FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/12/029855 [Registered on: 16/12/2020] Trial Registered Prospectively
Last Modified On: 30/03/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Other 
Public Title of Study   Phase III, Randomized, Controlled, Open-Label Study of Pegylated Interferon Alfa-2b With SARS-CoV-2 
Scientific Title of Study   A Phase III, Randomized, Controlled, Open-Label Study to Evaluate the Efficacy and Safety of Pegylated Interferon Alfa-2b In the Treatment of Adult Patients Diagnosed With SARS-CoV-2 (COVID-19). 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
PEGI.20.005 Versoion 02,02 December 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manjunath K 
Designation  Deputy General Manager 
Affiliation  Cadila Healthcare Limited 
Address  Zydus Research Center, Survey No. 396/403, Sarkhej-Bavla National Highway No.8A Moraiya, Ahmedabad - 382213

Ahmadabad
GUJARAT
382213
India 
Phone    
Fax    
Email  Manjunath.K@zyduscadila.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kevinkumar Kansagra 
Designation  General Manager 
Affiliation  Cadila Healthcare Limited 
Address  Zydus Research Center, Survey No. 396/403, Sarkhej-Bavla National Highway No.8A Moraiya, Ahmedabad - 382213

Ahmadabad
GUJARAT
382213
India 
Phone    
Fax    
Email  kevinkumarkansagra@zyduscadila.com  
 
Details of Contact Person
Public Query
 
Name  Dr Balaji More 
Designation  Senior General Manager 
Affiliation  Cadila Healthcare Limited 
Address  Zydus Research Center, Survey No. 396/403, Sarkhej-Bavla National Highway No.8A Moraiya, Ahmedabad - 382213

Ahmadabad
GUJARAT
382213
India 
Phone    
Fax    
Email  balaji.more@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  Zydus Research Center Cadila Healthcare Limited 
Address  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 = 20  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sandeep Kumar Gupta  atharva multi specialityhospitl and research centre  H-4/Comm-2, Constuction Div -21, , UP Avas Vikas Parishad, Sector E, Lucknow , Uttar Pradesh - 226003 India
Lucknow
UTTAR PRADESH 
9336077839

sandeepkumar.gupta@rediffmail.com 
Dr Sunil Wanve  BAJ RR Hospital Research Centre  P 14 M.I.D.C. Phase I, Milap Nagar, Dombivali East Maharashtra India 421203
Thane
MAHARASHTRA 
9820328503

drsunilwanve52@gmail.com 
Dr Koradia Parshottam Govindbhai  BAPS Pramukh Swami Hospital  Shri Pramukh Swami Maharaj Marg Adajan Char Road Adajan Surat 395009 Gujarat India
Surat
GUJARAT 
9825312027

purushottam_koradia@yahoo.co.in 
Dr Sisir Chakraborty  College of Medicine & Sagore Dutta Hospital  578 , BT Road, Kamahati, Kolkata 700058 - India
Kolkata
WEST BENGAL 
8240565690

chakrabortysisir@yahoo.co.in 
Dr Mahamine Kaustubh Suryakant   Dr. Vasantrao Pawar Centre for Development Therapeutics translation Research  4th Floor Near MRD Section in Medical College, Dr. Vasanatrao Pawar Medical College, Hospital and Research Centre, Vasantdada Nagar, Adgaon, Nashik – 422003 , Maharashta, India
Nashik
MAHARASHTRA 
7506117341

drkaustubhmahamine@gmail.com 
Dr Nikhil Verma  ESIC Medical College and Hospital  NH - 3 NIT Behind BK Hospital, Faridabad Haryana - 121001
New Delhi
DELHI 
7000798104

drnick.ver@gmail.com 
Dr Manoj Kumar Singh  Flores Hospital  Block G, Sector 11, Pratap Vihar Ghaziabad
New Delhi
DELHI 
7877110499

drmanoj73kumar@gmail.com 
Dr Nischal Yalgi  Global Hospital & Research Institute  577/2 off Sinhgad Road, Near Dattawadi Police Chowki, Dattawadi, Pune – 411030 Maharashtra India
Pune
MAHARASHTRA 
9168764422

drnischalyalgi@gmail.com 
Dr Parul Bhatt  GMERS Medical college and Civil Hospital  Department of Medicine GMERS Medical college and Civil Hospital, Sola Nr Gujarat High Court, S G Highway, Sola Ahmedabad, Gujarat – 380060, India
Ahmadabad
GUJARAT 
9879599595

parulbhatt30@yahoo.com 
Dr Saurabh Agarwal  GSVM Medical College,  Department of Medicine GSVM Medical College, Swaroop Nagar, Kanpur – 208002 Uttar Pradesh
Kanpur Nagar
UTTAR PRADESH 
9415039582

saurabh.gsvmmed@gmail.com 
Dr Rajnish Nagarkar  HCG Manavata Cancer Centre  HCG Manavata Cancer Centre Behind Shivang Auto, Mumbai Naka, Nashik-422002 Maharashtra, India
Nashik
MAHARASHTRA 
9823061929

drraj@manavatacancercentre.com 
Dr Archana Andhavarapu  Mallareddy Narayana Multispeciality Hospital  Suraram X Roads, Jeedimetla, Hyderabad, Telangana 500055
Hyderabad
TELANGANA 
7729971707

andhavarapuarchana@gmail.com 
Dr Tanmay Bandyopadhyay  Medical Super Specialty Hospital  127, Mukundapur, E.M. By pass, Kolkata – 700099
Kolkata
WEST BENGAL 
9433427474

tanmay.banerjee@medicasynergie.in 
Dr Pravin Soni  PGI Yashwantrao Chavan Memorial Hospital  PCMC’S PGI Yashwantrao Chavan Memorial Hospital Sant Tukaram Nagar Pimpri, Pune – 411018
Pune
MAHARASHTRA 
9822057511

drpravinsoni18@gmail.com 
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 Akash Khobragade  St. George’s Hospital  First Floor,Medical Superintendent Office, St. George’s Hospital, P D’Mello Road, Behind GPO, Fort, Mumbai-400001. Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 
9702658822

akash.khobragade@gmail.com 
Dr Arti Shah  Sumandeep Vidyapeeth Institute  Department of Respiratory Medicine Sumandeep Vidyapeeth an Institute Deemed to be University & Dhiraj Hospital At. & Po. Piparia - Ta. Waghodia Vadodara-391760
Vadodara
GUJARAT 
9925047880

artidhawal76@gmail.com 
Dr Divyang Dalwadi  Tapan Research Centre  Basement Tapan Hospital Near Platinum Hall Anandnagar Cross Road Satellite, Ahmedabad – 380015 Gujarat, India
Ahmadabad
GUJARAT 
9909913087

drdivyang87@gmail.com 
Dr Shashi Bhushan B L  Victoria Hospital  B - Block Ground Floor 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= 20  
Name of Committee  Approval Status 
" Altezza Institutional Ethics Committee, Shree Ashirwad Hospital C/3 Shree Complex Opposite Mahavir Road,Manpada Road Dombivli Thane Maharashtra - 421201 India"  Approved 
" INSTITUTIONAL ETHICS COMMITTEE , GGMC, MUMBAI Grant Govt Medical College, JJ Road, JJ Hospital compound Mumbai Central Mumbai Mumbai City Maharashtra - 400008 India "  Approved 
"Institutional Ethics Committee Yashwantrao Chavan Memorial Hospital, Pimpri Sant Tukaram Nagar, Near D.Y.Patil Medical College Vallabhnagar, Near Fire Brigade Station, Pimpri Pune Maharashtra - 411018 India"  Approved 
BAPS Hospital Institutional Ethics Committee BAPS Pramukh Swami Hospital BAPS Pramukh Swami Hospital Adajan Cross Road, Adajan Surat Surat Gujarat - 395009 India  Approved 
Clinical Research Ethics committee Medical Super Specialty Hospital 127, Mukundapur, E.M. By pass, Kolkata – 700099  Approved 
Ethics Committe GSVM Medical College, Swaroop Nagar, Kanpur – 208002 Uttar Pradesh  Approved 
Ethics Committee Of BMCRI Bangalore Medical College And Research Institute Fort K R Road Bengaluru Urban Karnataka 560002 India  Approved 
IEC for atharva multi specialityhospitl and research centre, H-4/Comm-2, Constuction Div -21, , UP Avas Vikas Parishad, Sector E, Lucknow , Uttar Pradesh - 226003 India  Approved 
IEC, Dr. Vasantrao Pawar Medical College, Dr. Vasanatrao Pawar Medical College, Hospital and Research Centre, Vasantdada Nagar, Adgaon, Nashik Maharashtra - 422003 India  Approved 
Institutional Ethics Committee SV, Sumandeep Vidyapeeth At & Post. Piparia - Ta. Waghodia Vadodara-391760  Approved 
Institutional Ethics Committee College of Medicine & Sagore Dutta Hospital Office of Pricipal, 578 , BT Road, Kamarhati, Kolkata 700058 - India  Approved 
Institutional Ethics Committee for Sehgal Nursing Home Sehgal Nursing Home, A 6 Panchwati , opp Azadpur New Sabzi Mandi - Delhi 110033  Approved 
Institutional Ethics Committee for Sehgal Nursing Home Sehgal Nursing Home, A 6 Panchwati , opp Azadpur New Sabzi Mandi - Delhi 110033  Approved 
Institutional Ethics Committee GMERS Medical college and Civil Hospital, Sola Department of Pharmacology 4th Floor College Building, Nr. Gujarat High Court, S G Highway, Sola Ahmedabad, Gujarat – 380061, India  Approved 
Institutional Ethics Committee Malla Reddy Medical College For Women Suraram X Road Qutbullapur, Municipality, Jeedimetla Hyderabad Telangana - 500055 India  Approved 
Institutional Ethics Committee Sai Sneh Hospital and Daignostic Centre Opp. PMT Bus Depot Pune Satara Road Katraj Pune Maharashtra - 411046 India  Approved 
Manavata Clinical Research Institute Ethics Committee HCG Manavata Cancer Centre Behind Shivang Auto, Mumbai Naka, Nashik , Maharashtra– 422002 India  Approved 
Rhythm Heart Institute Ethics Committee Rhythm Heart Institute Near Siddharth Bunglows Sama- Savli Road Vadodara Gujarat – 390022  Approved 
Sanjivani Super Speciality Hospital Pvt. Ltd 1, Uday Park Society, Nr. Sunrise Park, Vastrapur, Ahmedabad – 380015, Gujarat 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  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
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  Pegylated IFN-α2b and Standard of care  Single dose of Pegylated IFN- α2b (1 mcg/kg) along with the recommended standard of care at the time of conduct of trial. 
Comparator Agent  Standard of care  recommended standard of care at the time of conduct of trial. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 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 RT-PCR within 5 days of
enrollment.
6. Patients with pneumonia with no signs of severe disease, respiratory rate ≥24breaths/minute,
SpO2 90%- 94%.
7. Illness of any duration, and at least one of the following:
a. Radiographic infiltrates by imaging (chest x-ray/CT scan)
b. Clinical assessment (evidence of rales/crackles or other clinical symptoms related to COVID-19 on examination).
8. Women of childbearing potential must agree to use at least one primary form of contraception
for the entire duration of the study (acceptable methods will be determined by the site). 
 
ExclusionCriteria 
Details  1. ALT/AST >5 times the upper limit of normal.
2. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30).
3. Pregnant or breast feeding.
4. Allergy to any study medication.
5. 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.
6. Comorbid condition like myocardial infarction or heart failure within 90 days of recruitment.
7. Prolong QT interval (>450 ms). 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Evaluation of the clinical efficacy of Pegylated interferon alfa-2b on the basis of change in ordinal
scale at Day 11 ± 1. 
baseline to Day 11 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluation of the clinical efficacy of Pegylated interferon alfa-2b on the basis of change in ordinal scale  screening to Day 8, Day 11 and Day 15. 
Proportion of subjects who are found negative to SARS-CoV-2 based on Qualitative and
Quantitative (Based on the CT value) RT-PCR. 
screening to Day 7, Day 11and Day 15 
Occurrence and duration (days) of supplemental oxygen.  Screening to Day 15  
Occurrence and duration (days) of mechanical ventilation.  Screening to Day 15 
Time to resolution of clinical signs and symptoms.  Screening to Day 15 
Incidence of adverse events and serious adverse events.  Screening to Day 15 and Day 29 
Duration of hospitalization.  Screening to Day 15 
Change in white blood cell count, haemoglobin, platelets, creatinine, glucose, total bilirubin,
ALT, and AST  
screening to Day 3, Day 7, Day 15 
Change in C-reactive protein, IL-6, D-dimer and Ferritin   screening to Day 3, Day 7 and
Day 15. 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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 3 
Date of First Enrollment (India)
Modification(s)  
17/12/2020 
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="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
The current evolving standard of care in the treatment of COVID-19 patients appears to be in using anti-viral agents (e.g. Remdesivir/ritonavir/liponavir etc.). In early phase II study in the treatment of adult patients diagnosed with SARS-CoV2, there was statistical significant difference observed in clinical improvement in Pegylated Interferon alfa-2b +
SOC group compared to SOC alone from day 0 to day 15. Overall, single dose of Pegylated Interferon alfa-2b was safe and well tolerated. Therefor proposed Phase III study is designed to test whether CHL’s Pegylated Interferon alfa-2b can provide additional benefit to these patients in terms of reduced rate of hospitalization and better time to recovery.
 
Close