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

COVID-19 Clinical Trial

— READY  

Official title:

Prediction Of Respiratory Decompensation In Covid-19 Patients Using Machine Learning: The READY Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04390516
• Other study ID #: 051420
• Status: Completed
• Phase: N/A
• Start date: March 24, 2020
• Est. completion date: May 30, 2020

Study information

• Verified date: June 2020
• Source: Dascena
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: May 30, 2020
• Est. primary completion date: May 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged 18 years or older

• Confirmed COVID-19 infection through RT-PCR test

Exclusion Criteria:

• Patients aged less than 18 years

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections
• COVID-19
• Mechanical Ventilation
• Mortality

Intervention

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

Locations

Country	Name	City	State
United States	Dascena	Oakland	California

Sponsors (1)

Lead Sponsor	Collaborator
Dascena

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mechanically ventilated patient outcome	Ventilated or not ventilated within 24 hours	Through study completion, an average of 2 months
Secondary	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