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Clinical Trial Details (PDF Generation Date :- Tue, 07 Sep 2021 08 PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Wed, 29 Sep 2021 20:12:22 GMT) 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 A Phase III, Randomized, Controlled, Open-Label Study to Evaluate the Efficacy and Safety of Study Pegylated Interferon Alfa-2b In the Treatment of Adult Patients Diagnosed With SARS-CoV-2 (COVID-19). Secondary IDs if Any Secondary ID Identifier PEGI.20.005 Versoion 02,02 December 2020 Protocol Number Details of Principal Details of Principal Investigator Investigator or overall Name Dr Manjunath K 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, Ahmedabad - 382213 Ahmadabad GUJARAT 382213 India Phone Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Kevinkumar Kansagra Query) 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 [email protected] Details Contact Details Contact Person (Public Query) 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 page 1 / 9 PDF of Trial CTRI Website URL - http://ctri.nic.in 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 Primary Sponsor Details 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 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 Sandeep Kumar atharva multi H-4/Comm-2, 9336077839 Gupta specialityhospitl and Constuction Div -21, , research centre UP Avas Vikas sandeepkumar.gupta@ Parishad, Sector E, rediffmail.com Lucknow , Uttar 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 page 2 / 9 PDF of Trial CTRI Website URL - http://ctri.nic.in Dr Nikhil Verma ESIC Medical College NH - 3 NIT Behind BK 7000798104 and Hospital Hospital, Faridabad Haryana - 121001 [email protected] New 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 9168764422 Research Institute Road, Near Dattawadi Police Chowki, [email protected] Dattawadi, Pune – om 411030 Maharashtra India Pune MAHARASHTRA Dr Parul Bhatt GMERS Medical Department of Medicine 9879599595 college and Civil GMERS Medical Hospital college and Civil [email protected] Hospital, Sola Nr m 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, saurabh.gsvmmed@gm Kanpur – 208002 Uttar ail.com Pradesh 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 page 3 / 9 PDF of Trial CTRI Website URL - http://ctri.nic.in 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 India om Ahmadabad GUJARAT Dr Akash Khobragade St. George’s Hospital First Floor,Medical 9702658822 Superintendent Office, St. George’s Hospital, akash.khobragade@gm P D’Mello Road, ail.com Behind GPO, Fort, Mumbai-400001. Mumbai MAHARASHTRA Mumbai MAHARASHTRA Dr Arti Shah Sumandeep Vidyapeeth Department of 9925047880 Institute Respiratory Medicine Sumandeep Vidyapeeth [email protected] an Institute Deemed to m be University & Dhiraj Hospital At. & Po. Piparia - Ta. Waghodia Vadodara-391760 Vadodara GUJARAT Dr Divyang Dalwadi Tapan Research Centre Basement Tapan 9909913087 Hospital Near Platinum Hall Anandnagar Cross [email protected] Road Satellite, m Ahmedabad – 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 Details of Ethics Name of Committee Approval Status Date of Approval Is Independent 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" page 4 / 9 PDF of Trial CTRI Website URL - http://ctri.nic.in " 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 Approved 20/01/2021 No Ethics 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 page 5 / 9 PDF of Trial CTRI Website URL - http://ctri.nic.in 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
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