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CTRI Number  CTRI/2020/11/029061 [Registered on: 11/11/2020] Trial Registered Prospectively
Last Modified On: 25/12/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Multisystemic inflammatory syndrome in children (MIS-C) in COVID pandemic 
Scientific Title of Study   Clinical profile and outcome of Multisystemic inflammatory syndrome in children (MIS-C) in COVID pandemic – An observational study from a paediatric tertiary care centre 
Trial Acronym  MIS-C 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dr S Elilarasi  
Designation  Director and Professor  
Affiliation  Institute of Child health 
Address  Institute of Child health, Madras Medical College, Chennai
Bhanumati, Rina Mandal Rd, Egmore, Chennai, Tamil Nadu 600008
Chennai
TAMIL NADU
600003
India 
Phone    
Fax    
Email  elil.raghu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr S Elilarasi  
Designation  Director and Professor  
Affiliation  Institute of Child health, 
Address  Institute of Child health, Madras Medical College, Chennai
Bhanumati, Rina Mandal Rd, Egmore, Chennai, Tamil Nadu 600008
Chennai
TAMIL NADU
600003
India 
Phone    
Fax    
Email  elil.raghu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr V Poovazhagi  
Designation  Head of the Department, PICU 
Affiliation  Institute of Child health 
Address  Institute of Child health, Madras Medical College, Chennai
Bhanumati, Rina Mandal Rd, Egmore, Chennai, Tamil Nadu 600008
Chennai
TAMIL NADU
600003
India 
Phone    
Fax    
Email  poomuthu@gmail.com  
 
Source of Monetary or Material Support  
ICH &HC, Madras Medical College, Chennai  
 
Primary Sponsor  
Name  ICH HC Madras Medical College Chennai 
Address  ICH &HC, Madras Medical College, Chennai 
Type of Sponsor  Government medical college 
 
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 V Poovazhagi   Institute of Child Health  Depart of Pediatric intensive care unit, Institute of Child health, Madras Medical College, Chennai
Chennai
TAMIL NADU 
9840033020

poomuthu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ICH MMC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children admitted to PICU with MIS-C 
 
ExclusionCriteria 
Details  Non MIS-C Children 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To identify the different phenotypes of MIS-C. spectrum
Time forn ormalisation of clinical symptoms of fever and rash
Time for normalization of lab abnormalities of inflammatory markers ESR CRP
 
3, 6, 9 ,12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of complications related to therapy
Length of hospital stay
One year follow up for different organ system involvement
Mortality (all-cause)
 
3, 6, 9 ,12 months 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/11/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

         Multisystem inflammatory syndrome in children is a new entity being diagnosed  in the recent few months in children  during  and following covid infection in this pandemic. The spectrum of MIS-C can present with   mild symptoms or typical Kawasaki like illness or like  atypical Kawasaki like illness or toxic  shock syndrome like or  with macrophage activation syndrome. This  is named as   MIS –C(by WHO & CDC) or  PIMS TS (pediatric  multisystem inflammatory syndrome  temporally associated with SARS- Covid 19) by different  groups . Children rarely become sick to be hospitalized   in comparison to adults with Covid infection.  Majority of the studies  have shown the involvement as post inflammatory  rather than with acute infection in children . Once they develop  MIS C  they may need hospitalization and if sick  they need  intensive care and therapy with IVIG.

 

      Current  information  on this new clinical condition is based on the western literature  who had their pandemic  little earlier than  India. Majority of the  literature suggests that the presentation is usually  following the covid-19  peak among adults.This usually occurs  3-4 weeks contact or infection  in children.  Based on the recently published literature elsewhere majority of these children were found to be negative for the  covid 19 viral PCR but have  IgG antibodies  to COVID 19. The World Health Organization (WHO) has created a working group of experts from all over the world to begin investigating cases to establish evidence on whether Covid-19 can lead to multiorgan failure also in this age group.CDC and WHO defines this condition as  multisystem inflammatory syndrome  in children,  MIS-C and  as a serious complication of the disease. This has also been defined as pediatric multisystem inflammatory syndrome in children temporally associated with SARS Covid 19  called  PIMS-TS.  Not much  literature is available as on date from India  regarding this newly coined disease. Based on the available literature from Europe and North America  clinical presentation can be mild, moderate or severe  disease resulting in mortality if not recognized.  Mild disease without  shock or  severe cardiac involvement or any other  significant  organ involvement  may not  need any specific treatment   while the moderate and severe ones may need ICU  treatment with IVIG/and Methylprednisolone and /or biologicals like  Tocilizumab therapy . But for occasional case  reports  of the condition  from India it  is yet  to be familiar  to the pediatricians. Not  many pediatricians  are aware of such clinical  conditions in the absence of literature from India and this disease is likely to  increase  following  the adultpeak of COVID infection  in different parts of the country.

 

                        Recently the Pediatric Intensive Care unit  of ICH &HC  has  encountered  increasing  number of children with features  suggestive of  this multisystem inflammatory syndrome, which  varies from mild symptomatic  with no multiorgan involvement  to severe involvement in the form of Kawasaki disease  like, atypical Kawasaki disease (KD) like ,  toxic shock syndrome (TSS)like in  vasoplegic  shock and   macrophage activation syndrome (MAS) phenotypes .   The data over  past  5 weeks in PICU has shown an alarmingly increasing  number of approximately 10 times.in number  with features of severe involvement of  heart, and other organs like  liver , kidney ,  pancreas  other multi organ dysfunction syndrome. Some of these children in  intensive care  were started on   multiple inotropes, and  ventilator support too , with ejection fraction as low as 15 %.  Though this KD   phenotype  has differences from typical Kawasaki disease.  IVIG  alone or  along with methylprednisolone has been the suggested modality of therapy based on the severity of myocardial involvement.MAS  is life threatening and unless recognized  mortality is high. .Due to the variant nature of the disease and the temporal association  to  covid,  the  course and outcome  and long term follow up need to be studied.  These children  need  to be followed up   for their morbidity  as there is no existing literature on this newly identified life threatening  disease in children.

                          The use of  immunomodulants  like  IVIG  with or without methylprednisolone are  used  in the acute phase of KD in children can  be expected  to reduc incidence of coronary artery aneurysms, duration of clinical symptoms (fever, rash), time for laboratory parameters to normalise (CRP, ESR) and length of hospital stay .In the absence of   much published   literature  from India on this  condition, it is prudent to have  regional data and the presentation of children their course and outcome .

   Children with  hyperinflamatory syndrome are  much older, more likely to have  gastrointestinal symptoms like vomiting , diarrhea  abdominal pain. These children  are  likely to  have a spectrum  of   features  involving  multiple organs .  The lab parameters  are  more likely to be  thrombocytopenia   lower absolute  lymphocyte counts lymphopenia and much higher  CRP levels..

             There is  an urgent need to study the presentation of these children and plan for appropriate management  as a team . ICH &HC being the apex  pediatric institute in the state,  is  one of the high load  centers and there is an urgent need to study  the disease spectrum and its outcome in our setting  as it  is evolving .


  1. Objectives / Aim         

         (a)  To study the clinical presentation and course of  Multisystemic inflammatory syndrome in

               children(MIS-C)/Pediatric multisystem inflammatory syndrome in children temporally

               associated with SARS COVID 19 (PIMS-TS)

          (b)To correlate the laboratory parameters and   outcome of  children with MIS-C/ PIMS -TS

          (c) Follow up of children with MIS-C/PIMS –TS  over  a period of 12 months


 
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