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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04462120
Other study ID # AssiutU15
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 16, 2020
Est. completion date July 30, 2020

Study information

Verified date July 2020
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date July 30, 2020
Est. primary completion date June 18, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Assiut University Hospitals Assiut
Egypt AssiutU Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measure level of polymorphisms of interleukin (IL)-12 receptor B1 (IL-12RB1) and TNF- a alpha on COVID-19 related severe acute respiratory syndrome (SARS-CoV-2). genetic polymorphism day 1
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