PDF of Trial

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Clinical Trial Details (PDF Generation Date :- Thu, 27 May 2021 02:01:07 GMT)

CTRI Number Last CTRI/2020/12/029855 [Registered on: 16/12/2020] - Trial Registered Prospectively
Modified On 30/03/2021
Post Graduate Thesis No
Type of Trial Interventional
Type of Study Biological
Other
Study Design
Phase III, Randomized, Controlled, Open-Label Study of Pegylated Interferon Alfa-2b With
Public Title of Study
SARS-CoV-2
A Phase III, Randomized, Controlled, Open-Label Study to Evaluate the Efficacy and Safety of
Scientific Title of Pegylated Interferon Alfa-2b In the Treatment of Adult Patients Diagnosed With SARS-CoV-2
Study (COVID-19).
Secondary ID Identifier
Secondary IDs if Any
PEGI.20.005 Versoion 02,02 December 2020 Protocol Number
Details of Principal Investigator
Details of Principal Name Dr Manjunath K
Investigator or overall
Designation Deputy General Manager
Trial Coordinator
(multi-center study) 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 [email protected]
Details Contact Person (Scientific Query)
Name Dr Kevinkumar Kansagra
Details Contact
Person (Scientific Designation General Manager
Query) 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 [email protected]
Details Contact Person (Public Query)
Name Dr Balaji More
Details Contact Designation Senior General Manager
Person (Public Query) 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

page 1 / 9
 Phone
Fax
Email [email protected]
Source of Monetary or Source of Monetary or Material Support
Material Support > Cadila Healthcare Limited, Zydus Research Center, Survey No. 396/403, Sarkhej-Bavla National
Highway No.8A Moraiya, Ahmedabad - 382213
Primary Sponsor Details
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
Name Address
Details of Secondary NIL NIL
Sponsor
List of Countries
Countries of India
Recruitment Name of Principal Name of Site Site Address Phone/Fax/Email
Investigator
Sites of Study
Dr Sandeep Kumar atharva multi H-4/Comm-2, 9336077839
Gupta specialityhospitl and Constuction Div -21, , UP
research centre Avas Vikas Parishad, sandeepkumar.gupta@
Sector E, Lucknow , Uttar rediffmail.com
Pradesh - 226003 India
Lucknow
UTTAR PRADESH

Dr Sunil Wanve BAJ RR Hospital P 14 M.I.D.C. Phase I, 9820328503

Research Centre Milap Nagar, Dombivali
East Maharashtra India drsunilwanve52@gmail.
421203 com
Thane
MAHARASHTRA
Dr Koradia Parshottam BAPS Pramukh Swami Shri Pramukh Swami 9825312027
Govindbhai Hospital Maharaj Marg Adajan
Char Road Adajan purushottam_koradia@
Surat 395009 Gujarat yahoo.co.in
India
Surat
GUJARAT
Dr Sisir Chakraborty College of Medicine & 578 , BT Road, 8240565690
Sagore Dutta Hospital Kamahati, Kolkata
700058 - India chakrabortysisir@yaho
Kolkata o.co.in
WEST BENGAL
Dr Mahamine Kaustubh Dr. Vasantrao Pawar 4th Floor Near MRD 7506117341
Suryakant Centre for Development Section in Medical
Therapeutics translation College, Dr. Vasanatrao drkaustubhmahamine@
Research Pawar Medical College, gmail.com
Hospital and Research
Centre, Vasantdada Nagar,
Adgaon, Nashik
– 422003 , Maharashta,
India
Nashik
MAHARASHTRA
Dr Nikhil Verma ESIC Medical College NH - 3 NIT Behind BK 7000798104
and Hospital Hospital, Faridabad
Haryana - 121001 New [email protected]
Delhi
DELHI
Dr Manoj Kumar Singh Flores Hospital Block G, Sector 11, 7877110499
Pratap Vihar Ghaziabad
New Delhi drmanoj73kumar@gmai
DELHI l.com
Dr Nischal Yalgi Global Hospital & 577/2 off Sinhgad Road, 9168764422
Research Institute Near Dattawadi Police
Chowki, Dattawadi, [email protected]
Pune – 411030 om
Maharashtra India
Pune
MAHARASHTRA

Dr Parul Bhatt GMERS Medical Department of Medicine 9879599595

college and Civil GMERS Medical college
Hospital and Civil Hospital, Sola [email protected] m
Nr Gujarat High Court, S
G Highway, Sola
Ahmedabad, Gujarat –
380060, India
Ahmadabad
GUJARAT

Dr Saurabh Agarwal GSVM Medical College, Department of Medicine 9415039582

GSVM Medical College,
Swaroop Nagar, Kanpur saurabh.gsvmmed@gm
– 208002 Uttar Pradesh ail.com
Kanpur Nagar
UTTAR PRADESH

Dr Rajnish Nagarkar HCG Manavata Cancer HCG Manavata Cancer 9823061929

Centre Centre Behind Shivang
Auto, Mumbai Naka, drraj@manavatacancer
Nashik-422002 centre.com
Maharashtra, India
Nashik
MAHARASHTRA
Dr Archana Mallareddy Narayana Suraram X Roads, 7729971707
Andhavarapu Multispeciality Hospital Jeedimetla, Hyderabad,
Telangana 500055 andhavarapuarchana@
Hyderabad gmail.com
TELANGANA
Dr Tanmay Medical Super 127, Mukundapur, E.M. 9433427474
Bandyopadhyay Specialty Hospital By pass, Kolkata –
700099 tanmay.banerjee@medi
Kolkata casynergie.in
WEST BENGAL
Dr Pravin Soni PGI Yashwantrao PCMC’S PGI 9822057511
Chavan Memorial Yashwantrao Chavan
Hospital Memorial Hospital Sant drpravinsoni18@gmail.
Tukaram Nagar Pimpri, com
Pune – 411018
Pune
MAHARASHTRA
Dr Nirav Bhalani Rhythm Heart Institute Near Siddharth 8128995863
 Bungalows, Sama Savli
Road, Vadodara – 390022 drniravbhalani@hotmail
Gujarat, India Vadodara .com
GUJARAT

Dr Vinay Bhomia Sanjivani Super 1, Uday Park Society, Nr. 9825007385

Speciality Hospital Pvt. Sunrise Park, Vastrapur,
Ltd Ahmedabad [email protected]
– 380015, Gujarat India om
Ahmadabad
GUJARAT
Dr Akash Khobragade St. George’s Hospital First Floor,Medical 9702658822
Superintendent Office,
St. George’s Hospital, P akash.khobragade@gm
D’Mello Road, Behind ail.com
GPO, Fort, Mumbai-
400001.
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA
Dr Arti Shah Sumandeep Vidyapeeth Department of Respiratory 9925047880
Institute Medicine Sumandeep
Vidyapeeth an Institute [email protected]
Deemed to be University m
& Dhiraj Hospital At. &
Po.
Piparia - Ta. Waghodia
Vadodara-391760
Vadodara
GUJARAT
Dr Divyang Dalwadi Tapan Research Centre Basement Tapan Hospital 9909913087
Near Platinum Hall
Anandnagar Cross Road [email protected]
Satellite, Ahmedabad – m
380015 Gujarat, India
Ahmadabad
GUJARAT

Dr Shashi Bhushan B L Victoria Hospital B - Block Ground Floor 9448239644

Victoria Hospital
Bangalore Medical shashibhushanbl@yaho
College and Research o.com
Institute Fort K R Road
Bangalore Urban
Karnataka 560002 India
Bangalore
KARNATAKA
Name of Committee Approval Status Date of Approval Is Independent Ethics
Details of Ethics
Committee?
Committee
" Altezza Institutional Approved 03/02/2021 No
Ethics Committee, Shree
Ashirwad Hospital C/3
Shree Complex Opposite
Mahavir Road,Manpada
Road Dombivli Thane
Maharashtra - 421201
India"
" INSTITUTIONAL Approved 10/02/2021 No
ETHICS COMMITTEE ,
GGMC, MUMBAI Grant
Govt Medical College,
JJ Road, JJ Hospital
compound Mumbai
Central Mumbai
Mumbai City
Maharashtra - 400008
India "
"Institutional Ethics Approved 28/01/2021 No
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"

BAPS Hospital Approved 15/12/2020 No

Institutional Ethics
Committee BAPS
Pramukh Swami Hospital
BAPS Pramukh Swami
Hospital Adajan Cross
Road, Adajan Surat Surat
Gujarat - 395009 India

Clinical Research Ethics Approved 20/01/2021 No

committee Medical Super
Specialty Hospital 127,
Mukundapur, E.M. By
pass, Kolkata – 700099

Ethics Committe GSVM Approved 31/12/2020 No

Medical College,
Swaroop Nagar, Kanpur
– 208002 Uttar Pradesh

Ethics Committee Of Approved 04/01/2021 No

BMCRI Bangalore
Medical College And
Research Institute Fort K
R Road Bengaluru Urban
Karnataka 560002 India

IEC for atharva multi Approved 22/12/2020 No

specialityhospitl and
research centre,
H-4/Comm-2,
Constuction Div -21, ,
UP Avas Vikas
Parishad, Sector E,
Lucknow , Uttar
Pradesh - 226003 India
IEC, Dr. Vasantrao Approved 08/01/2021 No
Pawar Medical College,
Dr. Vasanatrao Pawar
Medical College, Hospital
and Research Centre,
Vasantdada Nagar,
Adgaon, Nashik
Maharashtra - 422003
India
Institutional Ethics Approved 30/12/2020 No
Committee SV,
Sumandeep Vidyapeeth At
& Post. Piparia - Ta.
Waghodia
Vadodara-391760
Institutional Ethics Approved 11/01/2021 No
Committee College of
Medicine & Sagore Dutta
Hospital Office of
Pricipal, 578 , BT Road,
Kamarhati, Kolkata
700058 - India
Institutional Ethics Approved 15/12/2020 No
Committee for Sehgal
Nursing Home Sehgal
Nursing Home, A 6
Panchwati , opp
Azadpur New Sabzi
Mandi - Delhi 110033
Institutional Ethics Approved 15/12/2020 No
Committee for Sehgal
Nursing Home Sehgal
Nursing Home, A 6
Panchwati , opp
Azadpur New Sabzi
Mandi - Delhi 110033
Institutional Ethics Approved 05/01/2021 No
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
Institutional Ethics Approved 12/01/2021 No
Committee Malla Reddy
Medical College For
Women Suraram X Road
Qutbullapur, Municipality,
Jeedimetla Hyderabad
Telangana - 500055 India

Institutional Ethics Approved 17/12/2020 No

Committee Sai Sneh
Hospital and Daignostic
Centre Opp. PMT Bus
Depot Pune Satara
 Road Katraj Pune
Maharashtra - 411046
India
Manavata Clinical Approved 29/12/2020 No
Research Institute Ethics
Committee HCG
Manavata Cancer Centre
Behind Shivang Auto,
Mumbai Naka, Nashik ,
Maharashtra– 422002
India
Rhythm Heart Institute Approved 24/12/2020 No
Ethics Committee
Rhythm Heart Institute
Near Siddharth Bunglows
Sama- Savli Road
Vadodara Gujarat
– 390022
Sanjivani Super Approved 15/12/2020 No
Speciality Hospital Pvt.
Ltd 1, Uday Park
Society, Nr. Sunrise
Park, Vastrapur,
Ahmedabad – 380015,
Gujarat India
Vrajesh Hospital Approved 14/12/2020 No
Institutional Review
Board Shree Vrajesh
Surgical Hospital
Opposite Rajpath Club
Cargo Motors lane,
S.G. road, 117 Bodakdev
Ahmedabad Gujarat -
380015

Regulatory Clearance Status Date

Status from DCGI Approved/Obtained 14/12/2020
Health Type Condition
Health Condition /
Patients Coronavirus as the cause of diseases classified
Problems Studied
elsewhere
Type Name Details
Intervention / Intervention Pegylated IFN-?2b and Single dose of Pegylated IFN-
Comparator Agent Standard of care ?2b (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
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.<br/> 2. Male or non-pregnant females, ?18 years of age at the time
of enrolment.<br/> 3. Understands and agrees to comply with planned study
procedures.<br/> 4. Agrees to the collection of pharyngeal swabs and blood
sample as per protocol.<br/> 5. Has laboratory-confirmed SARS-CoV-2
infection as determined by
 RT-PCR within 5 days of<br/> enrollment.<br/> 6. Patients with
pneumonia with no signs of severe disease, respiratory rate
?24breaths/minute,<br/> SpO2 90%- 94%.<br/> 7. Illness of any duration,
and at least one of the following:<br/> a. Radiographic infiltrates by
imaging (chest x-ray/CT scan)<br/> b. Clinical assessment (evidence of
rales/crackles or other clinical symptoms related to COVID-19 on
examination).<br/> 8. Women of childbearing potential must agree to use
at least one primary form of contraception<br/> for the entire duration of
the study (acceptable methods will be determined by the site).

Exclusion Criteria Exclusion Criteria

Details 1. ALT/AST >5 times the upper limit of normal.
2. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR
450 ms).

Method of Generating Computer generated randomization

Random Sequence
Method of Not Applicable
Concealment
Open Label
Blinding/Masking
Primary Outcome Outcome Timepoints
Evaluation of the clinical efficacy of Pegylated baseline to Day 11
interferon alfa-2b on the basis of change in ordinal
scale at Day 11 ± 1.

Outcome Timepoints
Secondary Outcome
Evaluation of the clinical efficacy of Pegylated screening to Day 8, Day 11 and Day 15.
interferon alfa-2b on the basis of change in ordinal
scale
Proportion of subjects who are found negative to screening to Day 7, Day 11and Day 15
SARS-CoV-2 based on Qualitative and Quantitative
(Based on the CT value) RT-PCR.
Occurrence and duration (days) of supplemental Screening to Day 15
oxygen.
Occurrence and duration (days) of mechanical Screening to Day 15
ventilation.
Time to resolution of clinical signs and Screening to Day 15
symptoms.
Incidence of adverse events and serious adverse Screening to Day 15 and Day 29
events.
Duration of hospitalization. Screening to Day 15
Change in white blood cell count, haemoglobin, screening to Day 3, Day 7, Day 15
platelets, creatinine, glucose, total bilirubin, ALT,
and AST
Change in C-reactive protein, IL-6, D-dimer and screening to Day 3, Day 7 and
Ferritin Day 15.
Total Sample Size=250
Sample Size from India=250
Target Sample Size Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials
Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials
Phase 3
17/12/2020
Phase of Trial
Date of First No Date Specified
Enrollment (India)
Date of First
Enrollment (Global)
Estimated Duration of Years=0
Trial Months=10
Days=0
Recruitment Status of Not Applicable
Trial (Global)
Recruitment Status of Closed to Recruitment of Participants
Trial (India)
Publication Details NIL
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.