| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
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 .
- 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
|