NCT05722665

Brief Summary

This study aims to design a Convolutional Neural Network (CNN) and apply an attention model to help differentiate pneumonia due to Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), pneumonia due to other viruses/bacteria, and normal chest x-ray (CXR) in clinical practice. A bank of digital chest images from a high-complexity health facility in Cali, Colombia, was used.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,599

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 26, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

1.3 years

First QC Date

February 8, 2023

Last Update Submit

February 20, 2023

Conditions

COVID-19 (Coronavirus Disease 2019)COVID-19 Pneumonia

Keywords

COVID-19 (coronavirus disease 2019)Diagnostic ImagingRadiographyThoraxComputer Neural NetworkDeep Learning

Outcome Measures

Primary Outcomes (1)

  • COVID-19 (coronavirus disease 2019) pneumonia chest radiograph identified

    Development and determination of the predictive capacity of a Convolutional Neural Network model to detect viral pneumonia in chest radiographs of adult patients with acute respiratory disease secondary to SARS-COV-2 infection.

    month 8

Study Arms (3)

Normal chest radiographs

X-rays without alterations in the lung parenchyma

Other: Categorization of chest xrays images

COVID-19 chest radiographs

X-rays belonging to patients with a diagnosis of COVID-19 confirmed by positive Reverse Transcriptase polymerase chain reaction (RT-PCR) and/or presence of antibodies to COVID-19 and/or positive COVID-19 viral antigen.

Other: Categorization of chest xrays images

Other pneumonia chest radiographs

X-rays belonging to patients with a diagnosis of pneumonia other than COVID-19

Other: Categorization of chest xrays images

Interventions

Categorization of chest xrays imagesOTHER

Use of Convolutional Neural Network Model to categorize chest xrays images in each group.

COVID-19 chest radiographsNormal chest radiographsOther pneumonia chest radiographs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Group 1: X-rays without alterations in the lung parenchyma Group 2: X-rays belonging to patients with a diagnosis of pneumonia other than COVID-19 Group 3: X-rays belonging to patients with a diagnosis of COVID-19 confirmed by positive Reverse Transcriptase polymerase chain reaction (RT-PCR) and/or presence of antibodies to COVID-19 and/or positive COVID-19 viral antigen.

You may qualify if:

  • Chest radiographs from patients without COVID-19 or other pneumonia took before the pandemic start date (January 2020)
  • Chest radiographs from patients with COVID-19 confirmed by positive Reverse Transcriptase polymerase chain reaction (RT-PCR) and/or presence of antibodies to COVID-19 and/or positive COVID-19 viral antigen.
  • Chest radiographs from patients without COVID-19 confirmed by a negative Reverse Transcriptase polymerase chain reaction (RT-PCR) and other pneumonia diagnoses taken before the pandemic start date (January 2020)

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundacion Valle del Lili

Cali, Valle del Cauca Department, 760001, Colombia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Liliana Fernandez, M.D

    Fundacion Clinica Valle del Lili

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2023

First Posted

February 10, 2023

Study Start

August 26, 2021

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

February 23, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CO(1)