Multisystem Inflammatory Syndrome in ChildrenNCT05382234
Multisystem Inflammatory Syndrome In Children at Sohag University Hospital
An observational study of Multisystem Inflammatory Syndrome in Children, run by Sohag University at 1 site in Egypt.
Trial summary
Since its initial description in December 2019 in Wuhan , China, Corona virus disease 2019 (COVID-19), caused by infection with severe acute respiratory syndrome corona virus 2 (SARS-CoV-2), has rapidly evolved into a worldwide pandemic affecting millions of lives . Read more about this study
- Who is it for?
- Ages 1 day to 12 years
- Conditions the study is for
- Multisystem Inflammatory Syndrome in Children
- What is being tested?
- CBC, ESR ,CRP,Liver Function ,renal function ,ABG,Na,K,D-dimmer ,cardiac enzyme,ferritin ,blood and urine culture in negative cases
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 1 Jun 2023
- 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 1 day to 12 years
- All sexes
- Child
Study population: Multisystem inflammatory syndrome in children
Who may be able to join
- Any suspected case of MIS-C from birth to 12 year included both sexes fulfill criteria of MIS-C (WHO) .
- Fever for ≥3 days.
- Clinical signs of multi system involvement (at least 2 of the following):
- Rash, bilateral non purulent conjunctivitis, or mucocutaneou inflammation signs (oral, hands, or feet)
- Hypotension or shock
- Cardiac dysfunction, pericarditis, valvulitis , or coronary abnormalities (including echocardiographic findings or elevated troponin)
Show all 10Show fewer
- Evidence of coagulopathy (prolonged PT or PTT)
- Acute gastrointestinal symptoms (diarrhea , vomiting, or abdominal pain)
- 4. Elevated markers of inflammation (eg ESR, CRP) 5. No other obvious microbial cause of inflammation. 6. Evidence of SARS-CoV-2 infection (Any of the following: Positive SARS-CoV-2 RT-PCR ,positive serology, COVID 19 exposure within the 4 weeks prior to the onset of symptoms).
- according to CDC criteria exposure to a patients with suspected or confirmed COVID-19 within the 4 weeks prior to the onset of symptoms.
Who cannot join
- Other obvious microbial cause of inflammation, including bacterial sepsis and staphylococcal/streptococcal toxic shock syndromes.
Trial locations and contacts
1 site in 1 country.
Osama R Elsherief, Professor contact
About this study
Since its initial description in December 2019 in Wuhan , China, Corona virus disease 2019 (COVID-19), caused by infection with severe acute respiratory syndrome corona virus 2 (SARS-CoV-2), has rapidly evolved into a worldwide pandemic affecting millions of lives .
Unlike adults, the vast majority of children with COVID-19 have mild symptoms. However, there are children who have significant respiratory disease, and some children may develop a hyper inflammatory response similar to what has been observed in adults with COVID-19. Furthermore, in late April 2020, reports emerged of children with a different clinical syndrome resembling Kawasaki disease (KD) and toxic shock syndrome; these patients frequently had evidence of prior exposure to SARS-CoV-2.
Read more
The pathophysiology of MIS-C:
Is unclear ,but it appears to be a consequence of a exacerbated immune system response or maladaptive response of the host .After the virus enters the human cells, the first line of defense against infection should be a quick and well-coordinated immune response ;however, when this mechanism is unregulated and excessive ,hyper inflammation can occur.
Cytokines that play an important role in inducing immunity and immunopathology during infections in excess can cause the clinical syndrome known as cytokine storm. The inflammatory response caused by SARS-CoV-2appears to be the major cause of mortality in infected patients .
The infection of dendritic cells or macrophages by SARS-CoV-2 induces the production of low levels of antiviral cytokines and increases the production of inflammatory cytokines (tumor necrosis factor[TNF], interleukin[IL]-1, IL-6,and interferon ).
- Being tested
- CBC, ESR ,CRP,Liver Function ,renal function ,ABG,Na,K,D-dimmer ,cardiac enzyme,ferritin ,blood and urine culture in negative cases
- Medical subject headings
- pediatric multisystem inflammatory disease, COVID-19 related
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBC, ESR ,CRP,Liver Function ,renal function ,ABG,Na,K,D-dimmer ,cardiac enzyme,ferritin ,blood and urine culture in negative casesDiagnostic test
cllinical and laboratory evaluation of MIS-C,Effectivness of different therapeutic modalities,Outcome of cases (morbidity,mortality)
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed or suspected cases of Multisystem inflammatory syndrome in children
Confirmed or suspected cases Multisystem inflammatory syndrome in children based On WHO Criteria of MIS-C
- Age 0-19 years.
- Fever for ≥3 days.
- Clinical signs of multi system involvement (at least 2 of the following):
- Rash, bilateral non purulent conjunctivitis, or mucocutaneous inflammation signs
- Hypotension or shock
- Evidence of coagulopathy (prolonged PT or PTT)
- Acute gastrointestinal symptoms (diarrhea , vomiting, or abdominal pain)
- Elevated markers of inflammation (eg ESR, CRP)
- No other obvious microbial cause of inflammation.
- Evidence of SARS-CoV-2 infection (Any of the following: Positive SARS-CoV-2 RT-PCR ,positive serology, COVID 19 exposure within the 4 weeks prior to the onset of symptoms). according to CDC criteria exposure to a patients with suspected or confirmed COVID-19 within the 4 weeks prior to the onset of symptoms.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multisystem Inflammatory Syndrome in ChildrenStudies of the same condition, open and under way.
- More trials run by Sohag 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youstena Rashed Attia, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382234
- Sponsor's protocol ID
- Soh-Med-22-05-12
- Status last verified
- May 2022
- First submitted
- 15 May 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dong E, Du H, Gardner L. An interactive web-based dashboard to track COVID-19 in real time. Lancet Infect Dis. 2020 May;20(5):533-534. doi: 10.1016/S1473-3099(20)30120-1. Epub 2020 Feb 19. No abstract available.
PubMed 32087114Riphagen S, Gomez X, Gonzalez-Martinez C, Wilkinson N, Theocharis P. Hyperinflammatory shock in children during COVID-19 pandemic. Lancet. 2020 May 23;395(10237):1607-1608. doi: 10.1016/S0140-6736(20)31094-1. Epub 2020 May 7. No abstract available.
PubMed 32386565Alunno A, Carubbi F, Rodriguez-Carrio J. Storm, typhoon, cyclone or hurricane in patients with COVID-19? Beware of the same storm that has a different origin. RMD Open. 2020 May;6(1):e001295. doi: 10.1136/rmdopen-2020-001295.
PubMed 32423970Channappanavar R, Perlman S. Pathogenic human coronavirus infections: causes and consequences of cytokine storm and immunopathology. Semin Immunopathol. 2017 Jul;39(5):529-539. doi: 10.1007/s00281-017-0629-x. Epub 2017 May 2.
PubMed 28466096
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multisystem Inflammatory Syndrome In Children at Sohag University Hospital
- ClinicalTrials.gov ID
- NCT05382234
- Acronym / sponsor ID
- Soh-Med-22-05-12
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 19 May 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.
Since its initial description in December 2019 in Wuhan , China, Corona virus disease 2019 (COVID-19), caused by infection with severe acute respiratory syndrome corona virus 2 (SARS-CoV-2), has rapidly evolved into a worldwide pandemic affecting millions of lives .
Unlike adults, the vast majority of children with COVID-19 have mild symptoms. However, there are children who have significant respiratory disease, and some children may develop a hyper inflammatory response similar to what has been observed in adults with COVID-19. Furthermore, in late April 2020, reports emerged of children with a different clinical syndrome resembling Kawasaki disease (KD) and toxic shock syndrome; these patients frequently had evidence of prior exposure to SARS-CoV-2.
The pathophysiology of MIS-C:
Is unclear ,but it appears to be a consequence of a exacerbated immune system response or maladaptive response of the host .After the virus enters the human cells, the first line of defense against infection should be a quick and well-coordinated immune response ;however, when this mechanism is unregulated and excessive ,hyper inflammation can occur.
Cytokines that play an important role in inducing immunity and immunopathology during infections in excess can cause the clinical syndrome known as cytokine storm. The inflammatory response caused by SARS-CoV-2appears to be the major cause of mortality in infected patients .
The infection of dendritic cells or macrophages by SARS-CoV-2 induces the production of low levels of antiviral cytokines and increases the production of inflammatory cytokines (tumor necrosis factor[TNF], interleukin[IL]-1, IL-6,and interferon ).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 day to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- Multisystem inflammatory syndrome in children
Key inclusion criteria (10 listed)
- Any suspected case of MIS-C from birth to 12 year included both sexes fulfill criteria of MIS-C (WHO) .
- Fever for ≥3 days.
- Clinical signs of multi system involvement (at least 2 of the following):
- 4. Elevated markers of inflammation (eg ESR, CRP) 5. No other obvious microbial cause of inflammation. 6. Evidence of SARS-CoV-2 infection (Any of the following: Positive SARS-CoV-2 RT-PCR ,positive serology, COVID 19 exposure within the 4 weeks prior to the onset of symptoms).
- according to CDC criteria exposure to a patients with suspected or confirmed COVID-19 within the 4 weeks prior to the onset of symptoms.
Key exclusion criteria (1 listed)
- Other obvious microbial cause of inflammation, including bacterial sepsis and staphylococcal/streptococcal toxic shock syndromes.
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 |
|---|---|---|
| CBC, ESR ,CRP,Liver Function ,renal function ,ABG,Na,K,D-dimmer ,cardiac enzyme,ferritin ,blood and urine culture in negative casescllinical and laboratory evaluation of MIS-C,Effectivness of different therapeutic modalities,Outcome of cases (morbidity,mortality) | Diagnostic test | – |
Primary outcome
Confirmed or suspected cases of Multisystem inflammatory syndrome in children
Time frame: 1 year
Confirmed or suspected cases Multisystem inflammatory syndrome in children based On WHO Criteria of MIS-C 1. Age 0-19 years. 2. Fever for ≥3 days. 3. Clinical signs of multi system involvement (at least 2 of the following): 1. Rash, bilateral non purulent conjunctivitis, or mucocutaneous inflammation signs 2. Hypotension or shock 3. Evidence of coagulopathy (prolonged PT or PTT) 4. Acute gastrointestinal symptoms (diarrhea , vomiting, or abdominal pain) 4. Elevated markers of inflammation (eg ESR, CRP) 5. No other obvious microbial cause of inflammation. 6. Evidence of SARS-CoV-2 infection (Any of the following: Positive SARS-CoV-2 RT-PCR ,positive serology, COVID 19 exposure within the 4 weeks prior to the onset of symptoms). according to CDC criteria exposure to a patients with suspected or confirmed COVID-19 within the 4 weeks prior to the onset of symptoms.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Background: PubMed 32087114Dong E, Du H, Gardner L. An interactive web-based dashboard to track COVID-19 in real time. Lancet Infect Dis. 2020 May;20(5):533-534. doi: 10.1016/S1473-3099(20)30120-1. Epub 2020 Feb 19. No abstract available.
- Background: PubMed 32386565Riphagen S, Gomez X, Gonzalez-Martinez C, Wilkinson N, Theocharis P. Hyperinflammatory shock in children during COVID-19 pandemic. Lancet. 2020 May 23;395(10237):1607-1608. doi: 10.1016/S0140-6736(20)31094-1. Epub 2020 May 7. No abstract available.
- Background: PubMed 32423970Alunno A, Carubbi F, Rodriguez-Carrio J. Storm, typhoon, cyclone or hurricane in patients with COVID-19? Beware of the same storm that has a different origin. RMD Open. 2020 May;6(1):e001295. doi: 10.1136/rmdopen-2020-001295.
- Background: PubMed 28466096Channappanavar R, Perlman S. Pathogenic human coronavirus infections: causes and consequences of cytokine storm and immunopathology. Semin Immunopathol. 2017 Jul;39(5):529-539. doi: 10.1007/s00281-017-0629-x. Epub 2017 May 2.
- Individual participant dataSharing planned: Undecided
Related trials for Multisystem Inflammatory Syndrome in Children
RecruitingObservational study
Genetic Basis of SARS-CoV-2 Infection-Associated Multisystem Inflammatory Syndrome in Children (MIS-C)
MIS-C Associated With COVID-19
RecruitingObservational study
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension
RecruitingObservational study
Cardiovascular Assessment 5 Years After MIS-C
Multisystem Inflammatory Syndrome in Children (MIS-C), SARS-CoV-2 Infection
Active, not recruitingPhase 4
A Study to Learn About The COVID-19 (Study) Vaccine (Called COMIRNATY) in People That Are Less Than 21 Years Old.
Myocarditis
Active, not recruitingObservational study
Long-Term Outcomes After the Multisystem Inflammatory Syndrome in Children
Multisystem Inflammatory Syndrome in Children (MIS-C)
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.
Osama R Elsherief, Professor contact
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 Multisystem Inflammatory Syndrome in Children, run by Sohag 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 10 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 19 May 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 Youstina R Attia, residant (01275866826, youstinarashed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmed or suspected cases of Multisystem inflammatory syndrome in children (time frame: 1 year). 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 NCT05382234, which also lists 4 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 19 May 2022.