Potential Role of Inflammasome NLRP3 And IL-1B Gene Expression in COVID-19 Patients: Impact of Ferretin and D -Dimer.

October 10, 2023 updated by: Tasneem Abdel-Baset Ahmed Aly, Assiut University

Potential Role of Inflammasome NLRP3 And IL-1B Gene Expression In COVID-19 Patients: Impact of Ferretin and D -Dimer.

2.1 Study the role of NLRP3 inflammasome in COVID-19 patients. 2.2 Study the gene expression of NLRP3 and IL-1β in blood samples of COVID-19 patients and compare to apparently healthy subjects.

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 .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a viral infection that results in respiratory disease, which can evolve into multiorgan failure (MOF), leading to death (Aida A Abdelmaksoud et al., 2021).

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.

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt
        • Recruiting
        • Biochemistry department,Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Covid 19 patients andcontrol

Description

Inclusion Criteria:

  • Adult Patient aged 18years and over presented to Assiut University Hospital
  • 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:

  • Cases less than 18 years old
  • Cancer patients (affect result of study as they have disrubted level of these biomarker)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
healthy
as a control group
Genetic: Quantitative Real Time Polymerase chain reaction (qRT-PCR)
to study gene expression of NLRP3 inflammasome and IL-1B in blood
Other Names:
  • qRT-PCR
Diagnostic test: ELISA and colorimeter
IL-6 and total LDH
mild to moderate covid-19
mild-moderate symptoms
Genetic: Quantitative Real Time Polymerase chain reaction (qRT-PCR)
to study gene expression of NLRP3 inflammasome and IL-1B in blood
Other Names:
  • qRT-PCR
Diagnostic test: ELISA and colorimeter
IL-6 and total LDH
sever covid-19.
severe symptoms
Genetic: Quantitative Real Time Polymerase chain reaction (qRT-PCR)
to study gene expression of NLRP3 inflammasome and IL-1B in blood
Other Names:
  • qRT-PCR
Diagnostic test: ELISA and colorimeter
IL-6 and total LDH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gene expression of NLRP3, IL-1β and level IL-6
Time Frame: 3 years
Fold change increased in gene expression of NLRP3, IL-1β and level IL-6 and severity of the disease
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ferritin and D-dimer on NLRP3, IL-1β and IL-6
Time Frame: 3 years
The relation between level of ferritin and D-dimer on NLRP3, IL-1β and IL-6
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Ayat A Sayed, M.D, Associate Professor
  • Study Chair: Mona A AlBaz, M.D, Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

October 10, 2023

First Submitted That Met QC Criteria

October 10, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 10, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NLRP3 & IL-1B in covid19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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