Prognositc Factors in COVID-19 Patients Complicated With Hypertension

• ClinicalTrials.gov Identifier: NCT04272710
• Recruitment Status: Withdrawn
• First Posted: February 17, 2020
• Last Update Posted: March 17, 2020
• Sponsor: Chongqing Medical University
• Information provided by (Responsible Party): Dongying Zhang, Chongqing Medical University

Study Description

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.

Condition or disease
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 Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Prognostic Characteristics Difference Between the Hypertension Patients With and Without ACEI Treatment When Suffered With 2019-nCoV Infection in China
• Actual Study Start Date: January 25, 2020
• Estimated Primary Completion Date: March 31, 2020
• Estimated Study Completion Date: April 30, 2020

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

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.

Contacts and Locations

Locations

China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Sponsors and Collaborators

Chongqing Medical University

More Information

• Responsible Party: Dongying Zhang, Associate Professor, Chongqing Medical University
• ClinicalTrials.gov Identifier: NCT04272710
• Other Study ID Numbers: 2020-02
• First Posted: February 17, 2020
• Last Update Posted: March 17, 2020
• Last Verified: March 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases