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Clinical Progressive Characteristics and Treatment Effects of 2019-novel Coronavirus (2019-nCoV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Xiuling Shang, Fujian Provincial Hospital

Study Description
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Brief Summary:

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

Detailed Description:

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 Design
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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Other
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. Mortality [ Time Frame: 28 day ]
    The mortality of COVID-19 in 28 days

  2. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Study Population
Collect COVID-19 patients admitted to Wuhan Infectious Diseases Hospital (Wuhan JinYinTan Hospital) from January 2020 to March 2020
Criteria

Inclusion criteria.

  1. 2019-nCov (SARA-Cov-2) nucleic acid positive detected by PCR.
  2. Older than 18 years old and younger than 75 years old.
  3. Meet the diagnostic criteria of COVID-19 for different types (including ordinary type, heavy type and critical type)

Exclusion criteria.

  1. the age is less than 18 years old;
  2. pregnant or lactating women;
  3. severe underlying diseases, such as advanced malignant tumor, end-stage lung disease, etc.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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China, Fujian
Fujian Provincial Hospital
Fuzhou, Fujian, China, 350000
Sponsors and Collaborators
Fujian Provincial Hospital
Investigators
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Principal Investigator: Xiuling Shang Fujian Provincial Hospital
More Information
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Responsible Party: Xiuling Shang, associate chief physician, Fujian Provincial Hospital
ClinicalTrials.gov Identifier: NCT04292327    
Other Study ID Numbers: KY-2020-24.01
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiuling Shang, Fujian Provincial Hospital:
2019-novel coronavirus
Pneumonia
Additional relevant MeSH terms:
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Pneumonia
Coronavirus Infections
Respiratory Tract Infections
Infections
Lung Diseases
 Respiratory Tract Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases