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
|
|
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
|
|
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. |