Potential Role of Inflammasome NLRP3 And IL-1B Gene Expression in COVID-19 Patients: Impact of Ferretin and D -Dimer.
NCT ID: NCT06080750
Last Updated: 2023-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
75 participants
OBSERVATIONAL
2023-01-01
2025-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
2.3 Correlation between NLRP3, IL-1β, IL-6 and severity of the disease. 2.4 Impact of ferritin and D-dimer on inflammasome componnets NLRP3, IL-1β IL-6 .
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
International Study of Inflammation in COVID-19
NCT04818866
Gene Polymorphism of IL17 and IL 23
NCT04948515
Antibodies Responses to COVID-19 Infection in Hospitalized Patients
NCT04520880
Hematological Disorders Associated With COVID-19 Infection
NCT05677750
COVID-19 IgG Antibodies in the Serum of Recovered Patients
NCT04470414
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The first cases of COVID-19 were detected in Wuhan, China, in 2019. Since then, the illness has spread rapidly around the country and the world reaching a pandemic level (Rocklöv J et al., 2020). Cases have been reported in more than 180 countries to the World Health Organization (WHO), including more than two million deaths (WHO, 2021).
Several biochemical alterations have been described in COVID-19 patients as lymphopenia, thrombocytopenia and increased levels of C-reactive protein. The hallmark of severe COVID-19 is the cytokine storm accompanied by a hyperinflammatory response in the host due to the release of large amounts of pro-inflammatory cytokines IL-1β, IL-6, IL-2, IL-7, TNF-α, interferon-γ (IFN)-γ, CRP, procalcitonin (PCT), lactate dehydrogenase (LDH), erythrocyte sedimentation rate (ESR) and ferritin (Marcello Ciaccio and Agnello, 2020; Shah A., 2020).
The inflammasome is a multiprotein complex, known for its role in the innate immune response against viral diseases and a regulator of processing of the pro-inflammatory cytokines interleukin (IL)-1β and IL-18. Inflammasome contains a NOD-like receptor (NLR) sensor protein and pyrin domain-containing 3 , after which, NLRP3 Inflammasome was named (de Rivero Vaccari et al., 2020). The presence of inflammasome-derived products such as IL-1β, IL-18, and LDH in patients' sera suggests inflammasome engagement (Chen G et al., 2020).
Increased IL-6, IL-10, and IL-4 were found in patients when compared with controls, indicating that SARS-CoV-2 infects human monocytes and triggers NLRP3 inflammasome activation. However, the definitive demonstration of NRLP3 inflammasome participation is still required because these products can be produced via inflammasome-independent pathways (Rodrigues et al., 2021). But, the possible contribution of NLRP3 inflammasome activation and their ability to induce IL-1β production is still not clear .
The pronounced inflammatory characteristics of COVID-19 prompted us to investigate the expression of the NRLP3 inflammasome and its relation to IL-1B in disease development and severity and to determine the best anti-inflammatory will be used in COVID-19.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
healthy
as a control group
Quantitative Real Time Polymerase chain reaction (qRT-PCR)
to study gene expression of NLRP3 inflammasome and IL-1B in blood
ELISA and colorimeter
IL-6 and total LDH
mild to moderate covid-19
mild-moderate symptoms
Quantitative Real Time Polymerase chain reaction (qRT-PCR)
to study gene expression of NLRP3 inflammasome and IL-1B in blood
ELISA and colorimeter
IL-6 and total LDH
sever covid-19.
severe symptoms
Quantitative Real Time Polymerase chain reaction (qRT-PCR)
to study gene expression of NLRP3 inflammasome and IL-1B in blood
ELISA and colorimeter
IL-6 and total LDH
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Quantitative Real Time Polymerase chain reaction (qRT-PCR)
to study gene expression of NLRP3 inflammasome and IL-1B in blood
ELISA and colorimeter
IL-6 and total LDH
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Suspected of covid19 because of the presence of symptoms suggestive of pneumonia (fever\>38) and at least one of the following symptoms ;cough, dyspnea, tachpnea or hypoxia
* having RT-PCR (confirmed positive PCR)
* Chest CT within 5 days of initial PCR
Exclusion Criteria
* Cancer patients (affect result of study as they have disrubted level of these biomarker)
18 Years
90 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assiut University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Tasneem Abdel-Baset Ahmed Aly
Pharmacist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ayat A Sayed, M.D
Role: STUDY_DIRECTOR
associate professor
Mona A AlBaz, M.D
Role: STUDY_CHAIR
Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Biochemistry department,Faculty of medicine
Asyut, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Abdelmaksoud AA, Ghweil AA, Hassan MH, Rashad A, Khodeary A, Aref ZF, Sayed MAA, Elsamman MK, Bazeed SES. Olfactory Disturbances as Presenting Manifestation Among Egyptian Patients with COVID-19: Possible Role of Zinc. Biol Trace Elem Res. 2021 Nov;199(11):4101-4108. doi: 10.1007/s12011-020-02546-5. Epub 2021 Jan 7.
Chen G, Wu D, Guo W, Cao Y, Huang D, Wang H, Wang T, Zhang X, Chen H, Yu H, Zhang X, Zhang M, Wu S, Song J, Chen T, Han M, Li S, Luo X, Zhao J, Ning Q. Clinical and immunological features of severe and moderate coronavirus disease 2019. J Clin Invest. 2020 May 1;130(5):2620-2629. doi: 10.1172/JCI137244.
de Rivero Vaccari JC, Dietrich WD, Keane RW, de Rivero Vaccari JP. The Inflammasome in Times of COVID-19. Front Immunol. 2020 Oct 8;11:583373. doi: 10.3389/fimmu.2020.583373. eCollection 2020.
Ciaccio M, Agnello L. Biochemical biomarkers alterations in Coronavirus Disease 2019 (COVID-19). Diagnosis (Berl). 2020 Nov 18;7(4):365-372. doi: 10.1515/dx-2020-0057.
Rocklov J, Sjodin H, Wilder-Smith A. COVID-19 outbreak on the Diamond Princess cruise ship: estimating the epidemic potential and effectiveness of public health countermeasures. J Travel Med. 2020 May 18;27(3):taaa030. doi: 10.1093/jtm/taaa030.
Rodrigues TS, de Sa KSG, Ishimoto AY, Becerra A, Oliveira S, Almeida L, Goncalves AV, Perucello DB, Andrade WA, Castro R, Veras FP, Toller-Kawahisa JE, Nascimento DC, de Lima MHF, Silva CMS, Caetite DB, Martins RB, Castro IA, Pontelli MC, de Barros FC, do Amaral NB, Giannini MC, Bonjorno LP, Lopes MIF, Santana RC, Vilar FC, Auxiliadora-Martins M, Luppino-Assad R, de Almeida SCL, de Oliveira FR, Batah SS, Siyuan L, Benatti MN, Cunha TM, Alves-Filho JC, Cunha FQ, Cunha LD, Frantz FG, Kohlsdorf T, Fabro AT, Arruda E, de Oliveira RDR, Louzada-Junior P, Zamboni DS. Inflammasomes are activated in response to SARS-CoV-2 infection and are associated with COVID-19 severity in patients. J Exp Med. 2021 Mar 1;218(3):e20201707. doi: 10.1084/jem.20201707.
Shah A. Novel Coronavirus-Induced NLRP3 Inflammasome Activation: A Potential Drug Target in the Treatment of COVID-19. Front Immunol. 2020 May 19;11:1021. doi: 10.3389/fimmu.2020.01021. eCollection 2020. No abstract available.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NLRP3 & IL-1B in covid19
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.