Artificial Intelligence - SARS-CoV-2 (COVID-19) Risk Evaluation (AI-SCoRE)

April 29, 2025 updated by: Antonio Esposito, IRCCS San Raffaele

Artificial Intelligence - SARS-CoV-2 Risk Evaluation

The management of COVID-19 patients in overwhelmed hospital facing the pandemic is a clinical challenge.

The improvement of decision making may allow a better allocation of available resources and a better treatment of patients at higher risk.

Chest CT has been widely adopted for COVID-19 pneumonia diagnosis. Several experiences documented the capability of Artificial Intelligence to improve and fasten COVID-19 pneumonia detection, mainly using chest X-ray.

Aim of the present study was to develop and validate an Artificial Intelligence approach integrating clinical and imaging data (automatically extracted through the adoption of dedicated neural networks) for the creation of a cloud platform capable of performing automatic patients risk stratification. Such an approach could be used for triage of COVID-19 patients in the emergency department, with the aim to improve healthcare personnel decision-making and allocation of resources during health emergencies.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy, 20132
        • IRCCS San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with confirmed SARS-CoV-2 infection with RT-PCR who performed non contrast chest CT scan within 72 hours after admission to the emergency department

Description

Inclusion Criteria:

  • confirmed SARS-CoV-2 infection with RT-PCR
  • non contrast chest CT scan performed within 72 hours after admission to the emergency department

Exclusion Criteria:

  • age < 18 ys

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
COVID-19 first wave patients
1700 patients retrospectively enrolled in 15 Italian hospitals from 16/2/2020 to 29/4/2020.
COVID-19 second wave patients
300 patients prospectively enrolled in IRCCS San Raffaele Hospital from 19/10/2020 to 31/12/2020.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Training, testing and validation of an AI platform for predicting Italian first wave Covid-19 patients prognosis.
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Validation of the developed AI platform on italian second wave of Covid-19 patients
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Collaborators

Centro Cardiologico Monzino
Regione Lombardia
Orobix Srl
Microsoft Corporation
ASST Bergamo Est
NVIDIA Corporation
PORINI Srl

Investigators

  • Principal Investigator: Antonio Esposito, MD, IRCCS San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2020

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

April 6, 2021

First Submitted That Met QC Criteria

April 6, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 29, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI-SCoRE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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