Immunogenetics Predictors With COVID-19
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|ClinicalTrials.gov Identifier: NCT04390269|
Recruitment Status : Not yet recruiting
First Posted : May 15, 2020
Last Update Posted : September 2, 2020
|Condition or disease|
|Genetic Predisposition to Disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|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|
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 .
normal control subject
- 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
- Routine diagnostic analysis Routine Laboratory testing includes complete blood picture (CBC), C-reactive protein (CRP), liver function tests, Blood sugar, serum creatinine
- Routine molecular diagnostic analysis Routine molecular Laboratory testing includes Real-time PCR Detection for SARS-COV 2
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT04390269
|Contact: Mahmoud El-Bendary, M.Dfirstname.lastname@example.org|
|Mansoura Faculty of Medicine|
|Mansoura, Dakahlyia, Egypt, 35516|
|Contact: Mahmoud El-Bendary, M.D 00201002592205 email@example.com|
|Principal Investigator:||Mahmoud El-Bendary, M.D||Mansoura University|