| CTRI Number |
CTRI/2021/06/034327 [Registered on: 21/06/2021] Trial Registered Prospectively |
| Last Modified On: |
17/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Viral Infection Study |
|
Scientific Title of Study
|
Effect of short term inhaled Budesonide in children with mild COVID 19 infection an open labeled randomized controlled trial |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IBC-MC19 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ayesha Mariam |
| Designation |
Senior Registrar |
| Affiliation |
Apollo Children’s Hospital |
| Address |
Department of Paediatrics
Apollo Children’s Hospital
No. 15, Shafi Mohammed Road, Thousand Lights, Chennai
Chennai
TAMIL NADU
600006
India |
| Phone |
|
| Fax |
|
| Email |
ayesha.mariam@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ayesha Mariam |
| Designation |
Senior Registrar |
| Affiliation |
Apollo Children’s Hospital |
| Address |
Department of Paediatrics
Apollo Children’s Hospital
No. 15, Shafi Mohammed Road, Thousand Lights, Chennai
TAMIL NADU
600006
India |
| Phone |
|
| Fax |
|
| Email |
ayesha.mariam@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ayesha Mariam |
| Designation |
Senior Registrar |
| Affiliation |
Apollo Children’s Hospital |
| Address |
Department of Paediatrics
Apollo Children’s Hospital
No. 15, Shafi Mohammed Road, Thousand Lights, Chennai
TAMIL NADU
600006
India |
| Phone |
|
| Fax |
|
| Email |
ayesha.mariam@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Apollo Hospitals,
No.15, Shafi Mohammed Road, Thousand Lights, Chennai |
|
|
Primary Sponsor
|
| Name |
Apollo Hospitals |
| Address |
Off Greams Lane
Greams Road Chennai
600006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ayesha Mariam |
Apollo Children’s Hospital |
Apollo Children’s Hospital
Department of Pediatrics
No. 15, Shafi Mohammed Road, Thousand Lights, Chennai- 600006.
Chennai
TAMIL NADU |
09916887346
ayesha.mariam@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee – Biomedical research |
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
|
| Type |
Name |
Details |
| Intervention |
Budesonide 400 mcg |
twice daily for 7 days |
| Comparator Agent |
Standard of Care |
Vitamin C and zinc supplements
once daily for 14 days |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Confirmed diagnosis of COVID 19 infection(COVID RT-PCR positive or HRCT suggestive of CORADS 4/5/6)
Mild disease presenting within the first 7 days of illness |
|
| ExclusionCriteria |
| Details |
Children with moderate or severe COVID 19 infection at presentation.
Children with comorbidities on immunosuppressants or on steroids.
Parents or guardian not consenting to be part of the study. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect on disease progression in children affected with COVID 19 |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect on symptom control |
14 days |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
30/06/2021 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Coronavirus Disease 2019 (COVID 19) has run a mild course in majority of
children. The second wave in India has been accompanied by a significant
increase in pediatric population, though the severity of the disease in this
age group has been milder than the adult counterpart till now. Research in
pediatric COVID 19 treatment has been scarce mainly due to the benign course of
the illness but this might not be the case with future mutation in the COVID 19
which is part of the disease characteristics. In adults with pre-existing
condition like diabetes and hypertension or people above 60 years with mild
disease, inhaled budesonide has been useful in preventing progression of this
condition and has been found to be safe to use. With varied duration of
symptoms noted with children even in a benign course, our open label randomized
controlled trial is looking into the use of budesonide as a therapeutic option
in preventing progression and reducing the time duration of associated
symptoms. |