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CTRI Number  CTRI/2021/12/039054 [Registered on: 30/12/2021] Trial Registered Prospectively
Last Modified On: 19/06/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Study of immune markers in multisystem inflammatory syndrome in children (MIS-C) 
Scientific Title of Study   A multicentric, longitudinal study on measurement of Immune Responses in Multisystem Inflammatory Syndrome in Children (MIS-C) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amrita Pattanaik 
Designation  Assistant Professor 
Affiliation  Manipal Institute of Virology 
Address  Room no.110, Department of virus research, Manipal Institute of Virology, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  amrita.pattanaik@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Amrita Pattanaik 
Designation  Assistant Professor 
Affiliation  Manipal Institute of Virology 
Address  Room no. 110 Department of Virus Research, Manipal Institute of Virology, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  amrita.pattanaik@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Amrita Pattanaik 
Designation  Assistant Professor 
Affiliation  Manipal Institute of Virology 
Address  Room no.110, Department of virus research, Manipal Institute of Virology, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  amrita.pattanaik@manipal.edu  
 
Source of Monetary or Material Support  
Indian Council of Medical Research 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Suchetha S Rao  Kasturba Medical College and Hospital, Mangalore  Additional Professor, Department of Pediatrics
Dakshina Kannada
KARNATAKA 		 9901765707

suchetha.rao@manipal.edu 
Dr Shrikiran A  Kasturba Medical College and Hospital, Manipal  Professor, Department of Pediatrics
Udupi
KARNATAKA 		 9448177671

shrikiran.a@manipal.edu 
Dr Somashekar AR  MS Ramaiah Medical College and Hospital, Bangalore  Professor and Head, Department of Pediatrics
Bangalore
KARNATAKA 		 9845212616

s_arshekar2002@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committe  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 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  19.00 Year(s)
Gender  Both 
Details  Study group:
Patients diagnosed to be MIS-C cases by the treating physicians and co-investigators at the three collaborating centres (Kasturba Medical College, Manipal; Kasturba Medical College, Mangalore and Ramaiah Medical College, Bangalore) as per the WHO case definition.
Control groups:
There will be three sub-groups in this:
A) SARS-CoV-2 RT PCR positive patients in the age group, 0 – 19, not fitting into the WHO case definition of MIS-C.
B) Age matched healthy controls who are negative for SARS-CoV-2 RT-PCR and do not have signs and symptoms of any ongoing infection.
C) Children were classified as having complete/incomplete Kawasaki Disease (KD) by using American Heart Association criteria 
 
ExclusionCriteria 
Details  Subjects on immunomodulatory therapy for samples obtained following the first visit to the treating physician 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Plasma cytokines, sC5b-9 and anti SARS-CoV-2 IgG and neutralizing antibody levels along with clinical correlation may help diagnose and differentiate MIS-C from other conditions with overlapping clinical features like Kawasaki disease.  At first visit and follow up after 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
Understand the pathophysiology of MIS-C  At first visit and follow up after 1 month 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="200" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/01/2022 
Date of Study Completion (India) 14/06/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Background: Multisystem inflammatory syndrome in children (MIS-C) is a hyperinflammatory condition that is being reported in regions with receding SARS-CoV-2 infection peaks. The pathophysiology of MIS-C has not been explored much. Here, in such cases we will be profiling aberrant immune activation and its alteration with therapy.
Novelty: Measuring plasma levels of a broad range of pro-inflammatory biomarkers may not only help in understanding the pathophysiology of MIS-C but also differentiate it from similar hyperinflammatory conditions like Kawasaki disease. None of the prior studies have looked at the cytokine responses before and after the therapeutic intervention. Also, deeper immunophenotyping is required in different geographies where comorbidities and genetic background differ and may have a role to play in the prognosis. There is a dearth of Indian data on immune responses in MIS-C.
Objectives: To measure the immune responses in MIS-C patients at two time points, before and after therapeutic intervention and compare it with the control groups.
Methods: Study and control subjects in the age-group 0 -19 years, fulfilling the inclusion and exclusion criteria will be enrolled. After a detailed clinical evaluation, the following tests will be done:
a. ELISA to detect IgG antibodies against SARS-CoV-2 virus
b. Surrogate assay for the detection of SARS-CoV-2 neutralizing antibodies
c. Soluble C5b-9 assay by ELISA
d. Proinflammatory biomarkers multiplex assay
Expected outcome: Plasma cytokines and other biomarkers, sC5b-9 and anti SARS-CoV-2 IgG and neutralizing antibody levels along with clinical correlation may help diagnose and differentiate MIS-C from other conditions with overlapping clinical features like Kawasaki disease. It may also help in the prognostication. Assessing a wider range of biosignatures may also give a better understanding of the pathophysiology of this hyperinflammatory condition.
 
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