2019 Novel Coronavirus DiseaseOCCP-HPNCT05615792
Observational Cohort of COVID-19 Patients in Hubei Province
An observational study of 2019 Novel Coronavirus Disease, run by Dao Wen Wang at 1 site in China.
Trial summary
This study intends to use the relevant case data of COVID-19 in Hubei Province, using big data processing and mining methods to evaluate the effects of clinical indicators, drug use and genes on the clinical prognosis of COVID-19 patients, so as to provide a theoretical basis for the treatment of these diseases and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 2019 Novel Coronavirus Disease
- How many people
- 68,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2020to 1 Mar 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: This study is a hospital-based observational study initiated by Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology. Trained researchers are responsible for screening and joining the group. About 6,8000 COVID-19 patients in Hubei Province were expected to be included in this study. Patients enrolled in the group will undergo baseline survey and follow-up according to the program.
Who may be able to join
- Age ≥ 18, regardless of gender;
- A history of epidemiology, including travel or residence in high-risk areas or other communities with case reports within 14 days before the onset of the disease, or have a history of contact with novel coronavirus infection (those who are positive for nucleic acid tests); or patients with fever or respiratory symptoms from the community with case reports; or aggregative onset;
- Corresponding clinical manifestations, including respiratory symptoms such as fever, with typical imaging features of COVID-19, normal or decreased white blood cell count and decreased lymphocyte count in the early stage of the disease;
- Clear etiological evidence, including real-time fluorescent RT-PCR detection of novel coronavirus nucleic acid positive, or viral gene sequencing, is highly homologous to novel coronavirus.
Who cannot join
- Patients who meet any of the following criteria cannot be enrolled in this study:
- Patients refused to participate in this study;
- According to the researchers, patients are unable to complete this study or comply with the requirements of this study (due to management or other reasons).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Cohort of The Effects of Clinical Indicators, Drug Use and Genotypes on The Clinical Prognosis of COVID-19 Patients in Hubei Province
This study intends to use the relevant case data of COVID-19 in Hubei Province, using big data processing and mining methods to evaluate the effects of clinical indicators, drug use and genes on the clinical prognosis of COVID-19 patients, so as to provide a theoretical basis for the treatment of these diseases and reduce the mortality.
Read the detailed description
Hubei Province, as the forefront of the fight against epidemic, has the largest number of patients infected with SARS-CoV-2 and the highest quality medical data. However, so far, these data have not been fully analyzed, if these data can not be mined and used, it will be a great loss to the whole human race. By fully mining and analyzing these data, we can sum up a large number of experiences related to COVID-19, summarize various laws of this kind of disease, and provide clinical evidence based on large samples for the research of this disease, eventually contribute China's experience to the global fight against the epidemic.
Based on the above background, this study intends to use the relevant case data of COVID-19 in Hubei Province, using big data processing and mining methods to evaluate the effects of clinical indicators, drug use and genes on the clinical prognosis of COVID-19 patients, so as to provide a theoretical basis for the treatment of these diseases and reduce the mortality.
- Conditions
- 2019 Novel Coronavirus Disease
- Being tested
- No intervention
- Keywords
- COVID-19, SARS-CoV-2, Risk Factors, Mortality
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| patients with coronavirus disease 2019 (COVID-19) | Patients diagnosed with COVID-19 in Hubei Province Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Numbers and dates of death in each group
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 Feb 2020
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 2019 Novel Coronavirus 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dao Wen Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dao Wen Wang, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615792
- Sponsor's protocol ID
- TJ-COVID
- Acronym
- OCCP-HP
- Status last verified
- Mar 2024
- First submitted
- 10 Nov 2022
- Last updated
- 7 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li D, He W, Yu B, Wang DW, Ni L. NT-proBNP ratio is a potential predictor for COVID-19 outcomes in adult Chinese patients: a retrospective study. Sci Rep. 2024 Mar 11;14(1):5906. doi: 10.1038/s41598-024-56329-2.
PubMed 38467760Xu K, He W, Yu B, Zhong K, Zhou D, Wang DW. Beneficial Effects of Angiotensin II Receptor Blockers on Mortality in Patients with COVID-19: A Retrospective Study from 2019 to 2020 in China. Cardiovasc Drugs Ther. 2025 Feb;39(1):63-74. doi: 10.1007/s10557-023-07494-5. Epub 2023 Aug 11.
PubMed 37566218
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Cohort of The Effects of Clinical Indicators, Drug Use and Genotypes on The Clinical Prognosis of COVID-19 Patients in Hubei Province
- ClinicalTrials.gov ID
- NCT05615792
- Acronym / sponsor ID
- OCCP-HP / TJ-COVID
- Conditions
- 2019 Novel Coronavirus Disease
- Keywords
- COVID-19, SARS-CoV-2, Risk Factors, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68,000 participants (actual)
- Lead sponsor
- Dao Wen WangUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 14 Nov 2022 (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.
This study intends to use the relevant case data of COVID-19 in Hubei Province, using big data processing and mining methods to evaluate the effects of clinical indicators, drug use and genes on the clinical prognosis of COVID-19 patients, so as to provide a theoretical basis for the treatment of these diseases and reduce the mortality.
Detailed description
Hubei Province, as the forefront of the fight against epidemic, has the largest number of patients infected with SARS-CoV-2 and the highest quality medical data. However, so far, these data have not been fully analyzed, if these data can not be mined and used, it will be a great loss to the whole human race. By fully mining and analyzing these data, we can sum up a large number of experiences related to COVID-19, summarize various laws of this kind of disease, and provide clinical evidence based on large samples for the research of this disease, eventually contribute China's experience to the global fight against the epidemic.
Based on the above background, this study intends to use the relevant case data of COVID-19 in Hubei Province, using big data processing and mining methods to evaluate the effects of clinical indicators, drug use and genes on the clinical prognosis of COVID-19 patients, so as to provide a theoretical basis for the treatment of these diseases and reduce the mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with coronavirus disease 2019 (COVID-19) | – | Other: No interventionPatients diagnosed with COVID-19 in Hubei Province |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is a hospital-based observational study initiated by Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology. Trained researchers are responsible for screening and joining the group. About 6,8000 COVID-19 patients in Hubei Province were expected to be included in this study. Patients enrolled in the group will undergo baseline survey and follow-up according to the program.
Key inclusion criteria (4 listed)
- Age ≥ 18, regardless of gender;
- A history of epidemiology, including travel or residence in high-risk areas or other communities with case reports within 14 days before the onset of the disease, or have a history of contact with novel coronavirus infection (those who are positive for nucleic acid tests); or patients with fever or respiratory symptoms from the community with case reports; or aggregative onset;
- Corresponding clinical manifestations, including respiratory symptoms such as fever, with typical imaging features of COVID-19, normal or decreased white blood cell count and decreased lymphocyte count in the early stage of the disease;
- Clear etiological evidence, including real-time fluorescent RT-PCR detection of novel coronavirus nucleic acid positive, or viral gene sequencing, is highly homologous to novel coronavirus.
Key exclusion criteria (3 listed)
- Patients refused to participate in this study;
- According to the researchers, patients are unable to complete this study or comply with the requirements of this study (due to management or other reasons).
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 |
|---|---|---|
| No interventionNo intervention | Other | patients with coronavirus disease 2019 (COVID-19) |
Primary outcome
All-cause mortality
Time frame: 2 years
Numbers and dates of death in each group
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 7 Mar 2024.
- Derived from this study: PubMed 38467760Li D, He W, Yu B, Wang DW, Ni L. NT-proBNP ratio is a potential predictor for COVID-19 outcomes in adult Chinese patients: a retrospective study. Sci Rep. 2024 Mar 11;14(1):5906. doi: 10.1038/s41598-024-56329-2.
- Derived from this study: PubMed 37566218Xu K, He W, Yu B, Zhong K, Zhou D, Wang DW. Beneficial Effects of Angiotensin II Receptor Blockers on Mortality in Patients with COVID-19: A Retrospective Study from 2019 to 2020 in China. Cardiovasc Drugs Ther. 2025 Feb;39(1):63-74. doi: 10.1007/s10557-023-07494-5. Epub 2023 Aug 11.
- Individual participant dataSharing planned: Undecided
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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 2019 Novel Coronavirus Disease, run by Dao Wen Wang 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 4 inclusion and 3 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 7 Mar 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?
All-cause mortality (time frame: 2 years). 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 NCT05615792, which also lists 2 linked publications.
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 7 Mar 2024.