CClinicalTrials.gg
Status unknownNCT04390269Updated Feb 24, 2021

Immunogenetics Predictors With COVID-19

An observational study in Genetic Predisposition to Disease, sponsored by Mansoura University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-24.

Sponsored by Mansoura University · Observational

The sponsor has not verified this record recently (last verified May 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Genetic Predisposition to Disease

Keywords

  • COVID-19
  • CYTOKINES
  • CHEMOKINES
  • GENETIC POLYMORPHISM
  • Immunity
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 200 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

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What researchers measure

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).

    Time frame: 2 years

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Study locations

1 of 1 sites recruiting
  • Mansoura Faculty of Medicine
    Mansoura, Dakahlyia 35516, Egypt
    Recruiting
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References and documents

Publications

  • 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. PubMed 31986261 ↗
  • 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. PubMed 32061335 ↗
  • 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. PubMed 32066525 ↗
  • 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. PubMed 32203186 ↗
  • 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. PubMed 32216893 ↗
  • 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. PubMed 32273135 ↗
  • 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. PubMed 32140732 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04390269
Lead sponsor
Mansoura University
Responsible party
Mahmoud Elbendary (Professor of Tropical Medicine and Hepatogastroenterology, Mansoura University) — Principal investigator
First posted
May 15, 2020
Start date
Sep 10, 2020
Primary completion
Oct 10, 2021 (estimated)
Completion
May 9, 2022 (estimated)
Last update
Feb 24, 2021

Study contacts

Mahmoud El-Bendary, M.D
Contact
mmelbendary@gmail.com
00201002592205
Mahmoud El-Bendary, M.D
principal investigator · Mansoura University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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