruiting
Casatenovo, Italy
Contact: Daniele Colombo, MD       d.colombo@inrca.it   
Principal Investigator: Daniele Colombo, MD         
IRCCS INRCA Hospital Recruiting
Fermo, Italy
Contact: Cinzia Giuli       c.giuli@inrca.it   
Principal Investigator: Demetrio Postacchini, MD         
Sponsors and Collaborators
Istituto Nazionale di Ricovero e Cura per Anziani
Additional Information:
Layout table for additonal information
Responsible Party: Istituto Nazionale di Ricovero e Cura per Anziani
ClinicalTrials.gov Identifier: NCT04348396    
Other Study ID Numbers: INRCA_01_2020
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istituto Nazionale di Ricovero e Cura per Anziani:
COVID-19
older people
SARS-CoV-2
frailty
physical function
biomarkers of inflammation