Impact of the Genetic Polymorphism on COVID-19 in Egypt

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05157217
Collaborator
Misr International University (Other)
98
1
9
10.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    98 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Other
    Official Title:
    Impact of the Genetic Polymorphism on the Severity of COVID-19 Infection in Egyptian Patients
    Actual Study Start Date :
    Dec 15, 2021
    Anticipated Primary Completion Date :
    Aug 15, 2022
    Anticipated Study Completion Date :
    Sep 15, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. ACE I/D gene polymorphism (rs4343) [3 months]

      Genotypic and allele frequencies of the studied SNPS in both study groups

    2. Angiotensin-converting enzyme 2 (ACE2) gene polymorphism (rs908004) [3 months]

      Genotypic and allele frequencies of the studied SNPS in both study groups

    3. Type 2 transmembrane serine protease (TMPRSS2) gene polymorphism (rs12329760) [3 months]

      Genotypic and allele frequencies of the studied SNPS in both study groups

    Secondary Outcome Measures

    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 [3 months]

      Genotypic and allele frequencies of all studied SNPS in patients who suffered from serious respiratory complications that needed hospitalization or admission to the ICU

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cairo University Hospitals Cairo Egypt 11562

    Sponsors and Collaborators

    • Cairo University
    • Misr International University

    Investigators

    • Principal Investigator: Naglaa S Bazan, PhD, Cairo University
    • Principal Investigator: Khaled Farouk, MD, Cairo University
    • Study Chair: Adel RA Abdallah, PhD, Al-Azhar University in Cairo
    • Principal Investigator: Abdelrahman A Abdelgawad, BScPharm, Misr International University
    • Study Director: Neven MA Sarhan, PhD, Misr International University
    • Study Director: Raed SA Ismail, PhD, Al-Azhar University in Cairo
    • Study Director: Mohamed GL El-Ansary, MD, Cairo University
    • Study Director: Mona Schaalan, PhD, Misr International University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Naglaa Samir Ahmed Bazan, Ass. Professor and Acting Head of Clinical Pharmacy Department - Cairo University Hospitals, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05157217
    Other Study ID Numbers:
    • N-134-2020
    First Posted:
    Dec 14, 2021
    Last Update Posted:
    Jul 27, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Naglaa Samir Ahmed Bazan, Ass. Professor and Acting Head of Clinical Pharmacy Department - Cairo University Hospitals, Cairo University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 27, 2022