COVID-19NCT04358510
COVID-19 Mortality Prediction Model
An observational study of COVID-19 and Pneumonia, run by Dascena at 1 site in United States.
Trial summary
The objective of this study is to develop and evaluate an algorithm which accurately predicts mortality in COVID-19, pneumonia and mechanically ventilated ICU patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Pneumonia, Mechanical Ventilation
- What is being tested?
- COViage
- Type of treatment
- Medical device
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2020to 17 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Retrospective study of 53,001 total ICU patients, including 9,166 patients with pneumonia and 25,895 mechanically ventilated patients, performed on the MIMIC dataset. The community hospital patient dataset included 114 patients positive for SARS-COV-2 by PCR test.
Who may be able to join
- Patients aged 18 years or older
- Record of ICU stay
Who cannot join
- Patients aged less than 18 years
- Patients for which there were no records of raw data or no discharge or death dates.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mortality Prediction Model for the Triage of COVID-19, Pneumonia and Mechanically Ventilated ICU Patients
The objective of this study is to develop and evaluate an algorithm which accurately predicts mortality in COVID-19, pneumonia and mechanically ventilated ICU patients.
Read the detailed description
Retrospective study of 53,001 total ICU patients, including 9,166 patients with pneumonia and 25,895 mechanically ventilated patients, performed on the MIMIC dataset. The NPH patient dataset includes 114 patients positive for SARS-COV-2 by PCR test.
- Conditions
- COVID-19, Pneumonia, Mechanical Ventilation
- Being tested
- COViage
- Keywords
- machine learning, COVID-19, mortality, prediction, pneumonia, mechanical ventilation
- Medical subject headings
- COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COViageDevice
The COViage machine learning algorithm is designed to predict mortality in COVID-19, pneumonia and mechanically ventilated ICU patients.
| Study group | Role | What they receive |
|---|---|---|
| COViage | Machine learning intervention Receives: Device: COViage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality outcome in COVID-19 ICU patients
Deceased or not deceased
Measured: Through study completion, an average of 2 months
Mortality outcome in mechanically ventilated ICU patients
Deceased or not deceased
Measured: Through study completion, an average of 2 months
Mortality outcome in pneumonia ICU patients
Deceased or not deceased
Measured: Through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Apr 2020
- Primary completion17 Apr 2020
- Study completion17 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dascena
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358510
- Sponsor's protocol ID
- 04202001
- Status last verified
- Apr 2020
- First submitted
- 20 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mortality Prediction Model for the Triage of COVID-19, Pneumonia and Mechanically Ventilated ICU Patients
- ClinicalTrials.gov ID
- NCT04358510
- Acronym / sponsor ID
- 04202001
- Conditions
- COVID-19, Pneumonia, Mechanical Ventilation
- Keywords
- machine learning, COVID-19, mortality, prediction, pneumonia, mechanical ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- DascenaIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 17 Apr 2020 (actual)
- Study completion
- 17 Apr 2020 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to develop and evaluate an algorithm which accurately predicts mortality in COVID-19, pneumonia and mechanically ventilated ICU patients.
Detailed description
Retrospective study of 53,001 total ICU patients, including 9,166 patients with pneumonia and 25,895 mechanically ventilated patients, performed on the MIMIC dataset. The NPH patient dataset includes 114 patients positive for SARS-COV-2 by PCR test.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COViage | – | Device: COViageMachine learning intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective study of 53,001 total ICU patients, including 9,166 patients with pneumonia and 25,895 mechanically ventilated patients, performed on the MIMIC dataset. The community hospital patient dataset included 114 patients positive for SARS-COV-2 by PCR test.
Key inclusion criteria (2 listed)
- Patients aged 18 years or older
- Record of ICU stay
Key exclusion criteria (2 listed)
- Patients aged less than 18 years
- Patients for which there were no records of raw data or no discharge or death dates.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COViageThe COViage machine learning algorithm is designed to predict mortality in COVID-19, pneumonia and mechanically ventilated ICU patients. | Device | COViage |
Primary outcome
Mortality outcome in COVID-19 ICU patients
Time frame: Through study completion, an average of 2 months
Deceased or not deceased
Mortality outcome in mechanically ventilated ICU patients
Time frame: Through study completion, an average of 2 months
Deceased or not deceased
Mortality outcome in pneumonia ICU patients
Time frame: Through study completion, an average of 2 months
Deceased or not deceased
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Pneumonia, run by Dascena at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality outcome in COVID-19 ICU patients (time frame: Through study completion, an average of 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.