NCT06424925

Brief Summary

Predictive models can be applied in different areas, during the emergency of the COVID-19 pandemic, in fact, they have proven important in supporting health systems in planning strategic decisions and in formulating health policies for the containment of the disease. The Covid-19 pandemic, in particular, has represented a real challenge for our healthcare system. In Italy, it was divided into four main waves, each characterized by different types of patients and different therapeutic approaches progressively improved based on new scientific evidence. The objective is to carry out a study on the data of patients hospitalized for COVID-19 at the ASST of Lecco during all four pandemic waves, with different degrees of severity of illness, collecting the data of interest and applying it to they use artificial intelligence to identify recurring patterns of clinical outcome in terms of survival and secondary infectious complications, so as to build new reliable predictive statistical models that can be used to predict the outcome of the patients themselves. The strong ambition of this project is that the application of artificial intelligence to data of such significant quantity can allow us to build valid statistical models which can then be hypothetically applied to any patient to predict, based on anamnestic characteristics, blood chemical parameters. at baseline and at the set treatment, the probability of survival and complications

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
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

May 21, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 23, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

May 21, 2024

Last Update Submit

May 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Construction of predictive models

    Construction of predictive models to evaluate clinical outcomes such as death and/or onset of secondary infection based on the data collected relating to the 4 COVID-19 waves.

    6 months

Study Arms (4)

COVID-19 1° wave

Hospitalized patients for COVID19 pneumonia during first wave (FEB-MAY 2020)

Other: Artificial intelligence for the prediction of clinical outcomes

COVID-19 2° wave

Hospitalized patients for COVID19 pneumonia during the second wave (OCT-DEC 2020)

Other: Artificial intelligence for the prediction of clinical outcomes

COVID-19 3° wave

Hospitalized patients for COVID19 pneumonia during the third wave (GEN-MAY 2021)

Other: Artificial intelligence for the prediction of clinical outcomes

COVID-19 4° wave

Hospitalized patients for COVID19 pneumonia during the fourth wave (NOV 2021-MAR 2022)

Other: Artificial intelligence for the prediction of clinical outcomes

Interventions

Use of artificial intelligence (AI) for the prediction of clinical outcomes such as death and complications in patients hospitalized for COVID pneumonia during the 4 pandemic waves

COVID-19 1° waveCOVID-19 2° waveCOVID-19 3° waveCOVID-19 4° wave

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

For each patient, information will be collected regarding: * Personal data (i.e. age, sex, nationality); * Date of hospitalization and discharge (or death) * Comorbidities; * Treatments undertaken for Covid19; * Possible vaccination for Covid19, date and number of doses; * Possible onset of secondary infections and/or complications; * Blood chemistry tests upon admission

You may qualify if:

  • Age \> 18 years;
  • Hospitalization for COVID-19 pneumonia at ASST Lecco.

You may not qualify if:

  • Hospitalization or finding of asymptomatic SARS CoV-2 infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stefania Piconi

Lecco, 23900, Italy

Location

MeSH Terms

Conditions

COVID-19

Interventions

Artificial Intelligence

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AlgorithmsMathematical Concepts

Central Study Contacts

Stefania Piconi, MD

CONTACT

Silvia Pontiggia, MS

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Infectious Diseases Unit

Study Record Dates

First Submitted

May 21, 2024

First Posted

May 22, 2024

Study Start

June 1, 2024

Primary Completion

September 1, 2024

Study Completion

December 31, 2024

Last Updated

May 23, 2024

Record last verified: 2024-05

Locations