PDF of Trial CTRI Website URL

PDF of Trial CTRI Website URL - http://ctri.nic.in

Clinical Trial Details (PDF Generation Date :- Mon, 27 Sep 2021 22:46:06 GMT)

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 A phase II, randomized, controlled, open-label study to evaluate the efficacy and safety of Study Pegylated IFN alfa-2b in the treatment of adult patients diagnosed with SARS-CoV2 (COVID-19). Secondary IDs if Any Secondary ID Identifier PEGI.20.002,Version 3.12May2020 Protocol Number Details of Principal Details of Principal Investigator Investigator or overall Name Dr Kevinkumar Kansagra Trial Coordinator (multi-center study) 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 [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Kevinkumar Kansagra Query) 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 [email protected] Details Contact Details Contact Person (Public Query) 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

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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 Primary Sponsor Details 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 Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Anuja Pandit AIIMS Dept Of Onco 9710030457 Anaesthesia and Palliative Medicine, [email protected]. National Cancer in Institute, Jhajjar AIIMS, New Delhi New Delhi DELHI Dr Koradia Parshottam BAPSPramukhSwami ShriPramukhSwamiMa 9825312027 Govindbhai Hospital haraj Marg AdajanCharRoadAdaja purushottam_koradia@ n Surat 395009 Gujarat yahoo.co.in India Surat GUJARAT Dr Nirav Bhalani Rhythm Heart Institute Near Siddharth 8128995863 Bungalows, Sama Savli Road,Vadodara – drniravbhalani@hotmail 390022 Gujarat, India .com Vadodara GUJARAT Dr Vinay Bhomia Sanjivani Super 1, Uday park Society, 9825007385 Speciality Hospital Pvt. Nr. Sunrise Park, Ltd Vastrapur Ahmedabad [email protected] – 380015, Gujarat, om India Ahmadabad GUJARAT Dr Shweta Gargiya Tapan Research Centre Basement Tapan 963822666 Hospital Near Platinum Hall Anandnagar Cross [email protected] Road Satellite, om Ahmedabad – 380015 Gujarat, India Ahmadabad GUJARAT Dr Shashi Bhushan B L Victoria Hospital Fort K R Road 9448239644 Bangalore Medical Bangalore Urban

page 2 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in

College and Research Karnataka 560002 India shashibhushanbl@yaho Institute Bangalore o.com KARNATAKA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? BAPSPramukhSwamiH Approved 18/07/2020 No ospital InstitutionalEthic sCommittee BAPSPram ukhSwamiHospital Shri PramukhSwamiMaharaj Marg AdajanCharRoad AdajanSurat395009Guj aratIndia Ethics Committee Of Approved 29/07/2020 No BMCRI Bangalore Medical College And Research Institute Fort K R Road Bengaluru Urban Karnataka 560002 India IEC, AIIMS, Room No Approved 15/06/2020 No 102, 1st Floor Old OT Block, Ansari Nagar, New Delhi - 110029 Rhythm Heart Institute Approved 10/07/2020 No Ethics Committee Rhythm Heart Institute Near Siddharth Bunglows Sama- Savli Road Vadodara Gujarat – 390022 India Sanjivani Hospital Approved 14/07/2020 No Ethics Committee Sanjivani Super Speciality Hospital Pvt.Ltd. 1,Uday Park Society, Near Sunrise Park Vastrapur Vastrapur Ahmedabad Gujarat - 380015 India Vrajesh Hospital Approved 29/06/2020 No Institutional Review Board Shree Vrajesh Surgical Hospital Opposite Rajpath Club Cargo Motors lane, S.G. road, 117 Bodakdev Ahmedabad Gujarat - 380015 India Regulatory Clearance Status Date Status from DCGI Approved/Obtained 08/05/2020 Health Condition / Health Type Condition Problems Studied Patients Coronavirus as the cause of diseases classified elsewhere Intervention / Type Name Details Comparator Agent Comparator Agent NIL NIL

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Intervention Pegylated alpha 2b and Administer Day 1 and Day 8 Standard of care Route-Subcutaneous Inclusion Criteria 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). Exclusion Criteria Exclusion Criteria 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 Computer generated randomization Random Sequence Method of An Open list of random numbers Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints Evaluation of the clinical efficacy of Pegylated week 2 and week 4 IFN-?2b on the basis of change in ordinal scale. Secondary Outcome Outcome Timepoints 1) Qualitative and quantitative PCR for screening SARS-CoV-2 in pharyngeal swab. day, day 7 and day 14 2) Safety and tolerability 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 08/07/2020 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=4 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Completed Trial (India)

page 4 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in

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).

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