Use of Artificial Intelligence (AI) to Predict Clinical Outcomes in Patients Hospitalized for COVID19 Pneumonia During the 4 Pandemic Waves (AI COVID-19)

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 at the ASST of Lecco.

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

Study Overview

• Status: Not yet recruiting
• Conditions: COVID-19 Pandemic
• Intervention / Treatment: Other: Artificial intelligence for the prediction of clinical outcomes

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Stefania Piconi, MD; Phone Number: +390341489890; Email: s.piconi@asst-lecco.it
• Study Contact Backup: Name: Silvia Pontiggia, MS; Phone Number: +390341253678; Email: s.pontiggia@asst-lecco.it

Study Locations

• Italy
  • Lecco, Italy, 23900
    • Stefania Piconi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID-19 1° wave; Hospitalized patients for COVID19 pneumonia during first wave (FEB-MAY 2020)	Other: Artificial intelligence for the prediction of clinical outcomes; 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 2° wave; Hospitalized patients for COVID19 pneumonia during the second wave (OCT-DEC 2020)	Other: Artificial intelligence for the prediction of clinical outcomes; 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 3° wave; Hospitalized patients for COVID19 pneumonia during the third wave (GEN-MAY 2021)	Other: Artificial intelligence for the prediction of clinical outcomes; 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 4° wave; Hospitalized patients for COVID19 pneumonia during the fourth wave (NOV 2021-MAR 2022)	Other: Artificial intelligence for the prediction of clinical outcomes; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera di Lecco

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: May 21, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 23, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; COVID-19; Pneumonia
• Other Study ID Numbers: AI COVID-19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No