COVID-19NCT05205707
Association of Circulating ACE2 Levels With COVID-19
An observational study of COVID-19 and COVID-19 Respiratory Infection, run by Jordan University Hospital at 1 site in Jordan.
Trial summary
COVID-19 cases are rising substantially in Jordan. Since this is a novel virus, there is still much to be investigated surrounding its pathophysiology in order to attempt to find suitable treatments or better decision-making in the prognosis of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, COVID-19 Respiratory Infection
- What is being tested?
- ACE serum levels
- How many people
- 261 participants
- Where
- 1 siteJordan
- Study dates
- 1 Jan 2022to 21 Jan 2022
- 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 years and older
- All sexes
- Adult, Older adult
Study population: All adult COVID 19 patients admitted to Jordan University Hospital during 3 months.
Who may be able to join
- Age: 18 and above
- Gender: both males and females.
- Confirmed diagnosis of COVID-19 for patients and confirmed absence of COVID-19
Who cannot join
- Healthy individuals: not being diagnosed with COVID-19 or at least has not been in close contact with a person diagnosed with COVID-19.
Trial locations and contacts
1 site in 1 country.
About this study
COVID-19 cases are rising substantially in Jordan. Since this is a novel virus, there is still much to be investigated surrounding its pathophysiology in order to attempt to find suitable treatments or better decision-making in the prognosis of the disease. This project aims to identify if soluble angiotensin-converting enzyme (ACE2) can be used as a prognostic factor for COVID-19 severity, which will allow clinicians to manage COVID-19 cases more efficiently. ACE2 is of interest since the coronavirus enters host cells through ACE2 receptors. It can slo be hypothesized that the irus may also bind to soluble ACE2, but without mediating its effects. It si, therefore, expected that those with higher levels of ACE2 would more likely have milder disease. This can potentially help improve survival rate, allowing clinicians to identify the higher-risk patients and monitoring them more closely.
Read the detailed description
SARS-CoV-2 is a new isolate of coronavirus that caused an epidemic in Wuhan, China in December 2019. The virus has then spread to the rest of the world causing a pandemic, and the disease the virus causes was designated the name COVID-19.
The presence of underlying medical condition increases a risk of severe disease course. Diabetes and cardiovascular disease are amongst the conditions that are associated with the worst COVID-19 prognosis . Renal failure is also associated with more severe illness On another note, angiotensin-converting enzyme 2 (ACE2) is expressed in human airway epithelia, lung parenchyma, small intestine cells as well as in the heart, kidneys and testis It functions as both an enzyme and a receptor for viral entry as it is known that SARS-CoV-2 enters into human host cells mainly through the cellular receptor ACE2, . It is hypothesized that with the damage and loss of cells induced by infection, enzymatic ACE2 activity would be globally compromised, inducing a state of relative ACE2 deficiency. This leads to enhanced and protracted tissue and vessel exposure to Ang II and therefore vasoconstriction, enhanced thrombosis, increased tissue permeability and cytokine production resulting in inflammation Chronic angiotensin 1 receptor (AT1R) blockade elevates ACE2 expression . Unlike ACE1, however, ACE2 is insensitive to the actions mediated by ACE inhibitors . It might be appealing to propose that chronic use of ACE inhibitors or AT1R antagonists puts patients at particular high risk if they get infected with SARS-CoV-2, as ACE2 overexpression may facilitate viral replication in the lung tissue . However, results of some studies performed in healthy human subjects did not confirm such results. In vitro studies, on the other hand, depict reduced concentrations of soluble ACE2 despite the increase in membrane expression and tissue levels. Therefore, there is no current significant evidence regarding the effects of ACE inhibitors and ARBs on COVID-19 infection .
In contrast, mild or moderate ACE2 deficiency is unlikely to be protective from viral invasion either. This is due to the intrinsically high affinity of SARS-CoV-2 to ACE2 receptors The soluble form of ACE2 may be a biomarker of severity of COVID-19 progression in patients . This could be due to the fact that COVID-19 binds to the soluble form, leaving less to be bound to the ACE2 receptor and be taken up by host cells The aim of this project is to identify any association between ACE2 levels with severity of COVID-19.
- Conditions
- COVID-19, COVID-19 Respiratory Infection
- Being tested
- ACE serum levels
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACE serum levelsDiagnostic test
Circulating ACE2 level will be measured
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 Patients | Blood sample from admitted patients will be drawn Receives: Diagnostic Test: ACE serum levels | |
| Control Patients | Blood sample from control group will be drawn Receives: Diagnostic Test: ACE serum levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACE2 level
Serum level of ACE2 in control and COVID 19 patients will be measured
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start1 Jan 2022
- Primary completion20 Jan 2022
- Study completion21 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amjad Banihani, Jordan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205707
- Sponsor's protocol ID
- 2021/5
- Status last verified
- Jan 2022
- First submitted
- 22 Jan 2022
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Circulating ACE2 Levels With COVID-19
- ClinicalTrials.gov ID
- NCT05205707
- Acronym / sponsor ID
- 2021/5
- Conditions
- COVID-19, COVID-19 Respiratory Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Jordan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 21 Jan 2022 (actual)
- First posted
- 25 Jan 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.
COVID-19 cases are rising substantially in Jordan. Since this is a novel virus, there is still much to be investigated surrounding its pathophysiology in order to attempt to find suitable treatments or better decision-making in the prognosis of the disease. This project aims to identify if soluble angiotensin-converting enzyme (ACE2) can be used as a prognostic factor for COVID-19 severity, which will allow clinicians to manage COVID-19 cases more efficiently. ACE2 is of interest since the coronavirus enters host cells through ACE2 receptors. It can slo be hypothesized that the irus may also bind to soluble ACE2, but without mediating its effects. It si, therefore, expected that those with higher levels of ACE2 would more likely have milder disease. This can potentially help improve survival rate, allowing clinicians to identify the higher-risk patients and monitoring them more closely.
Detailed description
SARS-CoV-2 is a new isolate of coronavirus that caused an epidemic in Wuhan, China in December 2019. The virus has then spread to the rest of the world causing a pandemic, and the disease the virus causes was designated the name COVID-19.
The presence of underlying medical condition increases a risk of severe disease course. Diabetes and cardiovascular disease are amongst the conditions that are associated with the worst COVID-19 prognosis . Renal failure is also associated with more severe illness On another note, angiotensin-converting enzyme 2 (ACE2) is expressed in human airway epithelia, lung parenchyma, small intestine cells as well as in the heart, kidneys and testis It functions as both an enzyme and a receptor for viral entry as it is known that SARS-CoV-2 enters into human host cells mainly through the cellular receptor ACE2, . It is hypothesized that with the damage and loss of cells induced by infection, enzymatic ACE2 activity would be globally compromised, inducing a state of relative ACE2 deficiency. This leads to enhanced and protracted tissue and vessel exposure to Ang II and therefore vasoconstriction, enhanced thrombosis, increased tissue permeability and cytokine production resulting in inflammation Chronic angiotensin 1 receptor (AT1R) blockade elevates ACE2 expression . Unlike ACE1, however, ACE2 is insensitive to the actions mediated by ACE inhibitors . It might be appealing to propose that chronic use of ACE inhibitors or AT1R antagonists puts patients at particular high risk if they get infected with SARS-CoV-2, as ACE2 overexpression may facilitate viral replication in the lung tissue . However, results of some studies performed in healthy human subjects did not confirm such results. In vitro studies, on the other hand, depict reduced concentrations of soluble ACE2 despite the increase in membrane expression and tissue levels. Therefore, there is no current significant evidence regarding the effects of ACE inhibitors and ARBs on COVID-19 infection .
In contrast, mild or moderate ACE2 deficiency is unlikely to be protective from viral invasion either. This is due to the intrinsically high affinity of SARS-CoV-2 to ACE2 receptors The soluble form of ACE2 may be a biomarker of severity of COVID-19 progression in patients . This could be due to the fact that COVID-19 binds to the soluble form, leaving less to be bound to the ACE2 receptor and be taken up by host cells The aim of this project is to identify any association between ACE2 levels with severity of COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covid-19 Patients | – | Diagnostic Test: ACE serum levelsBlood sample from admitted patients will be drawn |
| Control Patients | – | Diagnostic Test: ACE serum levelsBlood sample from control group will be drawn |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All adult COVID 19 patients admitted to Jordan University Hospital during 3 months.
Key inclusion criteria (3 listed)
- Age: 18 and above
- Gender: both males and females.
- Confirmed diagnosis of COVID-19 for patients and confirmed absence of COVID-19
Key exclusion criteria (1 listed)
- Healthy individuals: not being diagnosed with COVID-19 or at least has not been in close contact with a person diagnosed with COVID-19.
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 |
|---|---|---|
| ACE serum levelsCirculating ACE2 level will be measured | Diagnostic test | Control Patients, Covid-19 Patients |
Primary outcome
ACE2 level
Time frame: 3 months
Serum level of ACE2 in control and COVID 19 patients will be measured
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and COVID-19 Respiratory Infection, run by Jordan University Hospital at 1 site in Jordan.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACE2 level (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2022.