Evaluation of a COVID-19 Pneumonia CXR AI Detection Algorithm

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2020-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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RT-PCR Positive Patients

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

AI model

Intervention Type DIAGNOSTIC_TEST

Deep Learning CNN model

Negative patients

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

AI model

Intervention Type DIAGNOSTIC_TEST

Deep Learning CNN model

Interventions

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AI model

Deep Learning CNN model

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes