Clinical trial NCT04272710: Prognositc Factors in COVID-19 Patients Complicated With Hypertension
Official title: Prognostic Characteristics Difference Between the Hypertension Patients With and Without ACEI Treatment When Suffered With 2019-nCoV Infection in China
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: 2019-nCoV
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the hypertension patients with and without ACEI treatment when suffered with novel coronavirus infection in China

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.

Eligibility 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.

Primary outcomes:
measure: Occupancy rate in the intensive care unit (ICU)
timeFrame: up to 28 days
measure: Mechanical Ventilation
timeFrame: up to 28 days
measure: Death
timeFrame: up to 28 days
Secondary outcomes:
measure: All cause mortality
timeFrame: up to 28 days
measure: Time from onset of symptoms to main outcome and its components
timeFrame: up to 28 days
measure: Time to Clinical Recovery
timeFrame: up to 28 days
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
Study officials:
References: