COVID-19IDENTIFYNCT04423991
Identification of a Responsive Subpopulation to Hydroxychloroquine in COVID-19 Patients Using Machine Learning
A study testing COViage in people with COVID-19 and Coronavirus, run by Dascena at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19, Coronavirus, Mortality
- What is being tested?
- COViage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2020to 4 Jun 2020
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of a Responsive Subpopulation to Hydroxychloroquine in COVID-19 Patients Using Machine Learning: the IDENTIFY Trial
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.
Read the detailed description
In a multi-center pragmatic clinical trial, COVID-19 positive patients admitted to 6 United States medical centers were enrolled between March 10 and June 4, 2020. A machine learning algorithm was used to determine which patients were suitable for treatment with hydroxychloroquine.
- Conditions
- COVID-19, Coronavirus, Mortality
- Being tested
- COViage
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COViageDevice
Machine learning intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: COViage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality outcome
Time to in-hospital death
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start10 Mar 2020
- Primary completion4 Jun 2020
- Study completion4 Jun 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dascena
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423991
- Sponsor's protocol ID
- 060820
- Acronym
- IDENTIFY
- Status last verified
- Jun 2020
- First submitted
- 8 Jun 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of a Responsive Subpopulation to Hydroxychloroquine in COVID-19 Patients Using Machine Learning: the IDENTIFY Trial
- ClinicalTrials.gov ID
- NCT04423991
- Acronym / sponsor ID
- IDENTIFY / 060820
- Conditions
- COVID-19, Coronavirus, Mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- DascenaIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 4 Jun 2020 (actual)
- Study completion
- 4 Jun 2020 (actual)
- First posted
- 9 Jun 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 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.
Detailed description
In a multi-center pragmatic clinical trial, COVID-19 positive patients admitted to 6 United States medical centers were enrolled between March 10 and June 4, 2020. A machine learning algorithm was used to determine which patients were suitable for treatment with hydroxychloroquine.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exposed group | Experimental | Device: COViageAll 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| COViageMachine learning intervention | Device | Exposed group |
Primary outcome
Mortality outcome
Time frame: Through study completion, an average of 3 months
Time to in-hospital death
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 9 Jun 2020.
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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?
A study testing COViage in people with COVID-19 and Coronavirus, 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 9 Jun 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 (time frame: Through study completion, an average of 3 months). 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 9 Jun 2020.