Evaluation of a COVID-19 Pneumonia CXR AI Detection Algorithm

Ensemble Group Holdings

Status: Unknown

Conditions: Covid19

Treatments: Diagnostic Test: AI model

Study type: Observational

Funder types: Industry

Identifiers

NCT04561024

EN-092020

Details and patient eligibility

About

This study investigates the diagnostic performance of an AI algorithm in the detection of COVID-19 pneumonia on chest radiographs.

Full description

This is an international multi-center study. Chest radiographs (CXR) from different participating centers will be collected to develop an AI algorithm to detect COVID-19 pneumonia. This will be tested on external hold out datasets from different centers using SARS-CoV-2 by Real-Time Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) Assay as ground truth.

Enrollment: 4,000 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All adult patients >18 years of age
• Attended any of the participating institutes between February 1, 2020 until September, 2020
• Underwent both RT-PCR testing and frontal CXR (within 48 hours of PCR testing) for COVID-19 infection
• frontal CXR of patients pre-covid pandemic

Exclusion criteria

• Unavailability of patient demographics and clinical data
• Inconclusive RT-PCR results
• CXR considered to be of non-diagnostic quality by the clinical radiology research team at each site
• CXR not in a retrievable or processable format for AI inference

Trial design

4,000 participants in 2 patient groups

RT-PCR Positive Patients

Description:

RT-PCR confirmed patients positive for SARS-CoV-2

Treatment:

Diagnostic Test: AI model

Negative patients

Description:

RT-PCR confirmed patients negative for SARS-CoV-2 or patients with CXR performed before the emergence of COVID-19 pandemic

Treatment:

Diagnostic Test: AI model