Multisystem Inflammatory Syndrome In Children at Sohag University Hospital

NCT ID: NCT05382234

Last Updated: 2022-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-06-01

Brief Summary

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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 ).

Detailed Description

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Conditions

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Multisystem Inflammatory Syndrome in Children

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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CBC, ESR ,CRP,Liver Function ,renal function ,ABG,Na,K,D-dimmer ,cardiac enzyme,ferritin ,blood and urine culture in negative cases

cllinical and laboratory evaluation of MIS-C,Effectivness of different therapeutic modalities,Outcome of cases (morbidity,mortality)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Any suspected case of MIS-C from birth to 12 year included both sexes fulfill criteria of MIS-C (WHO) .

1. Fever for ≥3 days.
2. Clinical signs of multi system involvement (at least 2 of the following):

1. Rash, bilateral non purulent conjunctivitis, or mucocutaneou inflammation signs (oral, hands, or feet)
2. Hypotension or shock
3. Cardiac dysfunction, pericarditis, valvulitis , or coronary abnormalities (including echocardiographic findings or elevated troponin)
4. Evidence of coagulopathy (prolonged PT or PTT)
5. 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.

Exclusion Criteria

* Other obvious microbial cause of inflammation, including bacterial sepsis and staphylococcal/streptococcal toxic shock syndromes.
Minimum Eligible Age

1 Day

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Youstena Rashed Attia

Resident docotor pediatric department Facuity Of Medicine Sohag University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag university hospital

Sohag, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Youstina R Attia, residant

Role: CONTACT

01275866826

Osama R Elsherief, Professor

Role: CONTACT

Facility Contacts

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Osama R Elshirief, professor

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 32087114 (View on PubMed)

Riphagen 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.

Reference Type BACKGROUND
PMID: 32386565 (View on PubMed)

Alunno 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.

Reference Type BACKGROUND
PMID: 32423970 (View on PubMed)

Channappanavar 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.

Reference Type BACKGROUND
PMID: 28466096 (View on PubMed)

Other Identifiers

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Soh-Med-22-05-12

Identifier Type: -

Identifier Source: org_study_id

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