Impact of the Genetic Polymorphism on COVID-19 in Egypt

COVID-19 Clinical Trial

Official title:

Impact of the Genetic Polymorphism on the Severity of COVID-19 Infection in Egyptian Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05157217
• Other study ID #: N-134-2020
• Status: Recruiting
• Start date: December 15, 2021
• Est. completion date: September 15, 2022

Study information

• Verified date: July 2022
• Source: Cairo University
• Contact: Naglaa S Bazan, PhD
• Phone: 01005807504
• Email: naglaabazan[@]cu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: September 15, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
Egypt	Cairo University Hospitals	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Cairo University	Misr International University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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 — View Citation

Hoffmann M, Kleine-Weber H, Schroeder S, Krüger N, Herrler T, Erichsen S, Schiergens TS, Herrler G, Wu NH, Nitsche A, Müller MA, Drosten C, Pöhlmann S. SARS-CoV-2 Cell Entry Depends on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven Protease Inhibi — View Citation

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 — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACE I/D gene polymorphism (rs4343)	Genotypic and allele frequencies of the studied SNPS in both study groups	3 months
Primary	Angiotensin-converting enzyme 2 (ACE2) gene polymorphism (rs908004)	Genotypic and allele frequencies of the studied SNPS in both study groups	3 months
Primary	Type 2 transmembrane serine protease (TMPRSS2) gene polymorphism (rs12329760)	Genotypic and allele frequencies of the studied SNPS in both study groups	3 months
Secondary	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	3 months