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

June 5, 2022 updated by: Samar Mohamed Abd Alwahab Abd Alhafz, Assiut University

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

  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 .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hanan M Adawy Nafeh, professor
  • Phone Number: 01003053369
  • Email: Hmnafeh@yahoo.com

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Duration, type of response, and the time period between the begining of drug and the emergence of symptoms of COVID-19
Other Names:
  • Beta blockers
  • ARBs
  • ca channel blockers
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
Duration, type of response, and the time period between the begining of drug and the emergence of symptoms of COVID-19
Other Names:
  • Beta blockers
  • ARBs
  • ca channel blockers
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
Duration, type of response, and the time period between the begining of drug and the emergence of symptoms of COVID-19
Other Names:
  • Beta blockers
  • ARBs
  • ca channel blockers
non hypertensive group
Non hypertensive persons with matched age and sex
Other: Covid_19
Duration, type of response, and the time period between the begining of drug and the emergence of symptoms of COVID-19
Other Names:
  • Beta blockers
  • ARBs
  • ca channel blockers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
determine the risk of COVID -19 in patients who use ACEI and ARBS
Time Frame: from begining of Covid_19 pandemic up till now
determine the risk of COVID -19 in patients who use ACEI and ARBS
from begining of Covid_19 pandemic up till now

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
determine the morbidity and Severity of COVID -19 in patients who use ACEI and ARBS
from begining of Covid_19 pandemic up till now

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Hanan M Adawy Nafeh, PhD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

May 19, 2022

First Submitted That Met QC Criteria

May 30, 2022

First Posted (Actual)

June 1, 2022

Study Record Updates

Last Update Posted (Actual)

June 7, 2022

Last Update Submitted That Met QC Criteria

June 5, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACEI,ARBS and risk of COVID_19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19 Pneumonia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe