Angiotensin Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Risk of COVID_19

NCT ID: NCT05398731

Last Updated: 2022-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-30

Study Completion Date

2023-05-31

Brief Summary

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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 .

Detailed Description

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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.

Conditions

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COVID-19 Pneumonia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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patients received ACEI

patient who use ACEI ( Duration, type of response, and the time period between the begining of and the emergence of symptoms of COVID-19)

Covid_19

Intervention Type OTHER

Duration, type of response, and the time period between the begining of drug and the emergence of symptoms of COVID-19

patients received ARBs

patient who use ARBs ( Duration, type of response, and the time period between the begining of and the emergence of symptoms of COVID-19)

Covid_19

Intervention Type OTHER

Duration, type of response, and the time period between the begining of drug and the emergence of symptoms of COVID-19

other antihypertensive drugs

patient who use other antihypertensive drugs(for example ca channel blockers and Beta blockers) ( Duration, type of response, and the time period between the begining of and the emergence of symptoms of COVID-19)

Covid_19

Intervention Type OTHER

Duration, type of response, and the time period between the begining of drug and the emergence of symptoms of COVID-19

non hypertensive group

Non hypertensive persons with matched age and sex

Covid_19

Intervention Type OTHER

Duration, type of response, and the time period between the begining of drug and the emergence of symptoms of COVID-19

Interventions

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Covid_19

Duration, type of response, and the time period between the begining of drug and the emergence of symptoms of COVID-19

Intervention Type OTHER

Other Intervention Names

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ARBs ca channel blockers Beta blockers

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

1. \< 18 years old.
2. Pregnant or breast-feeding patients.
3. Patients with autoimmune disease.
4. Patients with multi organ failure, active cancer, renal insufficiency or chronic kidney disease.
5. Patients received immunosuppressive drugs.
6. Immune compromised patients.
7. Patients with obstructive lung disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Samar Mohamed Abd Alwahab Abd Alhafz

Resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hanan M Adawy Nafeh, PhD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

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Hanan M Adawy Nafeh, professor

Role: CONTACT

01003053369

Rasha M Shehata, Lecturer

Role: CONTACT

01061607834

References

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Fehr AR, Perlman S. Coronaviruses: an overview of their replication and pathogenesis. Methods Mol Biol. 2015;1282:1-23. doi: 10.1007/978-1-4939-2438-7_1.

Reference Type BACKGROUND
PMID: 25720466 (View on PubMed)

Wang H, Yang P, Liu K, Guo F, Zhang Y, Zhang G, Jiang C. SARS coronavirus entry into host cells through a novel clathrin- and caveolae-independent endocytic pathway. Cell Res. 2008 Feb;18(2):290-301. doi: 10.1038/cr.2008.15.

Reference Type BACKGROUND
PMID: 18227861 (View on PubMed)

Byrd, James Brian; Ram, C. Venkata S.; Lerma, Edgar V. 2019

Reference Type BACKGROUND

Peng Zhang, Lihua Zhu, Jingjing Cai, Fang Lei, Juan-Juan Qin, Jing Xie, Ye-Mao Liu, Yan-Ci Zhao, Xuewei Huang, Lijin Lin, Meng Xia, Ming-Ming Chen, Xu Cheng, Xiao Zhang, Deliang Guo, Yuanyuan Peng, Yan-Xiao Ji, Jing Chen, Zhi-Gang She, Yibin Wang, Qingbo Xu, Renfu Tan, Haitao Wang, Jun Lin, Pengcheng Luo, Shouzhi Fu, Hongbin Cai, Ping Ye, Bing Xiao, Weiming Mao, Liming Liu, Youqin Yan, Mingyu Liu, Manhua Chen, Xiao-Jing Zhang, Xinghuan Wang, Rhian M. Touyz, Jiahong Xia, Bing-Hong Zhang, Xiaodong Huang, Yufeng Yuan, Rohit Loomba, Peter P. Liu, and Hongliang Li.April 2020

Reference Type BACKGROUND

Bombardini T, Picano E. Angiotensin-Converting Enzyme 2 as the Molecular Bridge Between Epidemiologic and Clinical Features of COVID-19. Can J Cardiol. 2020 May;36(5):784.e1-784.e2. doi: 10.1016/j.cjca.2020.03.026. Epub 2020 Mar 29. No abstract available.

Reference Type BACKGROUND
PMID: 32299780 (View on PubMed)

Reynolds HR, Adhikari S, Pulgarin C, Troxel AB, Iturrate E, Johnson SB, Hausvater A, Newman JD, Berger JS, Bangalore S, Katz SD, Fishman GI, Kunichoff D, Chen Y, Ogedegbe G, Hochman JS. Renin-Angiotensin-Aldosterone System Inhibitors and Risk of Covid-19. N Engl J Med. 2020 Jun 18;382(25):2441-2448. doi: 10.1056/NEJMoa2008975. Epub 2020 May 1.

Reference Type BACKGROUND
PMID: 32356628 (View on PubMed)

Other Identifiers

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ACEI,ARBS and risk of COVID_19

Identifier Type: -

Identifier Source: org_study_id

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