Covid PatientsNCT05198388
Beta Endorphins,Interleukin 1 and Interleukin 38 in Covid Patients Associated With Neuropsychological Manifestations.
An observational study of Covid Patients, run by Assiut University at 1 site in Egypt.
Trial summary
Measurement of Beta endorphins,interleukin 1 and interleukin 38 in covid patients associated with neuropsychological manifestations. Read more about this study
- Who is it for?
- Ages 2 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid Patients
- What is being tested?
- βeta endorphins, interleukin 6 and interleukin 38
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 30 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- Other respiratory diseases
Trial locations and contacts
1 site in 1 country.
About this study
Measurement of Beta endorphins,interleukin 1 and interleukin 38 in covid patients associated with neuropsychological manifestations.
Read the 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)
- Conditions
- Covid Patients
- Being tested
- βeta endorphins, interleukin 6 and interleukin 38
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
βeta endorphins, interleukin 6 and interleukin 38Diagnostic test
- - 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
- 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Mar 2023 (estimated)
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid PatientsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, somaya redwan younes, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198388
- Sponsor's protocol ID
- covid study
- Status last verified
- Jan 2022
- First submitted
- 19 Jan 2022
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: \- 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta Endorphins,Interleukin 1 and Interleukin 38 in Covid Patients Associated With Neuropsychological Manifestations.
- ClinicalTrials.gov ID
- NCT05198388
- Acronym / sponsor ID
- covid study
- Conditions
- Covid Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Other respiratory diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| βeta endorphins, interleukin 6 and interleukin 38* - 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. | Diagnostic test | – |
Primary outcome
- Detection of βeta endorphins, interleukin 6 and interleukin 38 in serum of COVID-19 patients.
Time frame: 3 years
- Detection of βeta endorphins, interleukin 6 and interleukin 38 in serum of COVID-19 patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Individual participant dataSharing planned: Undecided. - 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.
Related trials for Covid Patients
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
RecruitingPhase 3
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Viral Lung Infection and Acute Respiratory Failure
RecruitingObservational study
Physiological Finding in Management of COVID 19 Patients
COVID-19 (Coronavirus Disease 2019)
Active, not recruitingObservational study
A Study to Look at the Health Outcomes of Patients With COVID-19 and Influenza
COVID-19, Coronavirus Disease 2019
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid Patients, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact somaya redwan younes, master (01099865482, somayaredwanmalak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- Detection of βeta endorphins, interleukin 6 and interleukin 38 in serum of COVID-19 patients. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.