Multicentric observational study on Pediatric Multisystem Inflammatory Syndrome (PMIS) related to Covid-19
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/11/029030
- Lead Sponsor
- Dr Dhiren Gupta
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Fever > 38â??C for >=24 hours in last 7 days
2. Evidence of clinically severe hospitalized illness among children aged <18 years with multisystem (>=2) organ involvement
(cardiac, renal, respiratory, hematologic, gastrointestinal, dermatologic or neurological) see table for definitions used for organ involvement.
3. Elevated markers of inflammation (eg, neutrophilia; lymphopenia; hypoalbuminemia; and elevated levels of C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), fibrinogen, procalcitonin, d-dimer, ferritin, lactic acid dehydrogenase (LDH), or interleukin 6 (IL-6)]
4. No other obvious microbial cause of inflammation, including bacterial sepsis and staphylococcal/streptococcal toxic shock syndromes
5. Evidence of SARS-CoV-2 infection (Any of the following):
5.1. Positive SARS-CoV-2 RT-PCR
5.2. Positive serology
5.3. Positive antigen test
5.4. Negative for SARS-CoV-2 RT-PCR and antibody tests but with identified COVID-19 exposure within the four weeks prior to the onset of symptoms
1. Hospital stay < 24 hours
2. Presence of other obvious microbiological cause of inflammation/ clinical condition
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MortalityTimepoint: At the time of discharge from hospital
- Secondary Outcome Measures
Name Time Method Demographics, Clinical symptoms, clinical examination findings, Laboratory values, treatment modalities usedTimepoint: 6 months