Clinical trial NCT04834934: Artificial Intelligence - SARS-CoV-2 (COVID-19) Risk Evaluation
Official title: Artificial Intelligence - SARS-CoV-2 Risk Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: Artificial Intelligence
Covid19
Chest CT
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
Collaborators: name: Regione Lombardia
name: Orobix Srl
name: Microsoft Corporation
name: ASST Bergamo Est
name: Centro Cardiologico Monzino
name: NVIDIA Corporation
name: PORINI Srl
First posted: 2021-04-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Training, testing and validation of an AI platform for predicting Italian first wave Covid-19 patients prognosis.
timeFrame: 9 months
Secondary outcomes:
measure: Validation of the developed AI platform on italian second wave of Covid-19 patients
timeFrame: 3 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS San Raffaele
Study officials:
affiliation: IRCCS San Raffaele
name: Antonio Esposito, MD
role: PRINCIPAL_INVESTIGATOR
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