Identification of a Responsive Subpopulation to Hydroxych... | NCT04423991

Studies
Identification of a Responsive Subpopulation to Hydroxychloroquine in COVID-19 Patients Using Machine Learning

NCT04423991

Sponsor

Dascena

Status

Completed

Last Update Posted

Jun 9, 2020Actual

Enrollment

290Actual

Phase

Not Applicable

Conditions

COVID-19
Coronavirus
Mortality

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 10, 2020Actual

Primary Completion Date

Jun 4, 2020Actual

Completion Date

Jun 4, 2020Actual

First Submitted Date

Jun 8, 2020

First Submission Date that Met QC Criteria

Jun 8, 2020

First Posted Date

Jun 9, 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 8, 2020

Last Update Posted Date

Jun 9, 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 was to assess the performance of a machine learning algorithm which identifies patients for whom hydroxychloroquine treatment is associated with predicted survival.

Detailed Description

In a multi-center pragmatic clinical trial, COVID-19 positive patients admitted to 6 United States medical centers were enrolled between March 10 and June 4, 2020. A machine learning algorithm was used to determine which patients were suitable for treatment with hydroxychloroquine.

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

290Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exposed group	Experimental	All patients were exposed to the algorithm and were characterized as being likely responders to hydroxychloroquine treatment. Treatment decisions regarding the administration of hydroxychloroquine were made independently by care providers.	Device: COViage

Interventions

Name	Type	Description	Arm Group Labels	Other Names
COViage	Device	Machine learning intervention	Exposed group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality outcome	Time to in-hospital death	Through study completion, an average of 3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient admitted to covered ward and tested positive for COVID-19
Patient had COViage applied to electronic health record data within four hours of COVID-19 test

Exclusion Criteria:

Patient not admitted to covered ward or tested negative for COVID-19
Patient had COViage applied to electronic health record data greater than four hours after COVID-19 test

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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