Prognositc Factors in COVID-19 Patients Complicated With Hypertension

Withdrawn

• Conditions: 2019-nCoV

• Registration Number: NCT04272710
• Lead Sponsor: Chongqing Medical University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-01-25
• Study First Submitted: 2020-02-12
• Study First Submitted QC: 2020-02-14
• Study First Posted: 2020-02-17
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-13
• Last Update Posted: 2020-03-17
• Primary Completion: 2020-03-31
• Study Completion: 2020-04-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death	up to 28 days	The number of patients who died of 2019-nCoV infection.
Occupancy rate in the intensive care unit (ICU)	up to 28 days	The percentage of patients admitted to the ICU at any time during the 28 days of onset COVID-19.
Mechanical Ventilation	up to 28 days	The number of patients requiring mechanical ventilation.

Secondary Outcome Measures

Name	Time	Method
Time to Clinical Recovery	up to 28 days	Time to Clinical Recovery
All cause mortality	up to 28 days	The number of died 2019-nCoV infected patients from any cause.
Time from onset of symptoms to main outcome and its components	up to 28 days	Time from onset of symptoms to admitted to the ICU, requiring mechanical ventilation, and death.

Trial Locations

Locations (1)

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, China