Clinical trial NCT05198388: Beta Endorphins,Interleukin 1 and Interleukin 38 in Covid Patients Associated With Neuropsychological Manifestations.
Official title: Beta Endorphins,Interleukin 1 and Interleukin 38 in Covid Patients Associated With Neuropsychological Manifestations.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid Patients
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 90
Sex: ALL
Minimum age (years): 2
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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

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)

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

Exclusion Criteria:

Other respiratory diseases

Primary outcomes:
measure: - Detection of βeta endorphins, interleukin 6 and interleukin 38 in serum of COVID-19 patients.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References: