COVID-19 DiseaseNCT04347369
A Retrospective Study of Neural Network Model to Dynamically Quantificate the Severity in COVID-19 Disease
An observational study of COVID-19 Disease, run by Xinqiao Hospital of Chongqing at 1 site in China.
Trial summary
The research aim to collect large samples of COVID-19 disease patients with clinical symptoms, laboratory and imaging examination data. Screening the biological indicators which are related to the occurrence of severe diseases. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19 Disease
- What is being tested?
- other
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 17 Jan 2020to 31 Dec 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 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients of COVID-19 disease
Who may be able to join
- Patients of COVID-19 disease confirmed by virus nucleic acid RT-PCR and CT
Who cannot join
- unconfirmed suspected cases
- Patients during pregnancy and lactation
- incomplete clinical data
- inestigators considered patients ineligible for the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: a Retrospective Study of Neural Network Model to Dynamically Quantificate the Severity in COVID-19 Disease
The research aim to collect large samples of COVID-19 disease patients with clinical symptoms, laboratory and imaging examination data. Screening the biological indicators which are related to the occurrence of severe diseases. Then, investigators using artificial intelligence (AI) technology deep learning method to find a prediction model that can dynamically quantify COVID-19 disease severity.
- Conditions
- COVID-19 Disease
- Being tested
- other
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
otherOther
clinical diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Observed group | The patients who were detected COVID-19 disease by RT-PCR and CT imaging. Receives: Other: other |
What is being measured
The primary outcome is the main question the study is designed to answer.
discrimination
The performance of our prediction model is evaluated with the receiver operating characteristic (ROC) curves, areas under the curves (AUCs) and concordance index (c-index).
Measured: up to 3 months
Calibration
The calibration curves analysis is used to show error between the predicted clinical phenotype with prediction model and actual clinical phenotype.
Measured: up to 3 months
Net benefit
Decision curve analysis was used to determine whether the models could be considered useful tools for clinical decisionmaking by comparing the net benefits at any threshold.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start17 Jan 2020
- Primary completion30 Aug 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 DiseaseStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianguo Sun, Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347369
- Sponsor's protocol ID
- XQonc-015
- Status last verified
- Feb 2024
- First submitted
- 18 Mar 2020
- Last updated
- 23 Feb 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 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Retrospective Study of Neural Network Model to Dynamically Quantificate the Severity in COVID-19 Disease
- ClinicalTrials.gov ID
- NCT04347369
- Acronym / sponsor ID
- XQonc-015
- Conditions
- COVID-19 Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 15 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 research aim to collect large samples of COVID-19 disease patients with clinical symptoms, laboratory and imaging examination data. Screening the biological indicators which are related to the occurrence of severe diseases. Then, investigators using artificial intelligence (AI) technology deep learning method to find a prediction model that can dynamically quantify COVID-19 disease severity.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observed group | – | Other: otherThe patients who were detected COVID-19 disease by RT-PCR and CT imaging. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients of COVID-19 disease
Key inclusion criteria (1 listed)
- Patients of COVID-19 disease confirmed by virus nucleic acid RT-PCR and CT
Key exclusion criteria (4 listed)
- unconfirmed suspected cases
- Patients during pregnancy and lactation
- incomplete clinical data
- inestigators considered patients ineligible for the trial
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 |
|---|---|---|
| otherclinical diagnosis | Other | Observed group |
Primary outcome
discrimination
Time frame: up to 3 months
The performance of our prediction model is evaluated with the receiver operating characteristic (ROC) curves, areas under the curves (AUCs) and concordance index (c-index).
Calibration
Time frame: up to 3 months
The calibration curves analysis is used to show error between the predicted clinical phenotype with prediction model and actual clinical phenotype.
Net benefit
Time frame: up to 3 months
Decision curve analysis was used to determine whether the models could be considered useful tools for clinical decisionmaking by comparing the net benefits at any threshold.
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 23 Feb 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.
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 Disease, run by Xinqiao Hospital of Chongqing at 1 site in China.
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 4 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 23 Feb 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 China. 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?
discrimination (time frame: up to 3 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 23 Feb 2024.