| CTRI Number |
CTRI/2020/06/026087 [Registered on: 23/06/2020] Trial Registered Prospectively |
| Last Modified On: |
01/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Other |
|
Public Title of Study
|
Phase II, randomized, controlled, open-label study of
Pegylated IFN alfa-2b with SARS-CoV-2 |
|
Scientific Title of Study
|
A phase II, randomized, controlled, open-label study to
evaluate the efficacy and safety of Pegylated IFN alfa-2b in
the treatment of adult patients diagnosed with SARS-CoV2
(COVID-19). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PEGI.20.002,Version 3.12May2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kevinkumar Kansagra |
| Designation |
Deputy General Manager |
| Affiliation |
Cadila Healthcare Limited |
| Address |
Zydus Research Center,Survey No. 396/403, Sarkhej-Bavla National Highway No.8A,Moraiya
Ahmadabad
GUJARAT
382213
India |
| Phone |
91271766535 |
| Fax |
|
| Email |
kevinkumarkansagra@zyduscadila.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kevinkumar Kansagra |
| Designation |
Deputy General Manager |
| Affiliation |
Cadila Healthcare Limited |
| Address |
Zydus Research Center,Survey No. 396/403, Sarkhej-Bavla National Highway No.8A,Moraiya
GUJARAT
382213
India |
| Phone |
91271766535 |
| Fax |
|
| Email |
kevinkumarkansagra@zyduscadila.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kevinkumar Kansagra |
| Designation |
Deputy General Manager |
| Affiliation |
Cadila Healthcare Limited |
| Address |
Zydus Research Center,Survey No. 396/403, Sarkhej-Bavla National Highway No.8A,Moraiya
GUJARAT
382213
India |
| Phone |
91271766535 |
| Fax |
|
| Email |
kevinkumarkansagra@zyduscadila.com |
|
|
Source of Monetary or Material Support
|
| Cadila Healthcare Limited,
Zydus Research Center,
Survey No. 396/403,
Sarkhej-Bavla National Highway No.8A
Moraiya, Ahmedabad - 382213 |
|
|
Primary Sponsor
|
| Name |
Cadila Healthcare Limited Zydus Research Center |
| Address |
Cadila Healthcare Limited,
Zydus Research Center,
Survey No. 396/403,
Sarkhej-Bavla National Highway No.8A
Moraiya, Ahmedabad - 382213 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anuja Pandit |
AIIMS |
Dept Of Onco Anaesthesia and Palliative Medicine,
National Cancer Institute, Jhajjar
AIIMS, New Delhi
New Delhi
DELHI |
9710030457
anujapandit@yahoo.co.in |
| Dr Koradia Parshottam Govindbhai |
BAPSPramukhSwami Hospital |
ShriPramukhSwamiMaharaj Marg
AdajanCharRoadAdajan
Surat 395009 Gujarat India
Surat
GUJARAT |
9825312027
purushottam_koradia@yahoo.co.in |
| Dr Nirav Bhalani |
Rhythm Heart Institute |
Near Siddharth Bungalows, Sama Savli Road,Vadodara – 390022 Gujarat, India
Vadodara
GUJARAT |
8128995863
drniravbhalani@hotmail.com |
| Dr Vinay Bhomia |
Sanjivani Super Speciality Hospital Pvt. Ltd |
1, Uday park Society, Nr. Sunrise Park, Vastrapur Ahmedabad – 380015, Gujarat, India
Ahmadabad
GUJARAT |
9825007385
drvinaybhomia@gmail.com |
| Dr Shweta Gargiya |
Tapan Research Centre |
Basement Tapan Hospital
Near Platinum Hall
Anandnagar Cross Road
Satellite, Ahmedabad – 380015
Gujarat, India
Ahmadabad
GUJARAT |
963822666
shwetagargiya@gmail.com |
| Dr Shashi Bhushan B L |
Victoria Hospital Bangalore Medical College and Research Institute |
Fort K R Road Bangalore Urban
Karnataka 560002
India
Bangalore
KARNATAKA |
9448239644
shashibhushanbl@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| BAPSPramukhSwamiHospital InstitutionalEthicsCommittee BAPSPramukhSwamiHospital ShriPramukhSwamiMaharajMarg AdajanCharRoad AdajanSurat395009GujaratIndia |
Approved |
| Ethics Committee Of BMCRI Bangalore Medical College And Research Institute Fort K R Road Bengaluru Urban Karnataka 560002 India |
Approved |
| IEC, AIIMS, Room No 102, 1st Floor Old OT Block, Ansari Nagar, New Delhi - 110029 |
Approved |
| Rhythm Heart Institute Ethics Committee Rhythm Heart Institute Near Siddharth Bunglows Sama- Savli Road Vadodara Gujarat – 390022 India |
Approved |
| Sanjivani Hospital Ethics Committee Sanjivani Super Speciality Hospital Pvt.Ltd. 1,Uday Park Society, Near Sunrise Park Vastrapur Vastrapur Ahmedabad Gujarat - 380015 India |
Approved |
| Vrajesh Hospital Institutional Review Board Shree Vrajesh Surgical Hospital Opposite Rajpath Club Cargo Motors lane, S.G. road, 117 Bodakdev Ahmedabad Gujarat - 380015 India |
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Pegylated alpha 2b and Standard of care |
Administer Day 1 and Day 8
Route-Subcutaneous
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Ability to comprehend and willingness to sign a written ICF for the study.
2. Male or non-pregnant females, ≥18 years of age at the time of enrolment.
3. Understands and agrees to comply with planned study procedures.
4. Agrees to the collection of pharyngeal swabs and blood sample as per protocol.
5. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other
commercial or public health assay in any specimen
6.Women of childbearing potential must agree to use at least one primary form of
contraception for the duration of the study (acceptable methods will be determined
by the site). |
|
| ExclusionCriteria |
| Details |
1. Pregnant or breast feeding.
2. Allergy to any study medication.
3. Severe co-morbidity (e.g. uncontrolled hypertension and uncontrolled DM, systemic disease which affect the vital organs severity, immunocompromised patients etc.) as per investigator’s assessment.
4. Comorbid condition like myocardial infarction or heart failure within 90 days of recruitment. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluation of the clinical efficacy of Pegylated IFN-α2b on the basis of change in ordinal
scale. |
week 2 and week 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Qualitative and quantitative PCR for SARS-CoV-2 in pharyngeal swab.
2) Safety and tolerability |
screening
day, day 7 and day 14 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
08/07/2020 |
| Date of Study Completion (India) |
04/09/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A phase II, randomized, controlled, open-label study to evaluate the efficacy and safety of Pegylated IFN alfa-2b in the treatment of adult patients diagnosed with SARS-CoV2 (COVID-19). |