- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04292964
Prognostic Factors of Patients With COVID-19
March 13, 2020 updated by: Dongying Zhang, Chongqing Medical University
The outbreak of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in China has been declared a public health emergency of international concern.
Despite lower mortality rate, SARS-CoV-2 has killed more people than SARS and MERS and the number keeps growing.
Epidemic studies have been well described clinical features of patients with COVID-19, with the disease severity being an independent predictor of poor outcome.
However, there is still no research investigating the prognostic factors of patients with COVID-19.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
201
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Chongqing, China
- The First Affiliated Hospital of Chongqing Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with COVID-19
Description
Inclusion Criteria:
- Adult aged >=18years old;
- Diagnosed with CONVID19. Diagnostic criteria including: Laboratory (RT-PCR) confirmed SARS-Cov-2 infection; CT of the lung conformed to the manifestation of viral pneumonia.
- Criteria for severe or critical ill conditions: Respiratory rate >=30/min; or Rest SPO2<=93%; or PaO2/FiO2<=300mmHg.
Exclusion Criteria:
- Near-death state (expected survival time less than 24 hours);
- Malignant tumor;
- Pregnancy or puerperium women;
- Patients who refused to participant.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
all-cause mortality
Time Frame: 30 days
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30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
all-cause mortality
Time Frame: 15 days
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15 days
|
|
Severe state
Time Frame: 15 days
|
Criteria for severe or critical ill conditions: Respiratory rate >=30/min; or Rest SPO2<=93%; or PaO2/FiO2<=300mmHg.
|
15 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wen XS, Jiang D, Gao L, Zhou JZ, Xiao J, Cheng XC, He B, Chen Y, Lei P, Tan XW, Qin S, Zhang DY. Clinical characteristics and predictive value of lower CD4+T cell level in patients with moderate and severe COVID-19: a multicenter retrospective study. BMC Infect Dis. 2021 Jan 12;21(1):57. doi: 10.1186/s12879-020-05741-w.
- Gao L, Jiang D, Wen XS, Cheng XC, Sun M, He B, You LN, Lei P, Tan XW, Qin S, Cai GQ, Zhang DY. Prognostic value of NT-proBNP in patients with severe COVID-19. Respir Res. 2020 Apr 15;21(1):83. doi: 10.1186/s12931-020-01352-w.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2020
Primary Completion (Actual)
March 13, 2020
Study Completion (Actual)
March 13, 2020
Study Registration Dates
First Submitted
March 1, 2020
First Submitted That Met QC Criteria
March 1, 2020
First Posted (Actual)
March 3, 2020
Study Record Updates
Last Update Posted (Actual)
March 17, 2020
Last Update Submitted That Met QC Criteria
March 13, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 2020-02-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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