| 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
|
|
|
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
|
|
|
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
|