Back to resultsRespiratory Decompensation and Model for the Triage of COVID-19 Patients (READY)
Primary Purpose
COVID-19, Coronavirus, Mortality
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COViage
Sponsored by
About this trial
This is an interventional diagnostic trial for COVID-19
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
Sites / Locations
- Dascena
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
COViage
Arm Description
Machine learning intervention
Outcomes
Primary Outcome Measures
Mechanically ventilated patient outcome
Ventilated or not ventilated within 24 hours
Secondary Outcome Measures
Mortality or mechanically ventilated patient outcome
Death or ventilated, or no death or not ventilated within 24 hours
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04390516
Brief Title
Respiratory Decompensation and Model for the Triage of COVID-19 Patients
Acronym
READY
Official Title
Prediction Of Respiratory Decompensation In Covid-19 Patients Using Machine Learning: The READY Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 24, 2020 (Actual)
Primary Completion Date
May 4, 2020 (Actual)
Study Completion Date
May 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dascena
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Coronavirus, Mortality, Mechanical Ventilation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
197 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COViage
Arm Type
Other
Arm Description
Machine learning intervention
Intervention Type
Device
Intervention Name(s)
COViage
Intervention Description
The COViage machine learning algorithm is designed to predict mechanical ventilation and mortality within 24 hours after hospital admission.
Primary Outcome Measure Information:
Title
Mechanically ventilated patient outcome
Description
Ventilated or not ventilated within 24 hours
Time Frame
Through study completion, an average of 2 months
Secondary Outcome Measure Information:
Title
Mortality or mechanically ventilated patient outcome
Description
Death or ventilated, or no death or not ventilated within 24 hours
Time Frame
Through study completion, an average of 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Dascena
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Respiratory Decompensation and Model for the Triage of COVID-19 Patients
We'll reach out to this number within 24 hrs