COVID-19 DiseaseNCT04366024
A Novel Nomogram to Predict Severity of COVID-19
An observational study of COVID-19 Disease and Nomogram Model, run by Xinqiao Hospital of Chongqing at 1 site in China.
Trial summary
Investigators use clinical data from a large sample of COVID-19 disease patients to screen out biomarkers associated with disease severity. Then, a novel nomogram model will be established to predict covid-19 disease severity, which could provide important assistance and supplement for clinical work. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Disease, Nomogram Model
- What is being tested?
- other
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 17 Jan 2020to 31 Dec 2021
- 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
- Adult, Older adult
Study population: COVID-19 disease patients
Who may be able to join
- COVID-19 disease patients confirmed by virus nucleic acid RT-PCR and CT
Who cannot join
- unconfirmed suspected cases
- Patients during pregnancy and lactation
- incomplete clinical data
- investigators considered patients ineligible for the trial
- Child patients
Trial locations and contacts
1 site in 1 country.
China1 site
Xinqiao Hospital of Chongqing
Chongqing, Chongqing Municipality, 400000
About this study
Investigators use clinical data from a large sample of COVID-19 disease patients to screen out biomarkers associated with disease severity. Then, a novel nomogram model will be established to predict covid-19 disease severity, which could provide important assistance and supplement for clinical work. In the case of extremely shortage of front-line medical resources, patients with potential severe diseases will be timely treated with the help of the novel nomogram model.
- Conditions
- COVID-19 Disease, Nomogram Model
- 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 | COVID-19 disease patients who were detected 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.
the consistency of predicted severe rate and observed severe rate of COVID-19 patients
We aim to use the clinical data of COVID-19 patients to construct a nomogram model to predict the severe rate of each patient, then the the consistency of predicted severe rate and observed severe rate will be evaluated by calibration plot.
Measured: up to 3 months
Duration of severe illness
the duration of severe illness of each patient will evaluated
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 posted28 Apr 2020
- Study start17 Jan 2020
- Primary completion30 Aug 2020
- Study completion31 Dec 2021
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
- NCT04366024
- Sponsor's protocol ID
- XQonc-016
- Status last verified
- Feb 2024
- First submitted
- 21 Apr 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 Novel Nomogram to Predict Severity of COVID-19
- ClinicalTrials.gov ID
- NCT04366024
- Acronym / sponsor ID
- XQonc-016
- Conditions
- COVID-19 Disease, Nomogram Model
- 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 2021 (actual)
- First posted
- 28 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.
Investigators use clinical data from a large sample of COVID-19 disease patients to screen out biomarkers associated with disease severity. Then, a novel nomogram model will be established to predict covid-19 disease severity, which could provide important assistance and supplement for clinical work. In the case of extremely shortage of front-line medical resources, patients with potential severe diseases will be timely treated with the help of the novel nomogram model.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observed group | – | Other: otherCOVID-19 disease patients who were detected by RT-PCR and CT imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- COVID-19 disease patients
Key inclusion criteria (1 listed)
- COVID-19 disease patients confirmed by virus nucleic acid RT-PCR and CT
Key exclusion criteria (5 listed)
- unconfirmed suspected cases
- Patients during pregnancy and lactation
- incomplete clinical data
- investigators considered patients ineligible for the trial
- Child patients
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
the consistency of predicted severe rate and observed severe rate of COVID-19 patients
Time frame: up to 3 months
We aim to use the clinical data of COVID-19 patients to construct a nomogram model to predict the severe rate of each patient, then the the consistency of predicted severe rate and observed severe rate will be evaluated by calibration plot.
Duration of severe illness
Time frame: up to 3 months
the duration of severe illness of each patient will evaluated
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 and Nomogram Model, 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 5 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?
the consistency of predicted severe rate and observed severe rate of COVID-19 patients (time frame: up to 3 months). The study lists 2 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.