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Immunogenetics Predictors With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04390269
Recruitment Status : Not yet recruiting
First Posted : May 15, 2020
Last Update Posted : September 2, 2020
Information provided by (Responsible Party):
Mahmoud Elbendary, Mansoura University

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.

Condition or disease
Genetic Predisposition to Disease

Detailed Description:

There is a current worldwide outbreak of the novel coronavirus Covid-19 (coronavirus disease 2019; the pathogen called SARS-CoV-2; previously 2019-nCoV), which originated from Wuhan in China and has now spread to 6 continents including 210 countries. Coronaviruses (CoVs), is a large family of single-stranded RNA viruses, can infect animals and humans, causing respiratory, gastrointestinal, hepatic, and neurologic diseases. Coronaviruses are a group of enveloped viruses with a positive-sense single-stranded RNA genome (26-39 kb). Four coronavirus genera (α, β, γ, δ) have been determined so far, with human coronaviruses (HCoVs) detected in the α coronavirus (HCoV-229E and NL63) and β coronavirus (e.g MERS-CoV and SARS-CoV) genera. This isolated novel β-CoV shows less than 80% similarity to the sequence of two bat-derived severe acute respiratory syndromes (SARS)-like coronaviruses, bat-SL-CoVZC45 and bat-SL-CoVZXC21, and about 50% identity to the sequence of a middle east respiratory syndrome (MERS-CoV). Patients with COVID-19 show general clinical manifestations including fever, dry cough, dyspnea, myalgia, fatigue, normal or decreased leukocyte counts, and radiographic evidence of pneumonia. After the virus enters the host cells, the viral RNA genome is released into the cytoplasm and is translated into two polyproteins and structural proteins, after which the viral genome begins to replicate. When the virus enters the host cells, its antigen will be presented to the antigen presentation cells(APC), which is a central part of the body's anti-viral immunity. Antigenic peptides are presented by major histocompatibility complex (MHC; or human leukocyte antigen (HLA) in humans) and then recognized by virus-specific cytotoxic T lymphocytes (CTLs). Hence, the understanding of the antigen presentation of SARS-CoV-2 will help our comprehension of COVID-19 pathogenesis. However, there is still a lack of any report about SARS-CoV-2, we can get a lot of information from previous researches on SARS-CoV and MERS-CoV. The antigen presentation of SARS-CoV mainly depends on MHC I molecules, but MHC II also contributes to its presentation.

These findings may provide valuable information for the rational design of vaccines against SARS-CoV-2. One of the main mechanisms for ARDS is the cytokine storm, the deadly uncontrolled systemic inflammatory response resulting from the release of huge amounts of pro-inflammatory cytokines and chemokines by immune effector cells in SARS-CoV infection. Better survive in host cells, SARS-CoV and MERS-CoV use multiple strategies to avoid immune responses. The evolutionarily conserved microbial structures called pathogen-associated molecular patterns can be recognized by pattern recognition receptors (PRR).

The antigen presentation can also be affected by the coronavirus. For example, gene expression related to antigen presentation is down-regulated after MERS-CoV infection. Therefore, destroying the immune evasion of SARS-CoV-2 is imperative in its treatment and specific drug development.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Various Molecular Markers With Predictive and Prognostic Significance in COVID-19 Outcome
Estimated Study Start Date : September 10, 2020
Estimated Primary Completion Date : October 10, 2020
Estimated Study Completion Date : May 9, 2022

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

Primary Outcome Measures :
  1. for the patients [ Time Frame: 2 years ]
    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).

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04390269

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Contact: Mahmoud El-Bendary, M.D 00201002592205

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Mansoura Faculty of Medicine
Mansoura, Dakahlyia, Egypt, 35516
Contact: Mahmoud El-Bendary, M.D    00201002592205   
Sponsors and Collaborators
Mansoura University
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Principal Investigator: Mahmoud El-Bendary, M.D Mansoura University

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Responsible Party: Mahmoud Elbendary, Professor of Tropical Medicine and Hepatogastroenterology, Mansoura University Identifier: NCT04390269    
Other Study ID Numbers: R.20.05.830.R1
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahmoud Elbendary, Mansoura University:
Additional relevant MeSH terms:
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Disease Susceptibility
Genetic Predisposition to Disease
Disease Attributes
Pathologic Processes