Beta Endorphins,Interleukin 1 and Interleukin 38 in Covid Patients Associated With Neuropsychological Manifestations.

Measurement of Beta endorphins,interleukin 1 and interleukin 38 in covid patients associated with neuropsychological manifestations.

Study Overview

• Status: Recruiting
• Conditions: Covid Patients
• Intervention / Treatment: Diagnostic test: βeta endorphins, interleukin 6 and interleukin 38

Detailed Description

The world is facing one of its worst infectious disease pandemics in history, i.e., Covid-19. Coronavirus, SARS-CoV-2 was identified as the cause of an outbreak of a severe pneumonia-like disease, currently known as Covid-19. When COVID-19 infect the upper and lower respiratory tract it can cause mild or highly acute respiratory syndrome with consequent release of pro-inflammatory cytokines, including interleukin (IL)-1β and IL-6. (Herold T., et al., 2020) Although the main risks of COVID-19 is to cause injuries to the upper and lower respiratory track and lung, other organs are also affected including CNS leading to variety of neuropsychatric symptoms including headache, depression, and memory impairment.These psychological symptoms become more obvious by quarantine which is one of the most common protections against virus infections .These psychological symptoms also aasociated with alteration of level of beta endorphins. (Long B et al.,2020).

β-Endorphin, a morphine-like peptide, was identified in brain as an endogenous opioid peptide hormone that is produced and secreted in the pituitary gland and related to pain modulation and strongly linked to chronicity and severity of depression. The specific receptor for β-endorphin is the μ-opioid receptor. (Tanaka et al., 2003) β-Endorphin stimulates chemotaxis of monocytes, their differentiation into macrophages, and production of reactive oxygen species, interleukin (IL)-1β, IL-10, interferon-γ, and tumor necrosis factor-α in monocytes/macrophages. The μ-opioid receptor is upregulated by IL-1α and IL-1β. (Gein et al.,2016) The psychological disorders caused by Covid-19 have significant effects on the immune system, resulting in mast cell activation, increased generation of cytokines like IL-1, IL-37, IL-6, and C-reactive protein. Endorphin release therapy (ERT) can be very effective to reactivate thymus gland, increase production of NK cells and CD4+ cells and inhibit CD8+cells, prevent, and reduce inflammation in Covid-19 patients, thereby reducing many complications and associated deaths. (Ahmadpoor P et al ., 2020 ) IL-38 is the newest cytokine of the IL-1 family members, produced by several immune cells including B cells and macrophages. IL-38 is a suppressor cytokine which inhibits IL-1β and other pro-inflammatory IL-family members. IL-38 is a potential therapeutic cytokine which inhibits inflammation in viral infections including that caused by coronavirus-19, providing a new relevant strategy. (Gómez-Rial J et al.,2020)

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

• Study Contact: Name: somaya redwan younes, master; Phone Number: 01099865482; Email: somayaredwanmalak@gmail.com
• Study Contact Backup: Name: Eman mosaad zaki, doctor; Phone Number: 01065518821; Email: Eman_mosaad@hotmail.com

Study Locations

• Egypt
  • Assiut, Egypt
    • Recruiting
    • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Sixity patients diagnosed with Covid-19 (30 patients with neurological manifestations and 30 patients without neurological manifestations) 30 healthy individuals as control group with matched age and sex.

Description

Inclusion Criteria: Patients had positive throat swab. Patients had chest finding on CT

Exclusion Criteria:

Other respiratory diseases

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
- Detection of βeta endorphins, interleukin 6 and interleukin 38 in serum of COVID-19 patients.	- Detection of βeta endorphins, interleukin 6 and interleukin 38 in serum of COVID-19 patients.	3 years

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): March 30, 2024
• Study Completion (Anticipated): March 30, 2024

Study Registration Dates

• First Submitted: January 19, 2022
• First Submitted That Met QC Criteria: January 19, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): January 25, 2022
• Last Update Submitted That Met QC Criteria: January 22, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Endorphins
• Other Study ID Numbers: covid study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

IPD Plan Description

- Collection of peripheral blood samples in gel tube.

• - Creparation of samples in centrifuge to obtain serum.
• - Measurement of interleukin 6 and interleukin 38 and βeta endorphins using ELISA method.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No