NCT04423991

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
290

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 10, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

3 months

First QC Date

June 8, 2020

Last Update Submit

June 8, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mortality outcome

    Time to in-hospital death

    Through study completion, an average of 3 months

Study Arms (1)

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

COViageDEVICE

Machine learning intervention

Exposed group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

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
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2020

First Posted

June 9, 2020

Study Start

March 10, 2020

Primary Completion

June 4, 2020

Study Completion

June 4, 2020

Last Updated

June 9, 2020

Record last verified: 2020-06

Locations