COVID-19 PneumoniaNCT05398731
Angiotensin Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Risk of COVID_19
An observational study of COVID-19 Pneumonia, run by Assiut University.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Covid_19
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- < 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Risk of COVID 19 Disease Among Hypertensive Patients Using Angiotensin Converting Enzyme Inhibitors or Angiotensin Receptor Blockers At Assiut University Hospitals
- To determine the risk of COVID -19 in patients who use ACEI and ARBS
- To determine the Effect of ACEI and ARBS on COVID -19 infection .
- 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.
- Conditions
- COVID-19 Pneumonia
- Being tested
- Covid_19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covid_19Other
Also called ARBs, ca channel blockers, Beta blockers
Duration, type of response, and the time period between the begining of drug and the emergence of symptoms of COVID-19
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: Other: Covid_19 | |
| non hypertensive group | Non hypertensive persons with matched age and sex Receives: Other: Covid_19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: from begining of Covid_19 pandemic up till now
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study startJun 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Mohamed Abd Alwahab Abd Alhafz, Assiut University
- Investigators
- Hanan M Adawy Nafeh, PhD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398731
- Sponsor's protocol ID
- ACEI,ARBS and risk of COVID_19
- Status last verified
- May 2022
- First submitted
- 19 May 2022
- Last updated
- 7 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 25720466Wang 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 18227861Byrd, 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 32299780Reynolds 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of COVID 19 Disease Among Hypertensive Patients Using Angiotensin Converting Enzyme Inhibitors or Angiotensin Receptor Blockers At Assiut University Hospitals
- ClinicalTrials.gov ID
- NCT05398731
- Acronym / sponsor ID
- ACEI,ARBS and risk of COVID_19
- Conditions
- COVID-19 Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To determine the risk of COVID -19 in patients who use ACEI and ARBS
- To determine the Effect of ACEI and ARBS on COVID -19 infection .
- To determine the Severity of COVID -19 in patients who use ACEI and ARBS .
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| patients received ACEI | – | Other: Covid_19patient who use ACEI ( Duration, type of response, and the time period between the begining of and the emergence of symptoms of COVID-19) |
| patients received ARBs | – | Other: Covid_19patient who use ARBs ( Duration, type of response, and the time period between the begining of and the emergence of symptoms of COVID-19) |
| other antihypertensive drugs | – | Other: Covid_19patient 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) |
| non hypertensive group | – | Other: Covid_19Non hypertensive persons with matched age and sex |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- < 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Covid_19Also: ARBs, ca channel blockers, Beta blockersDuration, type of response, and the time period between the begining of drug and the emergence of symptoms of COVID-19 | Other | non hypertensive group, other antihypertensive drugs, patients received ACEI, patients received ARBs |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Background: PubMed 25720466Fehr 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.
- Background: PubMed 18227861Wang 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.
- BackgroundByrd, James Brian; Ram, C. Venkata S.; Lerma, Edgar V. 2019
- BackgroundPeng 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
- Background: PubMed 32299780Bombardini 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.
- Background: PubMed 32356628Reynolds 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanan M Adawy Nafeh, PhD principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pneumonia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanan M Adawy Nafeh, professor (01003053369, Hmnafeh@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
determine the risk of COVID -19 in patients who use ACEI and ARBS (time frame: from begining of Covid_19 pandemic up till now). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05398731, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2022.