FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/06/026087 [Registered on: 23/06/2020] Trial Registered Prospectively
Last Modified On: 30/07/2020
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  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)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   10/07/2020 
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="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
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).
 
Close