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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04272710
Other study ID # 2020-02
Secondary ID
Status Withdrawn
Phase
First received
Last updated
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
Health authority
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Status Withdrawn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.

Study Design


Related Conditions & MeSH terms


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
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