Covid19NCT04825301
Application of Machine Learning Based Approaches in Emergency Department to Support Clinical Decision Managing SARS-CoV-2 Infected Patients
An observational study of Covid19, run by University of L'Aquila at 1 site in Italy.
Trial summary
The aim of the study is to develop a prognostic prediction model based on machine learning algorithms in patients affected by coronavirus disease 2019 (COVID-19), the prediction model will be capable to recognize patient with favorable prognosis or patient with poor prognosis by intelligent systems data analysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- How many people
- 779 participants
- Where
- 1 siteItaly
- Study dates
- 27 Feb 2020to 30 Apr 2022
- 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: Italian caucasian patients aged over 18 years old SARS-CoV-2 infection confirmed by PCR
Who may be able to join
- patients aged over 18 positive for COVID-19 by polymerase chain reaction assay for rhino-pharyngeal swab
Who cannot join
- Under 18 aged
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of L'Aquila
L’Aquila, 67100
Clara Balsano, +39 0862434774, clara.balsano@univaq.it
About this study
The aim of the study is to develop a prognostic prediction model based on machine learning algorithms in patients affected by coronavirus disease 2019 (COVID-19), the prediction model will be capable to recognize patient with favorable prognosis or patient with poor prognosis by intelligent systems data analysis.
- Conditions
- Covid19
- Keywords
- Covid19, machine learning, prediction model, convolutional neural network
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| training cohort | data collection | |
| validation cohort | data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 clinical course
Data about sex, age, symptoms start date, symptoms, comorbidity, vital parameters, hematochemical blood tests, therapy, oxygen support, radiology, clinical disease progression will be collected. The collected data will be analyzed through a machine learning based approach to predict the prognosis of patients affected by COVID-19.
Measured: 2 months
Secondary outcomes (1)
Application of machine learning algorithms on data of patients affected by COVID-19
The collected data will be analyzed through a machine learning based approach to establish correlations between collected data and the prognosis of patients affected by COVID-19.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start27 Feb 2020
- Primary completion30 Mar 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- 779 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of L'Aquila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clara Balsano, University of L'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825301
- Sponsor's protocol ID
- prot. N. 28958
- Status last verified
- Sep 2021
- First submitted
- 29 Mar 2021
- Last updated
- 24 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Machine Learning Based Approaches in Emergency Department to Support Clinical Decision Managing SARS-CoV-2 Infected Patients
- ClinicalTrials.gov ID
- NCT04825301
- Acronym / sponsor ID
- prot. N. 28958
- Conditions
- Covid19
- Keywords
- Covid19, machine learning, prediction model, convolutional neural network
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 779 participants (estimated)
- Lead sponsor
- University of L'AquilaUniversity, hospital or other
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 1 Apr 2021 (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 aim of the study is to develop a prognostic prediction model based on machine learning algorithms in patients affected by coronavirus disease 2019 (COVID-19), the prediction model will be capable to recognize patient with favorable prognosis or patient with poor prognosis by intelligent systems data analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| training cohort | – | –data collection |
| validation cohort | – | –data collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Italian caucasian patients aged over 18 years old SARS-CoV-2 infection confirmed by PCR
Key inclusion criteria (1 listed)
- patients aged over 18 positive for COVID-19 by polymerase chain reaction assay for rhino-pharyngeal swab
Key exclusion criteria (1 listed)
- Under 18 aged
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
COVID-19 clinical course
Time frame: 2 months
Data about sex, age, symptoms start date, symptoms, comorbidity, vital parameters, hematochemical blood tests, therapy, oxygen support, radiology, clinical disease progression will be collected. The collected data will be analyzed through a machine learning based approach to predict the prognosis of patients affected by COVID-19.
1 secondary outcome
Application of machine learning algorithms on data of patients affected by COVID-19
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
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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.
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 Covid19, run by University of L'Aquila at 1 site in Italy.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Feb 2022. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 clinical course (time frame: 2 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 24 Feb 2022.