COVID-19 PandemicAI COVID-19NCT06424925
Use of Artificial Intelligence (AI) to Predict Clinical Outcomes in Patients Hospitalized for COVID19 Pneumonia During the 4 Pandemic Waves
An observational study of COVID-19 Pandemic, run by Azienda Ospedaliera di Lecco at 1 site in Italy.
Trial summary
Predictive models can be applied in different areas, during the emergency of the COVID-19 pandemic, in fact, they have proven important in supporting health systems in planning strategic decisions and in formulating health policies for the containment of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pandemic
- What is being tested?
- Artificial intelligence for the prediction of clinical outcomes
- How many people
- 5,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2024to 31 Dec 2024
- 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: For each patient, information will be collected regarding: * Personal data (i.e. age, sex, nationality); * Date of hospitalization and discharge (or death) * Comorbidities; * Treatments undertaken for Covid19; * Possible vaccination for Covid19, date and number of doses; * Possible onset of secondary infections and/or complications; * Blood chemistry tests upon admission
Who may be able to join
- Age > 18 years;
- Hospitalization for COVID-19 pneumonia at ASST Lecco.
Who cannot join
- Hospitalization or finding of asymptomatic SARS CoV-2 infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Artificial Intelligence (AI) for the Prediction of Clinical Outcomes Such as Death and Complications in Patients Hospitalized for COVID Pneumonia During the 4 Pandemic Waves at the ASST of Lecco.
Predictive models can be applied in different areas, during the emergency of the COVID-19 pandemic, in fact, they have proven important in supporting health systems in planning strategic decisions and in formulating health policies for the containment of the disease.
The Covid-19 pandemic, in particular, has represented a real challenge for our healthcare system. In Italy, it was divided into four main waves, each characterized by different types of patients and different therapeutic approaches progressively improved based on new scientific evidence.
Read more
The objective is to carry out a study on the data of patients hospitalized for COVID-19 at the ASST of Lecco during all four pandemic waves, with different degrees of severity of illness, collecting the data of interest and applying it to they use artificial intelligence to identify recurring patterns of clinical outcome in terms of survival and secondary infectious complications, so as to build new reliable predictive statistical models that can be used to predict the outcome of the patients themselves.
The strong ambition of this project is that the application of artificial intelligence to data of such significant quantity can allow us to build valid statistical models which can then be hypothetically applied to any patient to predict, based on anamnestic characteristics, blood chemical parameters. at baseline and at the set treatment, the probability of survival and complications
- Conditions
- COVID-19 Pandemic
- Being tested
- Artificial intelligence for the prediction of clinical outcomes
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial intelligence for the prediction of clinical outcomesOther
Use of artificial intelligence (AI) for the prediction of clinical outcomes such as death and complications in patients hospitalized for COVID pneumonia during the 4 pandemic waves
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 1° wave | Hospitalized patients for COVID19 pneumonia during first wave (FEB-MAY 2020) Receives: Other: Artificial intelligence for the prediction of clinical outcomes | |
| COVID-19 2° wave | Hospitalized patients for COVID19 pneumonia during the second wave (OCT-DEC 2020) Receives: Other: Artificial intelligence for the prediction of clinical outcomes | |
| COVID-19 3° wave | Hospitalized patients for COVID19 pneumonia during the third wave (GEN-MAY 2021) Receives: Other: Artificial intelligence for the prediction of clinical outcomes | |
| COVID-19 4° wave | Hospitalized patients for COVID19 pneumonia during the fourth wave (NOV 2021-MAR 2022) Receives: Other: Artificial intelligence for the prediction of clinical outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Construction of predictive models
Construction of predictive models to evaluate clinical outcomes such as death and/or onset of secondary infection based on the data collected relating to the 4 COVID-19 waves.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies 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
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Lecco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefania Piconi, Azienda Ospedaliera di Lecco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424925
- Sponsor's protocol ID
- AI COVID-19
- Acronym
- AI COVID-19
- Status last verified
- May 2024
- First submitted
- 21 May 2024
- Last updated
- 23 May 2024
- 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 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Artificial Intelligence (AI) for the Prediction of Clinical Outcomes Such as Death and Complications in Patients Hospitalized for COVID Pneumonia During the 4 Pandemic Waves at the ASST of Lecco.
- ClinicalTrials.gov ID
- NCT06424925
- Acronym / sponsor ID
- AI COVID-19 / AI COVID-19
- Conditions
- COVID-19 Pandemic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera di LeccoUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 May 2024 (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.
Predictive models can be applied in different areas, during the emergency of the COVID-19 pandemic, in fact, they have proven important in supporting health systems in planning strategic decisions and in formulating health policies for the containment of the disease.
The Covid-19 pandemic, in particular, has represented a real challenge for our healthcare system. In Italy, it was divided into four main waves, each characterized by different types of patients and different therapeutic approaches progressively improved based on new scientific evidence.
The objective is to carry out a study on the data of patients hospitalized for COVID-19 at the ASST of Lecco during all four pandemic waves, with different degrees of severity of illness, collecting the data of interest and applying it to they use artificial intelligence to identify recurring patterns of clinical outcome in terms of survival and secondary infectious complications, so as to build new reliable predictive statistical models that can be used to predict the outcome of the patients themselves.
The strong ambition of this project is that the application of artificial intelligence to data of such significant quantity can allow us to build valid statistical models which can then be hypothetically applied to any patient to predict, based on anamnestic characteristics, blood chemical parameters. at baseline and at the set treatment, the probability of survival and complications
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| COVID-19 1° wave | – | Other: Artificial intelligence for the prediction of clinical outcomesHospitalized patients for COVID19 pneumonia during first wave (FEB-MAY 2020) |
| COVID-19 2° wave | – | Other: Artificial intelligence for the prediction of clinical outcomesHospitalized patients for COVID19 pneumonia during the second wave (OCT-DEC 2020) |
| COVID-19 3° wave | – | Other: Artificial intelligence for the prediction of clinical outcomesHospitalized patients for COVID19 pneumonia during the third wave (GEN-MAY 2021) |
| COVID-19 4° wave | – | Other: Artificial intelligence for the prediction of clinical outcomesHospitalized patients for COVID19 pneumonia during the fourth wave (NOV 2021-MAR 2022) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For each patient, information will be collected regarding: * Personal data (i.e. age, sex, nationality); * Date of hospitalization and discharge (or death) * Comorbidities; * Treatments undertaken for Covid19; * Possible vaccination for Covid19, date and number of doses; * Possible onset of secondary infections and/or complications; * Blood chemistry tests upon admission
Key inclusion criteria (2 listed)
- Age > 18 years;
- Hospitalization for COVID-19 pneumonia at ASST Lecco.
Key exclusion criteria (1 listed)
- Hospitalization or finding of asymptomatic SARS CoV-2 infection.
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 |
|---|---|---|
| Artificial intelligence for the prediction of clinical outcomesUse of artificial intelligence (AI) for the prediction of clinical outcomes such as death and complications in patients hospitalized for COVID pneumonia during the 4 pandemic waves | Other | COVID-19 1° wave, COVID-19 2° wave, COVID-19 3° wave, COVID-19 4° wave |
Primary outcome
Construction of predictive models
Time frame: 6 months
Construction of predictive models to evaluate clinical outcomes such as death and/or onset of secondary infection based on the data collected relating to the 4 COVID-19 waves.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
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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 COVID-19 Pandemic, run by Azienda Ospedaliera di Lecco 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 2 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 23 May 2024. 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?
Contact Stefania Piconi, MD (+390341489890, s.piconi@asst-lecco.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Construction of predictive models (time frame: 6 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 23 May 2024.