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

Sponsor
Fujian Provincial Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04292327
Collaborator
(none)
400
Enrollment
1
Location
7
Anticipated Duration (Months)
57.4
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated 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 :
    Jan 1, 2020
    Anticipated Primary Completion Date :
    Apr 30, 2020
    Anticipated Study Completion Date :
    Jul 31, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Primary Outcome Measures

    1. Mortality [28 day]

      The mortality of COVID-19 in 28 days

    2. The time interval of Nucleic acid detection become negative [28 day]

      The time interval of COVID-19 form nucleic acid confirmed to the nucleic acid detection turn into negative.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Locations

    Site City State Country Postal Code
    1 Fujian Provincial Hospital Fuzhou Fujian China 350000

    Sponsors and Collaborators

    • Fujian Provincial Hospital

    Investigators

    • Principal Investigator: Xiuling Shang, Fujian Provincial Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xiuling Shang, associate chief physician, Fujian Provincial Hospital
    ClinicalTrials.gov Identifier:
    NCT04292327
    Other Study ID Numbers:
    • KY-2020-24.01
    First Posted:
    Mar 3, 2020
    Last Update Posted:
    Mar 3, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xiuling Shang, associate chief physician, Fujian Provincial Hospital
    2019-novel coronavirus
    Pneumonia
    Additional relevant MeSH terms:
    Pneumonia
    Coronavirus Infections

    Study Results

    No Results Posted as of Mar 3, 2020