PneumonitisNCT04302688
Accurate Classification System for Patients With COVID-19 Pneumonitis
An observational study of Pneumonitis, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial summary
The COVID-19 has a clustering morbidity trend and older people with chronic diseases are more likely to die, such as chronic renal insufficiency and chronic cardiovascular disease. We set up a COVID-19 pneumonia grading scale. The COVID-19 score system was validated to predict the clinical outcome of a patient. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pneumonitis
- How many people
- 669 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2019to 4 Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with novel coronavirus pneumonia, and all cases were collected from the People's Hospital of Wuhan University.
Who may be able to join
- Patients with novel coronavirus pneumonia should be examined and diagnosed by CT and swab test of viral nucleic acid.
Who cannot join
- Patients who should have died during the course of the disease, but the cause of death was unrelated to viral pneumonia.
- Suspected patient review refers to the negative nucleic acid test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accurate Classification System for Patients With COVID-19 Based on Prognostic Nomogram
The COVID-19 has a clustering morbidity trend and older people with chronic diseases are more likely to die, such as chronic renal insufficiency and chronic cardiovascular disease. We set up a COVID-19 pneumonia grading scale. The COVID-19 score system was validated to predict the clinical outcome of a patient.
Read the detailed description
- First we collect the medical records, according to the time sequence, the patients were divided into two groups, one is the model group, and the other is the validate group.
- Responsible for the risk factor of regression equation according to the model. The patients were divided into three groups according to their total score of risk responsibility.
- Compared with SEPSIS and CURB-65 grading system with the grading system we established.
- Conditions
- Pneumonitis
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| modeling cohort | The 445 patients were grouped in chronological order. | |
| validating colort | The remaining 224 patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival status
survival status as of February 24, 2020
Measured: 10 December 2019 to 10 February 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start10 Dec 2019
- Primary completion10 Feb 2020
- Study completion4 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumonitisStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 669 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gong Qiong, Renmin Hospital of Wuhan University
- Investigators
- Qiong Gong, MD., Principal investigator, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302688
- Sponsor's protocol ID
- COVID-19 WU1
- Status last verified
- Mar 2020
- First submitted
- 7 Mar 2020
- Last updated
- 10 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not going to share for the time being.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accurate Classification System for Patients With COVID-19 Based on Prognostic Nomogram
- ClinicalTrials.gov ID
- NCT04302688
- Acronym / sponsor ID
- COVID-19 WU1
- Conditions
- Pneumonitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 669 participants (actual)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 4 Mar 2020 (actual)
- First posted
- 10 Mar 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 COVID-19 has a clustering morbidity trend and older people with chronic diseases are more likely to die, such as chronic renal insufficiency and chronic cardiovascular disease. We set up a COVID-19 pneumonia grading scale. The COVID-19 score system was validated to predict the clinical outcome of a patient.
Detailed description
- First we collect the medical records, according to the time sequence, the patients were divided into two groups, one is the model group, and the other is the validate group.
- Responsible for the risk factor of regression equation according to the model. The patients were divided into three groups according to their total score of risk responsibility.
- Compared with SEPSIS and CURB-65 grading system with the grading system we established.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modeling cohort | – | –The 445 patients were grouped in chronological order. |
| validating colort | – | –The remaining 224 patients. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with novel coronavirus pneumonia, and all cases were collected from the People's Hospital of Wuhan University.
Key inclusion criteria (1 listed)
- Patients with novel coronavirus pneumonia should be examined and diagnosed by CT and swab test of viral nucleic acid.
Key exclusion criteria (2 listed)
- Patients who should have died during the course of the disease, but the cause of death was unrelated to viral pneumonia.
- Suspected patient review refers to the negative nucleic acid 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 |
|---|---|---|
| Other | modeling cohort, validating colort |
Primary outcome
survival status
Time frame: 10 December 2019 to 10 February 2020
survival status as of February 24, 2020
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 10 Mar 2020.
- Individual participant dataSharing planned: No. Not going to share for the time being.
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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.
Qiong Gong, MD. principal investigator
Renmin Hospital of Wuhan University
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 Pneumonitis, run by Renmin Hospital of Wuhan University 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 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 10 Mar 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 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?
survival status (time frame: 10 December 2019 to 10 February 2020). 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 10 Mar 2020.