IL-12RB and TNF-alpha Gene Polymorphism and Susceptibility and Progress of Covid-19 SARS-CoV-2: A Case Control Study

July 7, 2020 updated by: Aliae AR Mohamed Hussein, Assiut University

Association Between IL-12RB and TNF-alpha Gene Polymorphism With Susceptibility and Progress of Covid-19 SARS-CoV-2: A Case Control Study

A novel coronavirus was identified in late 2019 in Wuhan, China On 11 February, The International Committee on Taxonomy of Viruses (ICTV) announced that the official classification of the new coronavirus (2019-nCoV) is called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The World Health Organization (WHO) announced on the same day that the official name of the disease caused by the virus is Corona Virus Disease-19 (COVID-19). WHO has declared the infection a Pandemic on March 11, 2020. Based on previous studies on SARS in 2003 and SARS-MERS 2013 there was a genetic polymorphism associated with the susceptibility and severity of the disease.

Interleukin-12 (IL-12) is a cytokine secreted by activated phagocytes and dendritic cells. It plays a pivotal role in promoting Th1-type immune responses and cell-mediated immunity. IL-12 triggers many biological functions: it stimulates the proliferation of activated T- and NK-cells, enhances T- and NK-cell-mediated cytolytic activity, and induces the production of IFN-γ by both T-and NK-cells. The interferon-γ production induced by IL-12 forms a major link between innate and adaptive immunity. A recent study revealed that interferon-mediated immunopathological events are associated with atypical innate and adaptive immune responses in SARS patients.

Also, TNF-α is a key mediator of the inflammatory response and is critical for host defense against a wide variety of pathogenic microbes. However, the over-expression of this cytokine may lead to badness in disease recovery. The dual role of TNF, acting as an agent of both innate immunity and inflammatory pathology, poses a considerable challenge for gene regulation.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Assiut university hospitals
      • Assiut, Egypt, 71111
        • AssiutU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with confirmed COVID-19 PCR ( mild, moderate and severe cases) admitted to wards or ICU Assiut University Hospitals

Description

Inclusion Criteria:

  • Patients with confirmed COVID-19 PCR ( mild, moderate and severe cases) admitted to wards or ICU Assiut University Hospitals

Exclusion Criteria:

  • Suspected or non confirmed cases of COVID-19

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure level of polymorphisms of interleukin (IL)-12 receptor B1 (IL-12RB1) and TNF- α alpha on COVID-19 related severe acute respiratory syndrome (SARS-CoV-2).
Time Frame: day 1
genetic polymorphism
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2020

Primary Completion (Actual)

June 18, 2020

Study Completion (Anticipated)

July 30, 2020

Study Registration Dates

First Submitted

June 19, 2020

First Submitted That Met QC Criteria

July 7, 2020

First Posted (Actual)

July 8, 2020

Study Record Updates

Last Update Posted (Actual)

July 8, 2020

Last Update Submitted That Met QC Criteria

July 7, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AssiutU15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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