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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
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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
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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
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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"
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" 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
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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
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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 Condition / Health Type Condition Problems Studied Patients Coronavirus as the cause of diseases classified elsewhere Intervention / Type Name Details Comparator Agent Intervention Pegylated IFN-?2b and Single dose of Pegylated IFN- 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.
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
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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). 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 Blinding/Masking Open Label 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. Secondary Outcome Outcome Timepoints 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. 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 17/12/2020 Enrollment (India) Date of First No Date Specified Enrollment (Global)
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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.
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