COVID-19NCT05157217
Impact of the Genetic Polymorphism on COVID-19 in Egypt
An observational study of COVID-19, run by Cairo University at 1 site in Egypt.
Trial summary
The COVID-19 infection severity depends on many factors, including genetic factors. The SNPs of ACE1, ACE2 and TMPRSS2; which have a big role in the viral entry to the cells, will be tested and help establish a relationship between the genetic variation in these SNPs and the severity of the COVID-19 symptoms. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19
- How many people
- 98 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2021to 15 Sep 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Egyptian patients who are either : infected with SARS-CoV-2 and healed without suffering from any respiratory complications or the need for hospitalization Or infected with SARS-CoV-2 who suffered from serious respiratory complications that needed hospitalization or admission to the ICU.
Who may be able to join
- Ø Positive nasal Swap for COVID-19 Infection. Ø Age of 18 years to 80 years. Ø Written informed consent of the subject to participate in the study.
Who cannot join
- Ø Patients with any prior respiratory problems such Asthma and COPD.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University Hospitals
Cairo, 11562
Naglaa S Bazan, PhD, 01005807504 ext. 002, naglaabazan@cu.edu.eg
Khaled Farouk, MD, 01223224570 ext. 002, khaledfarouk.mdccm@gmail.com
About this study
Official title: Impact of the Genetic Polymorphism on the Severity of COVID-19 Infection in Egyptian Patients
The COVID-19 infection severity depends on many factors, including genetic factors. The SNPs of ACE1, ACE2 and TMPRSS2; which have a big role in the viral entry to the cells, will be tested and help establish a relationship between the genetic variation in these SNPs and the severity of the COVID-19 symptoms. The aim of this study is to detect the association between ACE1, ACE2 and TMPRSS2 gene polymorphism variants and occurrences of severe complications in Egyptians patients with COVID-19 disease.
Read the detailed description
The world has been battling with the COVID-19 pandemic since the end of 2019, which is caused by the highly contagious SARS-CoV-2 with over 25 million confirmed cases all around the world. Although it has been the focus of many studies, this new pandemic is still an enigma in many ways. The severity of the symptoms can vary from mild symptoms with flu-like symptoms and self-limiting disease to severe respiratory symptoms that needs hospitalization and ICU admission and can lead to death. Several factors have been speculated to affect the severity of the COVID-19 infection including genetic factors. In this study, we will investigate the variation in three different SNPs, one for the ACE2 gene which is the binding receptor for the SARS-CoV-2 virus (rs908004, consequence: 3 Prime UTR Variant, Alleles: C>G / C>T), one for the ACE (I/D) gene; which can in term affect the ACE2 receptor and the probability for lung injury ( rs4343, Consequence: Synonymous Variant, Alleles: G>A), and one for the TMPRSS2 gene; which is a transmembrane protease which activates the viral spike by priming it when it is attached to the ACE2 receptor ( rs12329760, consequence: Missense Variant, Alleles: C>T), and conclude if they have any effect in the COVID-19 disease severity and need for hospitalization and admission to the ICU. The aim is:
- To detect the incidence of angiotensin-converting enzyme Insertion/Deletion (ACE I/D), angiotensin-converting enzyme 2 (ACE2) and type 2 transmembrane serine protease (TMPRSS2) gene polymorphisms in the Egyptian population.
- To detect association between angiotensin-converting enzyme Insertion/Deletion (ACE I/D) gene polymorphism variants and occurrences of severe complications in patients with COVID-19 disease.
- To detect association between angiotensin-converting enzyme 2 (ACE2) gene polymorphism variants and occurrences of severe complications in patients with COVID-19 disease.
- To detect association between type 2 transmembrane serine protease (TMPRSS2) gene polymorphism variants and occurrences of severe complications in patients with COVID-19 disease.
- To investigate the potential interaction between ACE (I/D), ACE2 and TMPRSS2 gene polymorphisms and the occurrences of severe complications in patients with COVID-19 disease.
- Conditions
- COVID-19
- Keywords
- COVID-19, Genetic Polymorphism, Pharmacogenetics
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | COVID-19 carriers who were infected with SARS-CoV-2 and healed without suffering from any respiratory complications or the need for hospitalization | |
| Group 2 | COVID-19 patients who suffered from serious respiratory complications that needed hospitalization or admission to the ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACE I/D gene polymorphism (rs4343)
Genotypic and allele frequencies of the studied SNPS in both study groups
Measured: 3 months
Angiotensin-converting enzyme 2 (ACE2) gene polymorphism (rs908004)
Genotypic and allele frequencies of the studied SNPS in both study groups
Measured: 3 months
Type 2 transmembrane serine protease (TMPRSS2) gene polymorphism (rs12329760)
Genotypic and allele frequencies of the studied SNPS in both study groups
Measured: 3 months
Secondary outcomes (1)
Potential interaction between ACE (I/D), ACE2 and TMPRSS2 gene polymorphisms and the occurrences of severe complications in patients with COVID-19 disease.1
Genotypic and allele frequencies of all studied SNPS in patients who suffered from serious respiratory complications that needed hospitalization or admission to the ICU
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 posted14 Dec 2021
- Study start15 Dec 2021
- Primary completion15 Aug 2022 (estimated)
- Study completion15 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Cairo 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
- Other
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Misr International University
- Responsible party
- Principal investigator, Naglaa Samir Ahmed Bazan, Cairo University
- Investigators
- Naglaa S Bazan, PhD, Principal investigator, Cairo UniversityKhaled Farouk, MD, Principal investigator, Cairo UniversityAdel RA Abdallah, PhD, Study chair, Al-Azhar University in CairoAbdelrahman A Abdelgawad, BScPharm, Principal investigator, Misr International UniversityNeven MA Sarhan, PhD, Study director, Misr International UniversityRaed SA Ismail, PhD, Study director, Al-Azhar University in CairoMohamed GL El-Ansary, MD, Study director, Cairo UniversityMona Schaalan, PhD, Study director, Misr International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157217
- Sponsor's protocol ID
- N-134-2020
- Status last verified
- Jul 2022
- First submitted
- 11 Dec 2021
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study protocol
Publications
Hoffmann M, Kleine-Weber H, Schroeder S, Kruger N, Herrler T, Erichsen S, Schiergens TS, Herrler G, Wu NH, Nitsche A, Muller MA, Drosten C, Pohlmann S. SARS-CoV-2 Cell Entry Depends on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven Protease Inhibitor. Cell. 2020 Apr 16;181(2):271-280.e8. doi: 10.1016/j.cell.2020.02.052. Epub 2020 Mar 5.
PubMed 32142651Zheng H, Cao JJ. Angiotensin-Converting Enzyme Gene Polymorphism and Severe Lung Injury in Patients with Coronavirus Disease 2019. Am J Pathol. 2020 Oct;190(10):2013-2017. doi: 10.1016/j.ajpath.2020.07.009. Epub 2020 Jul 29.
PubMed 32735889Asselta R, Paraboschi EM, Mantovani A, Duga S. ACE2 and TMPRSS2 variants and expression as candidates to sex and country differences in COVID-19 severity in Italy. Aging (Albany NY). 2020 Jun 5;12(11):10087-10098. doi: 10.18632/aging.103415. Epub 2020 Jun 5.
PubMed 32501810Hou Y, Zhao J, Martin W, Kallianpur A, Chung MK, Jehi L, Sharifi N, Erzurum S, Eng C, Cheng F. New insights into genetic susceptibility of COVID-19: an ACE2 and TMPRSS2 polymorphism analysis. BMC Med. 2020 Jul 15;18(1):216. doi: 10.1186/s12916-020-01673-z.
PubMed 32664879Itoyama S, Keicho N, Quy T, Phi NC, Long HT, Ha LD, Ban VV, Ohashi J, Hijikata M, Matsushita I, Kawana A, Yanai H, Kirikae T, Kuratsuji T, Sasazuki T. ACE1 polymorphism and progression of SARS. Biochem Biophys Res Commun. 2004 Oct 22;323(3):1124-9. doi: 10.1016/j.bbrc.2004.08.208.
PubMed 15381116
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Genetic Polymorphism on the Severity of COVID-19 Infection in Egyptian Patients
- ClinicalTrials.gov ID
- NCT05157217
- Acronym / sponsor ID
- N-134-2020
- Conditions
- COVID-19
- Keywords
- COVID-19, Genetic Polymorphism, Pharmacogenetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Misr International University
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 15 Aug 2022 (estimated)
- Study completion
- 15 Sep 2022 (estimated)
- First posted
- 14 Dec 2021 (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.
The COVID-19 infection severity depends on many factors, including genetic factors. The SNPs of ACE1, ACE2 and TMPRSS2; which have a big role in the viral entry to the cells, will be tested and help establish a relationship between the genetic variation in these SNPs and the severity of the COVID-19 symptoms. The aim of this study is to detect the association between ACE1, ACE2 and TMPRSS2 gene polymorphism variants and occurrences of severe complications in Egyptians patients with COVID-19 disease.
Detailed description
The world has been battling with the COVID-19 pandemic since the end of 2019, which is caused by the highly contagious SARS-CoV-2 with over 25 million confirmed cases all around the world. Although it has been the focus of many studies, this new pandemic is still an enigma in many ways. The severity of the symptoms can vary from mild symptoms with flu-like symptoms and self-limiting disease to severe respiratory symptoms that needs hospitalization and ICU admission and can lead to death. Several factors have been speculated to affect the severity of the COVID-19 infection including genetic factors. In this study, we will investigate the variation in three different SNPs, one for the ACE2 gene which is the binding receptor for the SARS-CoV-2 virus (rs908004, consequence: 3 Prime UTR Variant, Alleles: C>G / C>T), one for the ACE (I/D) gene; which can in term affect the ACE2 receptor and the probability for lung injury ( rs4343, Consequence: Synonymous Variant, Alleles: G>A), and one for the TMPRSS2 gene; which is a transmembrane protease which activates the viral spike by priming it when it is attached to the ACE2 receptor ( rs12329760, consequence: Missense Variant, Alleles: C>T), and conclude if they have any effect in the COVID-19 disease severity and need for hospitalization and admission to the ICU. The aim is:
- To detect the incidence of angiotensin-converting enzyme Insertion/Deletion (ACE I/D), angiotensin-converting enzyme 2 (ACE2) and type 2 transmembrane serine protease (TMPRSS2) gene polymorphisms in the Egyptian population.
- To detect association between angiotensin-converting enzyme Insertion/Deletion (ACE I/D) gene polymorphism variants and occurrences of severe complications in patients with COVID-19 disease.
- To detect association between angiotensin-converting enzyme 2 (ACE2) gene polymorphism variants and occurrences of severe complications in patients with COVID-19 disease.
- To detect association between type 2 transmembrane serine protease (TMPRSS2) gene polymorphism variants and occurrences of severe complications in patients with COVID-19 disease.
- To investigate the potential interaction between ACE (I/D), ACE2 and TMPRSS2 gene polymorphisms and the occurrences of severe complications in patients with COVID-19 disease.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –COVID-19 carriers who were infected with SARS-CoV-2 and healed without suffering from any respiratory complications or the need for hospitalization |
| Group 2 | – | –COVID-19 patients who suffered from serious respiratory complications that needed hospitalization or admission to the ICU |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Egyptian patients who are either : infected with SARS-CoV-2 and healed without suffering from any respiratory complications or the need for hospitalization Or infected with SARS-CoV-2 who suffered from serious respiratory complications that needed hospitalization or admission to the ICU.
Key inclusion criteria (1 listed)
- Ø Positive nasal Swap for COVID-19 Infection. Ø Age of 18 years to 80 years. Ø Written informed consent of the subject to participate in the study.
Key exclusion criteria (1 listed)
- Ø Patients with any prior respiratory problems such Asthma and COPD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ACE I/D gene polymorphism (rs4343)
Time frame: 3 months
Genotypic and allele frequencies of the studied SNPS in both study groups
Angiotensin-converting enzyme 2 (ACE2) gene polymorphism (rs908004)
Time frame: 3 months
Genotypic and allele frequencies of the studied SNPS in both study groups
Type 2 transmembrane serine protease (TMPRSS2) gene polymorphism (rs12329760)
Time frame: 3 months
Genotypic and allele frequencies of the studied SNPS in both study groups
1 secondary outcome
Potential interaction between ACE (I/D), ACE2 and TMPRSS2 gene polymorphisms and the occurrences of severe complications in patients with COVID-19 disease.1
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Results publication: PubMed 32142651Hoffmann M, Kleine-Weber H, Schroeder S, Kruger N, Herrler T, Erichsen S, Schiergens TS, Herrler G, Wu NH, Nitsche A, Muller MA, Drosten C, Pohlmann S. SARS-CoV-2 Cell Entry Depends on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven Protease Inhibitor. Cell. 2020 Apr 16;181(2):271-280.e8. doi: 10.1016/j.cell.2020.02.052. Epub 2020 Mar 5.
- Results publication: PubMed 32735889Zheng H, Cao JJ. Angiotensin-Converting Enzyme Gene Polymorphism and Severe Lung Injury in Patients with Coronavirus Disease 2019. Am J Pathol. 2020 Oct;190(10):2013-2017. doi: 10.1016/j.ajpath.2020.07.009. Epub 2020 Jul 29.
- Results publication: PubMed 32501810Asselta R, Paraboschi EM, Mantovani A, Duga S. ACE2 and TMPRSS2 variants and expression as candidates to sex and country differences in COVID-19 severity in Italy. Aging (Albany NY). 2020 Jun 5;12(11):10087-10098. doi: 10.18632/aging.103415. Epub 2020 Jun 5.
- Results publication: PubMed 32664879Hou Y, Zhao J, Martin W, Kallianpur A, Chung MK, Jehi L, Sharifi N, Erzurum S, Eng C, Cheng F. New insights into genetic susceptibility of COVID-19: an ACE2 and TMPRSS2 polymorphism analysis. BMC Med. 2020 Jul 15;18(1):216. doi: 10.1186/s12916-020-01673-z.
- Results publication: PubMed 15381116Itoyama S, Keicho N, Quy T, Phi NC, Long HT, Ha LD, Ban VV, Ohashi J, Hijikata M, Matsushita I, Kawana A, Yanai H, Kirikae T, Kuratsuji T, Sasazuki T. ACE1 polymorphism and progression of SARS. Biochem Biophys Res Commun. 2004 Oct 22;323(3):1124-9. doi: 10.1016/j.bbrc.2004.08.208.
- Individual participant dataSharing planned: Undecided. Study protocol
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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.
Naglaa S Bazan, PhD principal investigator
Cairo University
Khaled Farouk, MD principal investigator
Cairo University
Adel RA Abdallah, PhD study chair
Al-Azhar University in Cairo
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, run by Cairo University at 1 site in Egypt.
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 1 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: status not confirmed, as of the sponsor's last update on 27 Jul 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naglaa S Bazan, PhD (01005807504 ext. 002, naglaabazan@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACE I/D gene polymorphism (rs4343) (time frame: 3 months). The study lists 3 primary outcomes in all. 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 NCT05157217, which also lists 5 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 27 Jul 2022.