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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04292327
Other study ID # KY-2020-24.01
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date July 31, 2020

Study information

Verified date February 2020
Source Fujian Provincial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 400
Est. completion date July 31, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Fujian Provincial Hospital Fuzhou Fujian

Sponsors (1)

Lead Sponsor Collaborator
Fujian Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality The mortality of COVID-19 in 28 days 28 day
Primary The time interval of Nucleic acid detection become negative The time interval of COVID-19 form nucleic acid confirmed to the nucleic acid detection turn into negative. 28 day