Respiratory Decompensation and Model for the Triage of CO... | NCT04390516

Studies
Respiratory Decompensation and Model for the Triage of COVID-19 Patients

NCT04390516

Sponsor

Dascena

Status

Completed

Last Update Posted

Jun 12, 2020Actual

Enrollment

197Actual

Phase

Not Applicable

Conditions

COVID-19
Coronavirus
Mortality
Mechanical Ventilation

Interventions

COViage

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 24, 2020Actual

Primary Completion Date

May 4, 2020Actual

Completion Date

May 30, 2020Actual

First Submitted Date

May 14, 2020

First Submission Date that Met QC Criteria

May 14, 2020

First Posted Date

May 15, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2020

Last Update Posted Date

Jun 12, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

In a multi-center prospective clinical trial, a machine learning algorithm was deployed at five partner hospitals to analyze live patient data, including blood pressure and Creatinine levels, to determine the algorithm's ability to predict COVID-19 patient prognosis. The primary endpoint was mechanical ventilation of study subjects within 24 hours after hospital admission separate from a decompensation alert related to oxygen levels.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

197Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COViage	Other	Machine learning intervention	Device: COViage

Interventions

Name	Type	Description	Arm Group Labels	Other Names
COViage	Device	The COViage machine learning algorithm is designed to predict mechanical ventilation and mortality within 24 hours after hospital admission.	COViage

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mechanically ventilated patient outcome	Ventilated or not ventilated within 24 hours	Through study completion, an average of 2 months

Secondary Outcomes

Measure	Description	Time Frame
Mortality or mechanically ventilated patient outcome	Death or ventilated, or no death or not ventilated within 24 hours	Through study completion, an average of 2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients aged less than 18 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dascena		Oakland	California	94612	United States

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D018352	Coronavirus Infections

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided