Clinical trial NCT05157217: Impact of the Genetic Polymorphism on COVID-19 in Egypt
Official title: Impact of the Genetic Polymorphism on the Severity of COVID-19 Infection in Egyptian Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: COVID-19
Genetic Polymorphism
Pharmacogenetics
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Misr International University
First posted: 2021-12-14
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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.

Primary outcomes:
measure: ACE I/D gene polymorphism (rs4343)
timeFrame: 3 months
measure: Angiotensin-converting enzyme 2 (ACE2) gene polymorphism (rs908004)
timeFrame: 3 months
measure: Type 2 transmembrane serine protease (TMPRSS2) gene polymorphism (rs12329760)
timeFrame: 3 months
Secondary outcomes:
measure: Potential interaction between ACE (I/D), ACE2 and TMPRSS2 gene polymorphisms and the occurrences of severe complications in patients with COVID-19 disease.1
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Hospitals
Study officials:
affiliation: Cairo University
name: Naglaa S Bazan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Khaled Farouk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Al-Azhar University in Cairo
name: Adel RA Abdallah, PhD
role: STUDY_CHAIR
affiliation: Misr International University
name: Abdelrahman A Abdelgawad, BScPharm
role: PRINCIPAL_INVESTIGATOR
affiliation: Misr International University
name: Neven MA Sarhan, PhD
role: STUDY_DIRECTOR
affiliation: Al-Azhar University in Cairo
name: Raed SA Ismail, PhD
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Mohamed GL El-Ansary, MD
role: STUDY_DIRECTOR
affiliation: Misr International University
name: Mona Schaalan, PhD
role: STUDY_DIRECTOR
References:
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