Inflammasome NLRP3 And IL-1B Gene Expression in COVID-19 PatientsNCT06080750
Potential Role of Inflammasome NLRP3 And IL-1B Gene Expression in COVID-19 Patients: Impact of Ferretin and D -Dimer.
An observational study of Inflammasome NLRP3 And IL-1B Gene Expression in COVID-19 Patients, run by Assiut University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammasome NLRP3 And IL-1B Gene Expression in COVID-19 Patients
- What is being tested?
- Quantitative Real Time Polymerase chain reaction (qRT-PCR) and ELISA and colorimeter
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Jan 2025
- How long will I take part?
- 5 Days
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Covid 19 patients andcontrol
Who may be able to join
- 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
Who cannot join
- Cases less than 18 years old
- Cancer patients (affect result of study as they have disrubted level of these biomarker)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Biochemistry department,Faculty of medicine
Asyut
About this study
Official title: 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 .
Read the 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.
- Being tested
- Quantitative Real Time Polymerase chain reaction (qRT-PCR), ELISA and colorimeter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative Real Time Polymerase chain reaction (qRT-PCR)Genetic
Also called qRT-PCR
to study gene expression of NLRP3 inflammasome and IL-1B in blood
ELISA and colorimeterDiagnostic test
IL-6 and total LDH
| Study group | Role | What they receive |
|---|---|---|
| healthy | as a control group Receives: Genetic: Quantitative Real Time Polymerase chain reaction (qRT-PCR); Diagnostic Test: ELISA and colorimeter | |
| mild to moderate covid-19 | mild-moderate symptoms Receives: Genetic: Quantitative Real Time Polymerase chain reaction (qRT-PCR); Diagnostic Test: ELISA and colorimeter | |
| sever covid-19. | severe symptoms Receives: Genetic: Quantitative Real Time Polymerase chain reaction (qRT-PCR); Diagnostic Test: ELISA and colorimeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
gene expression of NLRP3, IL-1β and level IL-6
Fold change increased in gene expression of NLRP3, IL-1β and level IL-6 and severity of the disease
Measured: 3 years
Secondary outcomes (1)
ferritin and D-dimer on NLRP3, IL-1β and IL-6
The relation between level of ferritin and D-dimer on NLRP3, IL-1β and IL-6
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 posted12 Oct 2023
- Study start1 Jan 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Inflammasome NLRP3 And IL-1B Gene Expression in COVID-19 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
- Cross-sectional
- Enrolment
- 75 participants (estimated)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tasneem Abdel-Baset Ahmed Aly, Assiut University
- Investigators
- Ayat A Sayed, M.D, Study director, associate professorMona A AlBaz, M.D, Study chair, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080750
- Sponsor's protocol ID
- NLRP3 & IL-1B in covid19
- Status last verified
- Oct 2023
- First submitted
- 10 Oct 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33409924Chen 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.
PubMed 32217835de 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.
PubMed 33149733Ciaccio 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.
PubMed 32589600Rocklov 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.
PubMed 32109273Rodrigues 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.
PubMed 33231615Shah 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.
PubMed 32574259
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Role of Inflammasome NLRP3 And IL-1B Gene Expression In COVID-19 Patients: Impact of Ferretin and D -Dimer.
- ClinicalTrials.gov ID
- NCT06080750
- Acronym / sponsor ID
- NLRP3 & IL-1B in covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 12 Oct 2023 (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.
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 .
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy | – | Genetic: Quantitative Real Time Polymerase chain reaction (qRT-PCR), Diagnostic Test: ELISA and colorimeteras a control group |
| mild to moderate covid-19 | – | Genetic: Quantitative Real Time Polymerase chain reaction (qRT-PCR), Diagnostic Test: ELISA and colorimetermild-moderate symptoms |
| sever covid-19. | – | Genetic: Quantitative Real Time Polymerase chain reaction (qRT-PCR), Diagnostic Test: ELISA and colorimetersevere symptoms |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Covid 19 patients andcontrol
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Cases less than 18 years old
- Cancer patients (affect result of study as they have disrubted level of these biomarker)
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 |
|---|---|---|
| Quantitative Real Time Polymerase chain reaction (qRT-PCR)Also: qRT-PCRto study gene expression of NLRP3 inflammasome and IL-1B in blood | Genetic | healthy, mild to moderate covid-19, sever covid-19. |
| ELISA and colorimeterIL-6 and total LDH | Diagnostic test | healthy, mild to moderate covid-19, sever covid-19. |
Primary outcome
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
1 secondary outcome
ferritin and D-dimer on NLRP3, IL-1β and IL-6
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Background: PubMed 33409924Abdelmaksoud 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.
- Background: PubMed 32217835Chen 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.
- Background: PubMed 33149733de 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.
- Background: PubMed 32589600Ciaccio 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.
- Background: PubMed 32109273Rocklov 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.
- Background: PubMed 33231615Rodrigues 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.
- Background: PubMed 32574259Shah 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.
- Individual participant dataSharing planned: Undecided
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.
Ayat A Sayed, M.D study director
associate professor
Mona A AlBaz, M.D study chair
Professor
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 Inflammasome NLRP3 And IL-1B Gene Expression in COVID-19 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 4 inclusion and 2 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 12 Oct 2023. 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 Tasneem A Alsanory, Master (+20106852153, tasneem.a.alsanory@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gene expression of NLRP3, IL-1β and level IL-6 (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06080750, which also lists 7 linked publications.
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 12 Oct 2023.