跳至主要内容
临床试验/NCT05398731
NCT05398731Unknown不适用

Risk of COVID 19 Disease Among Hypertensive Patients Using Angiotensin Converting Enzyme Inhibitors or Angiotensin Receptor Blockers At Assiut University Hospitals

Assiut University0 个研究点目标入组 400 人开始时间: 2022年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
主要终点
determine the risk of COVID -19 in patients who use ACEI and ARBS

研究概览

简要总结

  1. To determine the risk of COVID -19 in patients who use ACEI and ARBS
  2. To determine the Effect of ACEI and ARBS on COVID -19 infection .
  3. To determine the Severity of COVID -19 in patients who use ACEI and ARBS .

详细描述

SARS -CORONA VIRUS -2 (COVID-19 disease) is an infectious disease caused by the SARS-CoV-2 virus The virus enters the body through the nose, eyes, or mouth. The spike protein binds specifically to the ACE2 receptors present on the type 2 pneumocytes in the alveoli in the lungs . (Fehr and Perlman, 2015) The binding of the ACE2 receptor allows the entry of the virus into the host cell .

The virus enters the host cell either by direct cell entry by membrane fusion or by endocytosis .(Wang , et al. 2008).

ACE inhibitors (angiotensin converting enzyme inhibitors) work by preventing angiotensin I from converting into angiotensin II. (Byrd,et al. 2019)

ARBs (Angiotensin receptor blockers)reduce the action of the hormone angiotensin II, by blocking receptors that the hormone acts on, specifically AT1 receptors, which are found in the heart, blood vessels and kidneys. (Byrd,et al. 2019) ACE inhibitors and ARBs are used to treat high blood pressure and congestive heart failure, to prevent kidney failure in patients with high blood pressure or diabetes, and to reduce the risk of stroke. (Byrd,et al. 2019) Continued use of ACEI/ARB has become controversial in the setting of COVID-19. The reason for this controversy stems from the fact that ACEIs and ARBs use may increase the expression of ACE2 receptor in animal-based studies, which is the known cellular receptor and a necessary entry point for SARS-COV-2 infection, as it has been indicated that ACE2 expression is downregulated following SARS infection, resulting in excessive activation of RAS and exacerbated pneumonia progression.(Peng Zhang.et al.april2020) It has rather been suggested that despite increasing ACE2 levels, ACE inhibitors and ARBs may rather play a protective role. ACEI, by reducing the conversion of angiotensin I (ATI) to angiotensin II (ATII) and ARBs, by reducing the binding of ATII to angiotensin I receptor may tilt the scale suggested by Bombardini et al. in favour of a protective ACE2-signalling pathway .( Bombardini T, Picano E.2020).

Reynolds et.al (2020)found no association between ACE inhibitors and ARBs and increase likelihood of a positive test for covid- 19 or its severity. (Reynolds et.al (2020) However, due to lack of sufficient clinical data supporting either the beneficial or harmful effects of ACEI/ARBs use in patients with COVID-19, the optimal strategy for the management of hypertension in COVID-19 is uncertain and remains to be elucidated. So The aim of this observational study was to determine the association between hypertensive patients using ACEI/ARBs and morbidity and mortality of COVID-19.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years old.
  • patients who use ACEI
  • patients who use ARBs
  • patients who use other antihypertensive drugs(for example ca channel blockers or Beta blockers)
  • Non hypertensive persons with matched age and sex

排除标准

  • < 18 years old.
  • Pregnant or breast-feeding patients.
  • Patients with autoimmune disease.
  • Patients with multi organ failure, active cancer, renal insufficiency or chronic kidney disease.
  • Patients received immunosuppressive drugs.
  • Immune compromised patients.
  • Patients with obstructive lung disease

结局指标

主要结局

determine the risk of COVID -19 in patients who use ACEI and ARBS

时间窗: from begining of Covid_19 pandemic up till now

determine the risk of COVID -19 in patients who use ACEI and ARBS

次要结局

  • determine the morbidity and Severity of COVID -19 in patients who use ACEI and ARBS(from begining of Covid_19 pandemic up till now)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Samar Mohamed Abd Alwahab Abd Alhafz

Resident doctor

Assiut University

相似试验