- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04292327
Clinical Progressive Characteristics and Treatment Effects of 2019-novel Coronavirus (2019-nCoV)
Clinical Progressive Characteristics and Treatment Effects of 2019-novel Coronavirus(2019-nCoV)
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Fujian
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Fuzhou, Fujian, Kina, 350000
- Fujian Provincial Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion criteria.
- 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)
Exclusion criteria.
- 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Andet
- Tidsperspektiver: Tilbagevirkende kraft
Kohorter og interventioner
Gruppe / kohorte |
|---|
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The ordinary COVID-19
Consistent with the diagnosis of ordinary COVID-19.
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The heavy COVID-19.
Consistent with the diagnosis of heavy COVID-19.
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The critical COVID-19
Consistent with the diagnosis of critical COVID-19
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Mortality
Tidsramme: 28 day
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The mortality of COVID-19 in 28 days
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28 day
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The time interval of Nucleic acid detection become negative
Tidsramme: 28 day
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The time interval of COVID-19 form nucleic acid confirmed to the nucleic acid detection turn into negative.
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28 day
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Xiuling Shang, Fujian Provincial Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- KY-2020-24.01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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