Impact of the Genetic Polymorphism on COVID-19 in Egypt

NCT ID: NCT05157217

Last Updated: 2022-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 98 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-15
• Study Completion Date: 2022-09-15

Brief 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. 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.

Conditions

COVID-19

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

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

No interventions assigned to this group

Group 2

COVID-19 patients who suffered from serious respiratory complications that needed hospitalization or admission to the ICU

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

Ø Patients with any prior respiratory problems such Asthma and COPD.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Misr International University

OTHER

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Naglaa Samir Ahmed Bazan

Ass. Professor and Acting Head of Clinical Pharmacy Department - Cairo University Hospitals

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Naglaa S Bazan, PhD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Khaled Farouk, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Adel RA Abdallah, PhD

Role: STUDY_CHAIR

Al-Azhar University in Cairo

Abdelrahman A Abdelgawad, BScPharm

Role: PRINCIPAL_INVESTIGATOR

Misr International University

Neven MA Sarhan, PhD

Role: STUDY_DIRECTOR

Misr International University

Raed SA Ismail, PhD

Role: STUDY_DIRECTOR

Al-Azhar University in Cairo

Mohamed GL El-Ansary, MD

Role: STUDY_DIRECTOR

Cairo University

Mona Schaalan, PhD

Role: STUDY_DIRECTOR

Misr International University

Locations

Cairo University Hospitals

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Naglaa S Bazan, PhD

Role: CONTACT

naglaabazan@cu.edu.eg

01005807504 ext. 002

Abdelrahman A Abdelgawad, BScPharm

Role: CONTACT

abdelrahman114549@miuegypt.edu.eg

01119110322 ext. 002

Facility Contacts

Naglaa S Bazan, PhD

Role: primary

naglaabazan@cu.edu.eg

01005807504 ext. 002

Khaled Farouk, MD

Role: backup

khaledfarouk.mdccm@gmail.com

01223224570 ext. 002

References

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.

Reference Type: RESULT

PMID: 32142651 (View on PubMed)

Zheng 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.

Reference Type: RESULT

PMID: 32735889 (View on PubMed)

Asselta 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.

Reference Type: RESULT

PMID: 32501810 (View on PubMed)

Hou 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.

Reference Type: RESULT

PMID: 32664879 (View on PubMed)

Itoyama 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.

Reference Type: RESULT

PMID: 15381116 (View on PubMed)

Other Identifiers

N-134-2020

Identifier Type: -

Identifier Source: org_study_id