NCT04348396

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

4.1 years

First QC Date

April 10, 2020

Last Update Submit

October 19, 2023

Conditions

Keywords

COVID-19older peopleSARS-CoV-2frailtyphysical functionbiomarkers of inflammation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Evaluation of frailty condition

    At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge

  • Identification of biomarkers of inflammation

    At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge

  • Assessment of functional capacity

    At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge

  • Assessment of functional capacity

    At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge

  • Evaluation of drug consumption

    At admission, at discharge, an expected average of 6 weeks and at 1, 3, 6, 12 months after discharge

  • +1 more secondary outcomes

Study Arms (1)

Elderly patients affected by COVID-19

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

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • diagnosis of COVID-19

You may not qualify if:

  • no informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

IRCCS INRCA Hospital

Ancona, 60129, Italy

RECRUITING

IRCCS INRCA Hospital

Casatenovo, Italy

RECRUITING

IRCCS INRCA Hospital

Fermo, Italy

RECRUITING

Related Links

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.

MeSH Terms

Conditions

COVID-19Frailty

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Anna Rita Bonfigli, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2020

First Posted

April 16, 2020

Study Start

April 3, 2020

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations