Clinical Progressive Characteristics and Treatment Effects of 2019-novel Coronavirus (2019-nCoV)
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|ClinicalTrials.gov Identifier: NCT04292327|
Recruitment Status : Unknown
Verified February 2020 by Xiuling Shang, Fujian Provincial Hospital.
Recruitment status was: Active, not recruiting
First Posted : March 3, 2020
Last Update Posted : March 3, 2020
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Objects: The purpose of this study was to observe the characteristics of morbidity, disease progression and therapeutic effects of 2019-novel coronavirus pneumonia patients with different clinical types.
Method: A single center, retrospective and observational study was used to collect COVID-19 patients admitted to Wuhan Infectious Diseases Hospital (Wuhan JinYinTan Hospital) from January 2020 to March 2020. The general information, first clinical symptoms, hospitalization days, laboratory examination, CT examination, antiviral drugs, immune enhancers, traditional Chinese medicine treatment and other clinical intervention measures were recorded, and the nutritional status and prognosis of the patients were recorded. confirm COVID-19 's disease progression, clinical characteristics, disease severity and treatment effects. To compare the characteristics of disease progression, clinical features, disease severity and therapeutic effect of different types of COVID-19.
Outcomes: The characteristics of disease progression, clinical features, disease severity and therapeutic effect of different types of COVID-19.
Conclusion: The characteristics of disease progression, clinical features and therapeutic effect of different types of COVID-19.
|Condition or disease|
|Pneumonia Caused by Human Coronavirus|
Since December 2019, patients with unexplained pneumonia have appeared in some medical institutions in Wuhan, China. Nucleic acid testing was completed on January 10, 2020, which was confirmed to be caused by 2019-novel coronavirus. In 2020, the World Health Organization(WHO) named the virus 2019-novel coronavirus(2019-nCoV). The WHO announced that the pneumonia caused by 2019-nCoV is officially called COVID-19. Today, more than 70,000 cases have been confirmed and more than 2,000 patients have died.
At present, the epidemiological characteristics, laboratory indicators, imaging features and clinical treatment effects of COVID-19 should be reported, but the sample size is small. Large sample studies are still needed to further confirm COVID-19 's disease progression, clinical characteristics, disease severity and treatment effects, so as to provide a scientific basis for future clinical treatment. Therefore, it is particularly important to further review the relationship between the characteristics and prognosis of such patients.
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Clinical Progressive Characteristics and Treatment Effects of 2019-novel Coronavirus(2019-nCoV)|
|Actual Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||July 31, 2020|
The ordinary COVID-19
Consistent with the diagnosis of ordinary COVID-19.
The heavy COVID-19.
Consistent with the diagnosis of heavy COVID-19.
The critical COVID-19
Consistent with the diagnosis of critical COVID-19
- Mortality [ Time Frame: 28 day ]The mortality of COVID-19 in 28 days
- The time interval of Nucleic acid detection become negative [ Time Frame: 28 day ]The time interval of COVID-19 form nucleic acid confirmed to the nucleic acid detection turn into negative.
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|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 2019-nCov (SARA-Cov-2) nucleic acid positive detected by PCR.
- Older than 18 years old and younger than 75 years old.
- Meet the diagnostic criteria of COVID-19 for different types (including ordinary type, heavy type and critical type)
- the age is less than 18 years old;
- pregnant or lactating women;
- severe underlying diseases, such as advanced malignant tumor, end-stage lung disease, etc.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04292327
|Fujian Provincial Hospital|
|Fuzhou, Fujian, China, 350000|
|Principal Investigator:||Xiuling Shang||Fujian Provincial Hospital|
|Responsible Party:||Xiuling Shang, associate chief physician, Fujian Provincial Hospital|
|Other Study ID Numbers:||
|First Posted:||March 3, 2020 Key Record Dates|
|Last Update Posted:||March 3, 2020|
|Last Verified:||February 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Respiratory Tract Infections
Respiratory Tract Diseases
RNA Virus Infections