CClinicalTrials.gg
Status unknownNCT05398731Updated Jun 7, 2022

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

An observational study in COVID-19 Pneumonia, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-06-07.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
400
Ages
18 Years to 90 Years
Sex
All
01

Study summary

  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 .
Read the detailed description

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.

02

Conditions studied

  • COVID-19 Pneumonia

Browse trials for

03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 400 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

questionnaire with 5 Domain:

  1. Personal and demographic data, socioeconomic status. and other co comorbid diseases.
  2. Included patients(groups)
  3. Adherence of the patients to precautions against SARS-COV2.
  4. SARS-CoV-2 infection:
  5. Post COVID- 19 symptoms.
  6. any investigation with the pt

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

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
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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)

    Other: 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)

    Other: 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)

    Other: Covid_19

  • non hypertensive group

    Non hypertensive persons with matched age and sex

    Other: Covid_19

Interventions

  • OtherCovid_19

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

    Also known as: ARBs, ca channel blockers, Beta blockers

06

What researchers measure

Primary outcomes

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

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

    Time frame: from begining of Covid_19 pandemic up till now

Secondary outcomes

  1. determine the morbidity and Severity of COVID -19 in patients who use ACEI and ARBS

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

    Time frame: from begining of Covid_19 pandemic up till now

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 25720466 ↗
  • 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. PubMed 18227861 ↗
  • Byrd, James Brian; Ram, C. Venkata S.; Lerma, Edgar V. 2019
  • 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
  • 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. PubMed 32299780 ↗
  • 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. PubMed 32356628 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05398731
Lead sponsor
Assiut University
Responsible party
Samar Mohamed Abd Alwahab Abd Alhafz (Resident doctor, Assiut University) — Principal investigator
First posted
Jun 1, 2022
Start date
Jun 2022 (estimated)
Primary completion
Mar 2023 (estimated)
Completion
May 2023 (estimated)
Last update
Jun 7, 2022

Study contacts

Hanan M Adawy Nafeh, professor
Contact
Hmnafeh@yahoo.com
01003053369
Rasha M Shehata, Lecturer
Contact
Rashahamed@aun.edu.eg
01061607834
Hanan M Adawy Nafeh, PhD
principal investigator · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion