NCT04358536

Brief Summary

The objective of this study is to assess three configurations of two convolutional deep neural network architectures for the classification of COVID-19 PCX images.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

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

April 1, 2020

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

16 days

First QC Date

April 20, 2020

Last Update Submit

April 21, 2020

Conditions

COVID-19

Keywords

machine learningX-rayclassificationCOVID-19posteroanteriorconvolutional neural network architectures

Outcome Measures

Primary Outcomes (1)

  • Identification of COVID-19

    Identification of COVID-19 infection from chest X-ray analysis

    Through study completion, an average of 2 months

Study Arms (2)

COVID-19 Patients

Single posteroanterior (or "front-on") X-rays collected from COVID-19 patients

Device: CovX

Non COVID-19 Patients

Single posteroanterior (or "front-on") X-rays collected from subsets of non COVID-19 patients

Device: CovX

Interventions

CovXDEVICE

Convolutional neural network for classification of COVID-19 from chest X-rays

COVID-19 PatientsNon COVID-19 Patients

Eligibility Criteria

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

115 COVID-19 single PCX images and 115 non COVID-19 single PCX images (230 images total), collected from 81 unique COVID-19 patients and 91 unique non COVID-19 patients.

You may qualify if:

  • Single PCX images collected from patients over 18 years of age

You may not qualify if:

  • CT scans composed of multiple concerted X-rays
  • Single PCX images collected from patients under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dascena

Oakland, California, 94612-2603, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

April 20, 2020

First Posted

April 24, 2020

Study Start

April 1, 2020

Primary Completion

April 17, 2020

Study Completion

April 17, 2020

Last Updated

April 24, 2020

Record last verified: 2020-04

Locations

US(1)