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CTRI Number  CTRI/2023/08/056383 [Registered on: 10/08/2023] Trial Registered Prospectively
Last Modified On: 28/07/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   MIS-C treatment study 
Scientific Title of Study   Serial inflammatory responses in children receiving different treatment regimen for Multisystem Inflammatory Syndrome (MIS-C) - Longitudinal observational study from Southern India 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
227/NIRT-IEC/2021  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aishwarya Venkataraman 
Designation  Scientist E 
Affiliation  ICMR-NIRT 
Address  Department of clinical research, ICMR-National Institute for Research in Tuberculosis, No.1, Mayor Sathiyamoorthy Road, Chetpet, Chennai

Chennai
TAMIL NADU
600031
India 
Phone  0  
Fax    
Email  venkataraman.a@icmr.gov.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aishwarya Venkataraman 
Designation  Scientist E 
Affiliation  ICMR-NIRT 
Address  Department of clinical Research ICMR-National Institute for Research in Tuberculosis, No.1, Mayor Sathiyamoorthy Road, Chetpet, Chennai

Chennai
TAMIL NADU
600031
India 
Phone  0  
Fax    
Email  venkataraman.a@icmr.gov.in  
 
Details of Contact Person
Public Query
 
Name  Dr Aishwarya Venkataraman 
Designation  Scientist E 
Affiliation  ICMR-NIRT 
Address  Department of clinical Research ICMR-National Institute for Research in Tuberculosis, No.1, Mayor Sathiyamoorthy Road, Chetpet, Chennai

Chennai
TAMIL NADU
600031
India 
Phone  0  
Fax    
Email  venkataraman.a@icmr.gov.in  
 
Source of Monetary or Material Support  
ICMR-NIRT Intramural funds Department of clinical Research ICMR-National Institute for Research in Tuberculosis, No.1, Mayor Sathiyamoorthy Road, Chetpet, Chennai 
 
Primary Sponsor  
Name  ICMR-NIRT 
Address  ICMR-National Institute for Research in Tuberculosis, No.1, Mayor Sathiyamoorthy Road, Chetpet, Chennai - 600 031 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aishwarya Venkataraman  ICMR-NIRT  ICMR-National Institute for Research in Tuberculosis, No.1, Mayor Sathiyamoorthy Road, Chetpet, Chennai - 600 031
Chennai
TAMIL NADU 
914428369533

venkataraman.a@icmr.gov.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ICMR-NIRT   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: U071||COVID 19 virus identified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children and Adolescents who meet the criteria for CDC case definition of Multisystem inflammatory Syndrome  
 
ExclusionCriteria 
Details  1. Caretakers and children who have not consented 2. Children admitted to PICU for conditions other than MIS-C
3. Children on long term steroid and immunosuppressant therapy
4. Children with Adrenocortical insufficiency
5. Children with congenital or acquired immunodeficiency
6. Children who have received steroids before enrolment into study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The expected results of this study are likely to help our understanding of MIS-C & the different treatment options, which might help us to formulate a protocol or guidance for the management of MIS-C.  • Median cytokine levels (various cytokines) at day 0, day 2-3, & at day 5-7
• Reduction in proportion of cytokine levels in each group
 
 
Secondary Outcome  
Outcome  TimePoints 
• Correlation of cardiac markers with disease manifestation
• Correlation of Gene polymorphisms with disease manifestation
 
at baseline & discharge 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="54" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/08/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Multisystem Inflammatory Syndrome (MIS-C) is a complication of SARS-CoV-2 infection in children, which occurs 3-4 weeks after the acute infection due to a cytokine storm. Intravenous immunoglobulins (IVIG) and Steroids (Methyl prednisolone) are the main stay of treatment. However, we are yet to fully understand the immumopathological role of these treatments in MIS-C. Most of the clinicians and institutions around the world use both IVIG and Steroids, but few use either one of them. Early reports and experience of paediatricians suggest that different regimen seem to work equally. However, there is no evidence in identifying the right treatment pathway. Evidence is therefore, urgently needed to support treatment decisions for children with MIS-C. Through this study, we aim to evaluate the efficacy of different treatment regimen followed in various Paediatric intensive care units across Chennai, India in the management of MIS-C to reach a consensus.

Stored plasma samples from children aged 0 to ≤ 18 years, admitted to PICUs of various hospitals across Chennai, with MIS-C will be included in the study. We will be analysing the following on stored samples:

·         IL-6, IFNγ, TNFα, IL-2, IL-10, MIP-1a, GM-CSF, MCP-1, MI-1a

·         Neutrophil elastase, plasmin and alpha-1-antitrypsin

·         ProBnP and Troponin

Analysis will be performed on the 3 main groups formed based on the treatment received:

1) IVIG plus MPS; 2) IVIG alone; 3) MPS alone 


 
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