COVID-19NCT04365634
A Single-center Retrospective Study to Find Prediction Factors Related to Mortality of COVID-19 Patients.
An observational study of COVID-19, run by Tongji Hospital at 1 site in China.
Trial summary
In the single-centered, retrospective study, 306 hospital patients (including 129 diabetes and 177 non-diabetes patients) confirmed with SARS-CoV-2 infection were enrolled in Tongji Hospital, Wuhan, China. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19
- Type of treatment
- Pill or oral medicine
- How many people
- 306 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2020to 1 Apr 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: The patients admitted from Feb 2, 2020 to Feb 15, 2020, diagnosed with SARS-CoV-2 pneumonia according to interim guidance of National health commission of the people's republic of China were enrolled. Laboratory confirmed cases were identified with positive viral RNA by real-time RT-PCR detection by the local health authority or our hospital from specimen taken from throat or nasal swab.
Who may be able to join
- Patients admitted from Feb 2, 2020 to Feb 15, 2020, diagnosed with SARS-CoV-2 pneumonia according to interim guidance of National health commission of the people's republic of China.
Who cannot join
- With SARS-CoV-2 RNA detection negative results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center Retrospective Study to Find Prediction Factors Related to Mortality of COVID-19 Patients by Univariate and Multivariate Analysis.
In the single-centered, retrospective study, 306 hospital patients (including 129 diabetes and 177 non-diabetes patients) confirmed with SARS-CoV-2 infection were enrolled in Tongji Hospital, Wuhan, China. Clinical characteristics including clinical manifestation, laboratory parameters, lung CT features and clinical outcomes were compared between diabetes and non-diabetes patients. The prediction factors were analyzed for mortality of COVID-19 by univariate and multivariate analysis.
- Conditions
- COVID-19
- 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 |
|---|---|---|
| Diabetes | Diabetes mellitus was diagnosed according to the standards of American Diabetes Association which were briefly described as FPG ≥ 7.0 mmol/L (Fasting is defined as no caloric intake for at least 8 h) or 2-h plasma glucose ≥ 11.1 mmol/L during Oral glucose tolerance test (OGTT), or with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose (RPG) ≥ 11.1 mmol/L. And in this group, we have 129 COVID-19 patients with diabetes. | |
| Non-diabetes | Patients who do not meet the American Diabetes Association's standard diagnosis of diabetes are defined as non-diabetes. And in this group, we have 177 COVID-19 patients without diabetes. | |
| Survivors | COVID-19 patients who survived on the 28th day in hospital belong to survivors group. In the survivors group, we included 201 patients with complete data. | |
| Non-survivors | COVID-19 patients who did not survive on the 28th day in hospital belong to non-survivors group. In the non-survivors group, we included 54 patients with complete data. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Find the prediction factors associated with hospitalized death of patients with COVID-19 by univariate and multivariate analysis
Measured: 28 days
Secondary outcomes (3)
Demographics and clinical characteristics
Measured: 28 days
Laboratory parameters and radiography image features
Measured: 28 days
Treatment, complications and clinical outcomes
Measured: 28 days
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 start2 Feb 2020
- Primary completion15 Mar 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qin Ning, Tongji Hospital
- Investigators
- Meifang Han, Professor, Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365634
- Sponsor's protocol ID
- TJ20200202
- Status last verified
- Apr 2020
- First submitted
- 25 Apr 2020
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Han M, Ma K, Wang X, Yan W, Wang H, You J, Wang Q, Chen H, Guo W, Chen T, Ning Q, Luo X. Immunological Characteristics in Type 2 Diabetes Mellitus Among COVID-19 Patients. Front Endocrinol (Lausanne). 2021 Mar 11;12:596518. doi: 10.3389/fendo.2021.596518. eCollection 2021.
PubMed 33776910
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Retrospective Study to Find Prediction Factors Related to Mortality of COVID-19 Patients by Univariate and Multivariate Analysis.
- ClinicalTrials.gov ID
- NCT04365634
- Acronym / sponsor ID
- TJ20200202
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 2 Feb 2020 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 1 Apr 2020 (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.
In the single-centered, retrospective study, 306 hospital patients (including 129 diabetes and 177 non-diabetes patients) confirmed with SARS-CoV-2 infection were enrolled in Tongji Hospital, Wuhan, China. Clinical characteristics including clinical manifestation, laboratory parameters, lung CT features and clinical outcomes were compared between diabetes and non-diabetes patients. The prediction factors were analyzed for mortality of COVID-19 by univariate and multivariate analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Diabetes | – | –Diabetes mellitus was diagnosed according to the standards of American Diabetes Association which were briefly described as FPG ≥ 7.0 mmol/L (Fasting is defined as no caloric intake for at least 8 h) or 2-h plasma glucose ≥ 11.1 mmol/L during Oral glucose tolerance test (OGTT), or with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose (RPG) ≥ 11.1 mmol/L. And in this group, we have 129 COVID-19 patients with diabetes. |
| Non-diabetes | – | –Patients who do not meet the American Diabetes Association's standard diagnosis of diabetes are defined as non-diabetes. And in this group, we have 177 COVID-19 patients without diabetes. |
| Survivors | – | –COVID-19 patients who survived on the 28th day in hospital belong to survivors group. In the survivors group, we included 201 patients with complete data. |
| Non-survivors | – | –COVID-19 patients who did not survive on the 28th day in hospital belong to non-survivors group. In the non-survivors group, we included 54 patients with complete data. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients admitted from Feb 2, 2020 to Feb 15, 2020, diagnosed with SARS-CoV-2 pneumonia according to interim guidance of National health commission of the people's republic of China were enrolled. Laboratory confirmed cases were identified with positive viral RNA by real-time RT-PCR detection by the local health authority or our hospital from specimen taken from throat or nasal swab.
Key inclusion criteria (1 listed)
- Patients admitted from Feb 2, 2020 to Feb 15, 2020, diagnosed with SARS-CoV-2 pneumonia according to interim guidance of National health commission of the people's republic of China.
Key exclusion criteria (1 listed)
- With SARS-CoV-2 RNA detection negative results.
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
Find the prediction factors associated with hospitalized death of patients with COVID-19 by univariate and multivariate analysis
Time frame: 28 days
3 secondary outcomes
Demographics and clinical characteristics
Time frame: 28 days
Laboratory parameters and radiography image features
Time frame: 28 days
Treatment, complications and clinical outcomes
Time frame: 28 days
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 28 Apr 2020.
- Derived from this study: PubMed 33776910Han M, Ma K, Wang X, Yan W, Wang H, You J, Wang Q, Chen H, Guo W, Chen T, Ning Q, Luo X. Immunological Characteristics in Type 2 Diabetes Mellitus Among COVID-19 Patients. Front Endocrinol (Lausanne). 2021 Mar 11;12:596518. doi: 10.3389/fendo.2021.596518. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
Meifang Han, Professor study chair
Tongji Hospital
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, run by Tongji Hospital 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 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: finished, as of the sponsor's last update on 28 Apr 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?
Find the prediction factors associated with hospitalized death of patients with COVID-19 by univariate and multivariate analysis (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04365634, which also lists 1 linked publication.
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 28 Apr 2020.