Impact of the Genetic Polymorphism on COVID-19 in Egypt

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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COVID-19

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>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<br>COVID-19 patients who suffered from serious respiratory complications that needed hospitalization or admission to the ICU | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Genetic Polymorphism, Pharmacogenetics