Impact of the Genetic Polymorphism on COVID-19 in Egypt

NCT05157217 | Unknown

• 1 other identifier: N-134-2020
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

COVID-19; Genetic Polymorphism; Pharmacogenetics

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead
• Misr International University: collaborator

Study Sites (1)

Cairo University Hospitals

Cairo, 11562, Egypt

RECRUITING

Related Publications (5)

• 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.

  PMID: 32142651 RESULT

• 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.

  PMID: 32735889 RESULT

• 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.

  PMID: 32501810 RESULT

• 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.

  PMID: 32664879 RESULT

• 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.

  PMID: 15381116 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

A baseline blood sample 3 ml on EDTA tube for genotyping of the studied alleles

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Naglaa S Bazan, PhD

  Cairo University

  PRINCIPAL INVESTIGATOR

• Khaled Farouk, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

• Adel RA Abdallah, PhD

  Al-Azhar University in Cairo

  STUDY CHAIR

• Abdelrahman A Abdelgawad, BScPharm

  Misr International University

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Central Study Contacts

Naglaa S Bazan, PhD

CONTACT

01005807504; naglaabazan@cu.edu.eg

Abdelrahman A Abdelgawad, BScPharm

CONTACT

01119110322; abdelrahman114549@miuegypt.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Professor and Acting Head of Clinical Pharmacy Department - Cairo University Hospitals

Study Record Dates

• First Submitted: December 11, 2021
• First Posted: December 14, 2021
• Study Start: December 15, 2021
• Primary Completion: August 15, 2022
• Study Completion: September 15, 2022
• Last Updated: July 27, 2022

Record last verified: 2022-07

Locations

EG (1)