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Completed

NCT Number: NCT04390516

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

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

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Coronavirus Infections Infections Lung Diseases Mechanical Ventilation Mortality Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dascena

Oakland, California, 94612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients aged less than 18 years

Treatment and study plan

COViage

Device

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

Primary outcomes

  1. Mechanically ventilated patient outcome

    Time frame: Through study completion, an average of 2 months

    Ventilated or not ventilated within 24 hours

Secondary outcomes

  1. Mortality or mechanically ventilated patient outcome

    Time frame: Through study completion, an average of 2 months

    Death or ventilated, or no death or not ventilated within 24 hours

Sponsors and collaborators

Lead sponsor

Dascena

Industry

Registry information

Official study title

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

Acronym: READY

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 15, 2020
Registry last updated
Jun 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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