NCT04390516

Brief Summary

The purpose of this study is to prospectively evaluate a machine learning algorithm for the prediction of outcomes in COVID-19 patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
197

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable covid19

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

March 24, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

June 12, 2020

Status Verified

June 1, 2020

Enrollment Period

1 month

First QC Date

May 14, 2020

Last Update Submit

June 10, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mechanically ventilated patient outcome

    Ventilated or not ventilated within 24 hours

    Through study completion, an average of 2 months

Secondary Outcomes (1)

  • Mortality or mechanically ventilated patient outcome

    Through study completion, an average of 2 months

Study Arms (1)

COViage

OTHER

Machine learning intervention

Device: COViage

Interventions

COViageDEVICE

The COViage machine learning algorithm is designed to predict mechanical ventilation and mortality within 24 hours after hospital admission.

COViage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 years or older
  • Confirmed COVID-19 infection through RT-PCR test

You may not qualify if:

  • Patients aged less than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dascena

Oakland, California, 94612, United States

Location

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2020

First Posted

May 15, 2020

Study Start

March 24, 2020

Primary Completion

May 4, 2020

Study Completion

May 30, 2020

Last Updated

June 12, 2020

Record last verified: 2020-06

Locations