FULL DETAILS (Read-only)

CTRI Number  CTRI/2021/01/030605 [Registered on: 20/01/2021] Trial Registered Prospectively
Last Modified On: 25/06/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Immune profile of PIMS-TS  
Scientific Title of Study
Modification(s)  
Role of neutralizing antibodies and inflammatory biomarkers in children with Paediatric Inflammatory Multisystem Syndrome - Temporally Associated with SARS-CoV-2 (PIMS-TS) 
Secondary IDs if Any  
Secondary ID  Registry 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Aishwarya Venkataraman 
Address  Department of HIV/AIDS, National Institute for Research in Tuberculosis, No 1, Mayor Sathyamoorthy Road, Chetpet, Chennai

Chennai
TAMIL NADU
600031
India 
Phone    
Fax    
Email  draishwaryav@gmail.com  
 
Details Contact Person
Scientific Query

Modification(s)  
Name  Dr Aishwarya Venkataraman 
Address  Department of HIV/AIDS National Institute for Research in Tuberculosis, No 1, Mayor Sathyamoorthy Road, Chetpet, Chennai

Chennai
TAMIL NADU
600031
India 
Phone    
Fax    
Email  draishwaryav@gmail.com  
 
Details Contact Person
Public Query

Modification(s)  
Name  Dr Aishwarya Venkataraman 
Address  Department of HIV/AIDS National Institute for Research in Tuberculosis, No 1, Mayor Sathyamoorthy Road, Chetpet, Chennai

Chennai
TAMIL NADU
600031
India 
Phone    
Fax    
Email  draishwaryav@gmail.com  
 
Source of Monetary or Material Support
Modification(s)  
NIH-NIRT-ICER, ICMR-National Institute for Research in Tuberculosis, No.1, Mayor Sathiyamoorthy Road, Chetpet, Chennai - 600 031, INDIA 
 
Primary Sponsor  
Name  NIHNIRTICER 
Address  National Institute for Research in Tuberculosis, No 1, Mayor Sathyamoorthy Road, Chetpet, Chennai 600031 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 3  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr Aishwarya Venkataraman   ICER Lab NIRT  National Institute for Research in Tuberculosis, No 1, Mayor Sathyamoorthy Road, Chetpet, Chennai 600031
Chennai
 
04428369500

draishwaryav@gmail.com 
Dr S Elilarasi  Institute of Child Health  Department of PICU, Institute of Child Health Bhanumati, Rina Mandal Rd, Egmore, Chennai, Tamil Nadu 600008
Chennai
 
04428192138

elil.raghu@gmail.com 
Dr S Balasubramanian   Kanchi Kamakoti CHILDS Trust Hospital   Deaprtment of Paediatrics, Kanchi Kamakoti CHILDS Trust Hospital 12 A, Nageswara Rd, Tirumurthy Nagar, Nungambakkam, Chennai, Tamil Nadu 600034
Chennai
 
04442001800

sbsped@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Kanchi Kamakoti CHILDS Trust Hospital - Child trust medical research foundation IEC  Approved 
Madras Medical College, Chennai   Approved 
National institute for research in Tuberculosis   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Coronavirus as the cause of diseases classified elsewhere 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Stored serum or plasma samples from a previous approved study at KKCTH 
 
ExclusionCriteria 
Details  Caretakers and children who have not consented
Children admitted to PICU for conditions other than PIMS-TS
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
a. To identify the different immune phenotypes of PIMS-TS spectrum
b. Better understanding of immunology of children with PIMS-TS
c. One year serological follow up for PIMS-TS children
 
3, 6 and 12 months
 
 
Secondary Outcome  
Outcome  TimePoints 
a. Correlation of neutralizing antibodies with disease manifestation.
b. Correlation of various cytokines, chemokines, gene polymorphisms, complement proteins and other biomarkers with disease manifestation
c. Proportion of children with stable levels of neutralizing Abs at months 3 and 12
 
3 and 12 months 
 
Target Sample Size
Modification(s)  
Total Sample Size="200"
Sample Size from India="200" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  
25/01/2021 
Date of First Enrollment (Global)  No Date Specified 
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
Modification(s)  
nil 
Brief Summary  

Understanding the pathogenesis of PIMS-TS in children will provide important information on the distinguishing clinical features of the disease in children and provide evidence on some of the protective mechanisms. Analysing virus-specific neutralizing antibodies, induced by SARS-CoV-2 will provide novel information that will in turn develop strategies for treatment and prevention. Similarly, the analysis of biomarkers, including cytokines, chemokines, growth factors, gene polymorphisms and tissue repair factors would provide valuable information in both understanding pathogenesis of disease and elucidating the immune predictors of infection and disease.

 

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