Prognositc Factors in COVID-19 Patients Complicated With Hypertension

2019-nCoV Clinical Trial

Official title:

Prognostic Characteristics Difference Between the Hypertension Patients With and Without ACEI Treatment When Suffered With 2019-nCoV Infection in China

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04272710
• Other study ID #: 2020-02
• Status: Withdrawn
• Start date: January 25, 2020
• Est. completion date: April 30, 2020

Study information

• Verified date: March 2020
• Source: Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

There are currently no clinical studies reporting clinical characteristics difference between the hypertension patients with and without ACEI treatment when suffered with novel coronavirus infection in China.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 30, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• 2019-nCoV
• Hypertension

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occupancy rate in the intensive care unit (ICU)	The percentage of patients admitted to the ICU at any time during the 28 days of onset COVID-19.	up to 28 days
Primary	Mechanical Ventilation	The number of patients requiring mechanical ventilation.	up to 28 days
Primary	Death	The number of patients who died of 2019-nCoV infection.	up to 28 days
Secondary	All cause mortality	The number of died 2019-nCoV infected patients from any cause.	up to 28 days
Secondary	Time from onset of symptoms to main outcome and its components	Time from onset of symptoms to admitted to the ICU, requiring mechanical ventilation, and death.	up to 28 days
Secondary	Time to Clinical Recovery	Time to Clinical Recovery	up to 28 days