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

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.

Study Overview

• Status: Withdrawn
• Conditions: 2019-nCoV

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 Type: Observational

Contacts and Locations

Study Locations

• China
  • Chongqing, China
    • The First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

the hypertension patients with and without ACEI treatment when suffered with novel coronavirus infection in China

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
ACEI treatment; hypertension patients with ACEI treatment when suffered with novel coronavirus infection in China
Control; hypertension patients without ACEI treatment when suffered with novel coronavirus infection in China

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Mechanical Ventilation	The number of patients requiring mechanical ventilation.	up to 28 days
Death	The number of patients who died of 2019-nCoV infection.	up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality	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	Time from onset of symptoms to admitted to the ICU, requiring mechanical ventilation, and death.	up to 28 days
Time to Clinical Recovery	Time to Clinical Recovery	up to 28 days

Collaborators and Investigators

• Sponsor: Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2020
• Primary Completion (Anticipated): March 31, 2020
• Study Completion (Anticipated): April 30, 2020

Study Registration Dates

• First Submitted: February 12, 2020
• First Submitted That Met QC Criteria: February 14, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 13, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 2020-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No