Immunogenetics Predictors With COVID-19

NCT04390269 | Unknown

• 1 other identifier: R.20.05.830.R1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Background: There is a current worldwide outbreak of the novel coronavirus Covid-19 which originated from Wuhan in China and has now spread to 6 continents including 210 countries. There is still a lack of any report about severe acute respiratory syndromes (SARS-CoV-2) genetic polymorphisms which are associated with the susceptibility to infection. In addition, gene polymorphisms of MBL (mannose-binding lectin) associated with antigen presentation are related to the risk of SARS-CoV infection. Aim: To investigate the association of different genetic markers of different mechanisms of viral pathogenesis with the outcome of COVID-19. Methods: The study will include one hundred patients diagnosed as COVID-19. Biological blood samples will be taken for routine diagnostic analysis, routine molecular testing using Real-time polymerase chain reaction (PCR), Allelic discrimination and genotyping analysis. Outcome: Different genetic markers could play a role in the outcome and prognosis of COVID-19 viral infection.

Conditions

Genetic Predisposition to Disease

Keywords

COVID-19; CYTOKINES; CHEMOKINES; GENETIC POLYMORPHISM; Immunity

Outcome Measures

Primary Outcomes (1)

• for the patients

  To assess genetic mutation via detection of genetic polymorphisms of ACE2 in patients and control to detect what alleles will be associated with the susceptibility to COVID-19 and what alleles will be associated with clearance or protection from infections. using allelic discrimination SSCP (i.e Real-time PCR and genetic sequencer).

  2 years

Study Arms (3)

Infected group

The infected group will be classified according to the severity whether mild ,moderate or severe

susceptible (non infected

This group either exposed and not infected .

control group

normal control subject

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

They will evaluate the clinical usefulness of the application of different diagnostic tests, monitoring tools and therapeutic options in clinical practice to improve the disease outcomes and reduce the costs of the disease burdens. In brief, the approach will consist of the following steps: 1. Early diagnosis of patients at risk of COVID 19 evolution and their surveillance and monitoring by different means. 2. Specific laboratory analysis for different genetic molecular tests for COVID 19 infection. 3. Monitoring the genetic molecular tests in the follow-up periods.

You may qualify if:

• Adult subjects (\> 18 years old) with COVID 19 infection.The patients will be classified on the basis of the severity of the disease.

You may not qualify if:

• patients have symptoms of fever and /or respiratory with negative PCR for COVID-19.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura Faculty of Medicine

Al Mansurah, Dakahlyia, 35516, Egypt

RECRUITING

Related Publications (7)

• Chan JF, Yuan S, Kok KH, To KK, Chu H, Yang J, Xing F, Liu J, Yip CC, Poon RW, Tsoi HW, Lo SK, Chan KH, Poon VK, Chan WM, Ip JD, Cai JP, Cheng VC, Chen H, Hui CK, Yuen KY. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet. 2020 Feb 15;395(10223):514-523. doi: 10.1016/S0140-6736(20)30154-9. Epub 2020 Jan 24.

  PMID: 31986261 BACKGROUND

• Zhang J, Zhou L, Yang Y, Peng W, Wang W, Chen X. Therapeutic and triage strategies for 2019 novel coronavirus disease in fever clinics. Lancet Respir Med. 2020 Mar;8(3):e11-e12. doi: 10.1016/S2213-2600(20)30071-0. Epub 2020 Feb 13. No abstract available.

  PMID: 32061335 BACKGROUND

• Xu Z, Li S, Tian S, Li H, Kong LQ. Full spectrum of COVID-19 severity still being depicted. Lancet. 2020 Mar 21;395(10228):947-948. doi: 10.1016/S0140-6736(20)30308-1. Epub 2020 Feb 14. No abstract available.

  PMID: 32066525 BACKGROUND

• Zheng HY, Zhang M, Yang CX, Zhang N, Wang XC, Yang XP, Dong XQ, Zheng YT. Elevated exhaustion levels and reduced functional diversity of T cells in peripheral blood may predict severe progression in COVID-19 patients. Cell Mol Immunol. 2020 May;17(5):541-543. doi: 10.1038/s41423-020-0401-3. Epub 2020 Mar 17. No abstract available.

  PMID: 32203186 BACKGROUND

• Lu KL, Chen S, Leung LP. Initial Experience of an Emergency Department in Shenzhen in Responding to the Emerging Wuhan Coronavirus Pneumonia. Ann Emerg Med. 2020 Apr;75(4):556. doi: 10.1016/j.annemergmed.2020.02.006. No abstract available.

  PMID: 32216893 BACKGROUND

• Hu Y, Deng H, Huang L, Xia L, Zhou X. Analysis of Characteristics in Death Patients with COVID-19 Pneumonia without Underlying Diseases. Acad Radiol. 2020 May;27(5):752. doi: 10.1016/j.acra.2020.03.023. Epub 2020 Apr 7. No abstract available.

  PMID: 32273135 BACKGROUND

• Chen C, Zhou Y, Wang DW. SARS-CoV-2: a potential novel etiology of fulminant myocarditis. Herz. 2020 May;45(3):230-232. doi: 10.1007/s00059-020-04909-z. No abstract available.

  PMID: 32140732 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Biological sample will take for the following analysis 1. Routine diagnostic analysis Routine Laboratory testing includes complete blood picture (CBC), C-reactive protein (CRP), liver function tests, Blood sugar, serum creatinine 2. Routine molecular diagnostic analysis Routine molecular Laboratory testing includes Real-time PCR Detection for SARS-COV 2 3. Laboratory investigation for candidate gene i. Nucleic Acid Extraction from peripheral blood: the first step will include High-quality total nucleic acid extraction covering DNA, RNA, non-coding RNA, and Micro RNA ii. Allelic discrimination using ABI 7500 real-time PCR. The host DNA will be genotyped for candidate genes using TaqMan® SNP genotyping assays

MeSH Terms

Conditions

Genetic Predisposition to Disease; COVID-19

Condition Hierarchy (Ancestors)

Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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

• Mahmoud El-Bendary, M.D

  Mansoura University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahmoud El-Bendary, M.D

CONTACT

00201002592205; mmelbendary@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Tropical Medicine and Hepatogastroenterology

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 15, 2020
• Study Start: September 10, 2020
• Primary Completion: October 10, 2021
• Study Completion: May 9, 2022
• Last Updated: February 24, 2021

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)