- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04272710
Prognositc Factors in COVID-19 Patients Complicated With Hypertension
Prognostic Characteristics Difference Between the Hypertension Patients With and Without ACEI Treatment When Suffered With 2019-nCoV Infection in China
Studieoversikt
Status
Forhold
Detaljert beskrivelse
At present, the outbreak of the new coronavirus (2019-nCoV) infection in Wuhan and Hubei provinces has attracted great attention from the medical community across the country. Both 2019-nCoV and SARS viruses are coronaviruses, and they have a large homology.
Published laboratory studies have suggested that SARS virus infection and its lung injury are related to angiotensin-converting enzyme 2 (ACE2) in lung tissue. And ACE and ACE2 in the renin-angiotensin system (RAS) are vital central links to maintain hemodynamic stability and normal heart and kidney function in vivo.
A large amount of evidence-based medical evidence shows that ACE inhibitors are the basic therapeutic drugs for maintaining hypertension, reducing the risk of cardiovascular, cerebrovascular, and renal adverse events, improving quality of life, and prolonging life in patients with hypertension. Recent experimental studies suggest that treatment with ACE inhibitors can significantly reduce pulmonary inflammation and cytokine release caused by coronavirus infection.
Studietype
Kontakter og plasseringer
Studiesteder
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Chongqing, Kina
- The First Affiliated Hospital of Chongqing Medical University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Adult aged >=18years old;
- Diagnosed with 2019-nCoV. Diagnostic criteria including: Laboratory (RT-PCR) confirmed 2019-nCoV infection; CT of the lung conformed to the manifestation of viral pneumonia.
- Diagnosed with primary hypertension.
- Criteria for severe or critical ill conditions: Respiratory rate >=30/min; or Rest SPO2<=93%; or PaO2/FiO2<=300mmHg.
Exclusion Criteria:
- Near-death state (expected survival time less than 24 hours);
- Malignant tumor;
- Pregnancy or puerperium women;
- ACEI contraindication
- Patients who refused to participant.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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ACEI treatment
hypertension patients with ACEI treatment when suffered with novel coronavirus infection in China
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Control
hypertension patients without ACEI treatment when suffered with novel coronavirus infection in China
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Occupancy rate in the intensive care unit (ICU)
Tidsramme: up to 28 days
|
The percentage of patients admitted to the ICU at any time during the 28 days of onset COVID-19.
|
up to 28 days
|
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Mechanical Ventilation
Tidsramme: up to 28 days
|
The number of patients requiring mechanical ventilation.
|
up to 28 days
|
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Death
Tidsramme: up to 28 days
|
The number of patients who died of 2019-nCoV infection.
|
up to 28 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
All cause mortality
Tidsramme: up to 28 days
|
The number of died 2019-nCoV infected patients from any cause.
|
up to 28 days
|
|
Time from onset of symptoms to main outcome and its components
Tidsramme: up to 28 days
|
Time from onset of symptoms to admitted to the ICU, requiring mechanical ventilation, and death.
|
up to 28 days
|
|
Time to Clinical Recovery
Tidsramme: up to 28 days
|
Time to Clinical Recovery
|
up to 28 days
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2020-02
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