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CTRI Number  CTRI/2020/06/025957 [Registered on: 17/06/2020] Trial Registered Prospectively
Last Modified On: 14/09/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical Study on Favipiravir and Umifenovir Compared to Favipiravir alone in Hospitalized Patients with Moderate COVID-19. 
Scientific Title of Study   A Randomized Open-Label Study To Evaluate The Efficacy And Safety Of Favipiravir And Umifenovir As Compared To Favipiravir Alone In Moderate Hospitalized Adult Indian COVID-19 Patients. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
GPL/CT/2020/004/III, Version:4.0, Dated:03-Jun-2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
 
Name  Dr Pawan Singh 
Designation  DGM-Clinical Development  
Affiliation  Glenmark Pharmaceuticals Ltd 
Address  Glenmark Pharmaceuticals Ltd, Glenmark House, B D Sawant Marg, Chakala, Andheri East

Mumbai
MAHARASHTRA
400099
India 
Phone  02250451200  
Fax    
Email  Pawan.Singh@glenmarkpharma.com  
 
Details of Contact Person
Public Query
 
Name  Amol Pendse 
Designation  DGM-Clinical Research Operations 
Affiliation  Glenmark Pharmaceuticals Ltd 
Address  Glenmark Research Centre, Plot No. A-607, T.T.C. Industrial Area,MIDC, Mahape, Navi Mumbai

Thane
MAHARASHTRA
400709
India 
Phone  02250451200  
Fax    
Email  Amol.Pendse@glenmarkpharma.com  
 
Source of Monetary or Material Support  
Glenmark Pharmaceuticals Ltd., Glenmark House, B.D. Sawant Marg, Chakala, Andheri East, Mumbai State: Maharashtra PIN Code: 400099 
 
Primary Sponsor  
Name  Glenmark Pharmaceuticals Ltd 
Address  Glenmark House, B.D. Sawant Marg, Chakala, Andheri East, Mumbai, State: Maharashtra PIN Code: 400099 
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 Rajashree Khot  All India Institue of Medical Sciences-Nagpur   Covid 19 ward, 5th floor OPD complex, MIHAN, Sumthana, Nagpur-441108
Nagpur
MAHARASHTRA 
9823134598

rajashree.s.khot@gmail.com 
Dr Atul Jindal  All India Institue of Medical Sciences-Raipur  Covid Ward, Ayush Building Gate No.01, Department of Pediatric Medicine, Room No.1111, First Floor, G.E Road Tatibandh Raipur-492099
Raipur
CHHATTISGARH 
8224014667

dratuljindal@gmail.com 
Dr Krishnamoorthy  Apollo Speciality Hospitals  Plot no. 64, Vanagaram, Vanagaram-Ambattur Rd, Ayanambakkam, Pin: 600095
Chennai
TAMIL NADU 
9443330699

drmoorthykrishnan@yahoo.co.in 
Dr Jayanthi CR  Bangalore Medical College and Research Institute  Covid Isolation ward Trauma care center, Fort KR Road, Bengaluru,560002
Bangalore
KARNATAKA 
9448292424

bmccrj@gmail.com 
Dr Abhay Uppe  D Y Patil Hospital  Isolation ward: E wing - 2,3,4 floor and D wing - 6,7 floor, Sector – 5, Navi Mumbai 400 706
Thane
MAHARASHTRA 
9769319554

abhay.uppe@dypatil.edu 
Dr Shalini Surulkar  Dr LH Hiranandani Hospital  COVID ward, 4&5th floor, Research room seventh floor, Hillside Avenue, Hirandndani Gardens, Powai-400076
Mumbai (Suburban)
MAHARASHTRA 
9819426036

shalini.suralkar@hiranandanihospital.org 
Dr Chirag Rathod  GMERS Hospital  Covid Isolation Block, Clinical Study Room, 6th Floor, Department of Medicine, Gotri, Vadodara - 390021
Vadodara
GUJARAT 
9909035630

Chirag.rhtd@rediffmail.com 
Dr Meenakshi Bhattacharya  Government medical college and hospital-Aurangabad  COVID Ward No 06, Third floor, Department of Medicine, Near Makkai Gate, Panchakki Road, Aurangabad- 431001
Aurangabad
MAHARASHTRA 
9922931527

meenakshi.medicine@gmail.com 
Dr Rajesh Gosavi  Government Medical College and Hospital-Nagpur  COVID Hospital and Critical Care Management,Government Medical College and Hospital,Hanuman Nagar, Department of medicine, Research room, Second Floor, Medical Square Road, Nagpur-440003
Nagpur
MAHARASHTRA 
9890225111

gosavirv@hotmail.com 
Dr Rajesh Chawala  Indraprastha Apollo Hospital  Covid Isolation ward, Gate no.10, Third Floor, Sarita Vihar, Mathura Road, New Delhi 110076
South
DELHI 
9810033395

drchawla@hotmail.com 
Dr Chirag Chatwani  Metas Adventist Hospital  Covid Isolation wards:M6, M7, and M8, B wing, Nondh no 0363 to 0365, RS no21,Main Road, Athwalines City Surat-395001
Surat
GUJARAT 
9913224898

dr.chiragchhatwani@gmail.com 
Dr Anand Nikalje  MGM medical College & Hospital  Covid Ward, Basement, Building B,Clinical Research Unit, 3rd Floor, Building A,N-6, Cidco, Aurangabad-431003
Aurangabad
MAHARASHTRA 
9822496190

dranandnikalje68@gmail.com 
Dr Ameet Dravid  Noble Hospitals Pvt. Ltd  Covid Building, ,Room No 5, Clinical Research Department Noble Annex, 153 A, Magarpatta City Road, Hadapsar, Pin: 411013
Pune
MAHARASHTRA 
9975619766

ameet.dravid@gmail.com 
Dr Mahesh More  Rajiv Gandhi Medical College & Chatrapati Shivaji Maharaj Hospital  Old Thane Belapur Road, Kalwa, Thane 400065
Thane
MAHARASHTRA 
9819938101

maheshmore007@gmail.com 
Dr Amlendu Yadav  Ram Manohar Lohia Hospital  Covid Ward Room No. 202, Trauma Buidling, Critical care unit, Type III, Connaught Place, New Delhi-110001
New Delhi
DELHI 
9711315438

yadavamlendu@gmail.com 
Dr Kapil Zirpe  Ruby Hall Hospital  Covid Isolation ward and IP room, Sangvi Building, Building no.2, 3rd floor, 40 Sassoon road, Pune-411001
Pune
MAHARASHTRA 
9822844212

kapilzirpe@gmail.com 
Dr Varun Gavali  Seth Nandlal Dhoot Hospital   Covid Isolation ward/room/ICU, A-1, MIDC, Chikalthana, Jalna road, Aurangabad 431210
Aurangabad
MAHARASHTRA 
9049398835

drvarunlive@gmail.com 
Dr Shreepad Bhatt  Smt. Kashibai Navale Medical College & General Hospital  Covid Isolation ward, Fourth & Fifth floor, Department of Medicine, S.No.49/1, Narhe off Pune Mumbai Bypass, Pune 411041
Pune
MAHARASHTRA 
9422364536

smb.med@gmail.com 
Dr Priti Meshram  St. George Hospital  Critical care covid center/ Research Department, First floor,Near superidentants office,PDmello road, CST, Mumbai 400001
Mumbai
MAHARASHTRA 
9323198298

drpritimeshram@gmail.com 
Dr Pravin Soni  Yashwantrao Chavan Memorial Hospital  Covid Isolation ward, Main building ground, First, Fourth, & Fifth floor, Sant Tukaram Nagar, Pimpri Pune 411018
Pune
MAHARASHTRA 
9822057511

drpravinsoni18@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 20  
Name of Committee  Approval Status 
Ethics Committee - Metas Adventist Hospital   Approved 
Ethics Committee Of Bangalore Medical College and Research Institute  Approved 
Insititutional Ethics Committee department of Pharmacology-Govt Medical College Nagpur  Approved 
Institutional Ethics Commiitee, Rajiv Gandhi Medical College and Chatrapati Shivaji Maharaj Hospital  Approved 
Institutional Ethics Committee for Clinical Trials-AIIMS Nagpur  Approved 
Institutional Ethics Committee, ABVIMS, Dr. RML Hospital  Approved 
Institutional Ethics Committee, AIIMS Raipur  Approved 
Institutional Ethics Committee, D Y Patil Medical College  Approved 
Institutional Ethics Committee, DY Patil Medical College  Approved 
Institutional Ethics Committee, Government Medical College Aurangabad  Approved 
Institutional Ethics Committee, Smt.Kashibai Navale Medical College and General Hospital  Approved 
Institutional Ethics Committee, Yashwantrao Chavan Memorial Hospital  Approved 
Institutional Ethics Committee- Clinical Studies Apollo Hospitals  Approved 
Institutional Ethics Committee- Poona Medical Research Foundation  Approved 
Institutional Ethics Committee-Clinical Studies Indraprastha Apollo Hospital  Approved 
Institutional Ethics Committee-Grant Government Medical College & Sir J J Group of Hopsitals  Approved 
Institutional Human Ethics Committee-GMERS Medical College and Hospital  Approved 
Mahatma Gandhi Missions Ethics Committee for Research on Human Subjects  Approved 
Noble Hospital Institutional Ethics Committee  Approved 
Seth Nandlal Dhoot Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
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 
Comparator Agent  Favipiravir 200mg Tablets  Dosage Form: Tablets Dosage Frequency: 3,600 mg (1,800 mg BID) (Day 1) + 1,600 mg (800 mg BID) (Day 2 or later) for up to maximum of 14 days, Mode of Administration: Oral  
Intervention  Favipiravir 200mg Tablets  Dosage Form: Tablets, Dosage Frequency: 3,600 mg (1,800 mg BID) (Day 1) + 1,600 mg (800 mg BID) (Day 2 or later) for up to maximum of 14 days, Mode of Administration: Oral 
Intervention  Umifenovir capsules: 800 mg BID  Dosage Form: Capsule Dosage Frequency: 800 mg BID, Mode of Administration: Oral 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); willingness and capability to complete all the study procedures
2. Age > 18 years at the time of signing ICF
3. Patients with laboratory confirmation of infection with SARS-CoV-2 by positive RT-PCR (within 48 hours prior to randomization)
4. Radiographic evidence of pneumonia
5. Respiratory rate > 24 breaths per minute
6. Any two of the following signs or symptoms suggestive of COVID-19: cough/shortness of breath or difficulty in breathing/fever/chills/muscle pain/sore throat/new loss of taste or smell
7. Oxygen saturation (SpO2) ≤ 93 % on room air
8. Time interval between symptoms onset and randomization less than 10 days
9. Currently hospitalized and requiring medical care for COVID 19
10. For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative pretreatment serum pregnancy test
11. Eligible subjects of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period and for at least 7 days following the last study treatment;
12. Not participating in any other interventional drug clinical studies before completion of the present study.
 
 
ExclusionCriteria 
Details  Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely
Severe infection, defined as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support.
Severe respiratory distress and PaO2/FiO2 ≤ 300 mmHg
Inability to intake or tolerate oral medications.
Liver disease or alanine aminotransferase (ALT) /aspartate aminotransferase (AST) elevated over 5 times the ULN
Gout/history of gout or hyperuricemia (above the ULN)
Prolonged QT, defined as QTcF ≥450 milliseconds for men and as QTcF ≥470 for women
Known severely reduced LV function (ejection fraction <30%)
Heart rate ≥ 125 beats per minute
Requires ICU care for management of ongoing clinical status (respiratory failure, septic shock, and/or multiple organ dysfunction or failure).
Known allergy or hypersensitivity to favipiravir or umifenovir
Subject is using adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers
Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 < 24 hours prior to study drug dosing
Known severe renal impairment [creatinine clearance (CrCl) <30 mL/min] or having received continuous renal replacement therapy, hemodialysis or peritoneal dialysis;
Asthma or chronic obstructive lung disease
Psychiatric disease that is not well controlled (controlled defined as stable on a regimen for more than one year).
Pregnant or lactating women;
Having used favipiravir or umifenovir participated in any other interventional drug clinical study within 30 days prior to first dose of study drug.
Clinical prognostic non-survival or requirement of palliative care. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Time from randomization to clinical cure (defined as resolution of baseline clinical signs and symptoms of COVID-19 infection and at least 2 point improvement on WHO Ordinal Scale for Clinical Improvement) (Time frame-28 days).  Upto 28 days 
 
Secondary Outcome  
Outcome  TimePoints 
Rate of Clinical cure at day 4/7/10/14/28  On day 4/7/10/14 
Rate of SARS-CoV-2 RT-PCR negativity in both oropharyngeal swab and nasopharyngeal swab at day 4/7/10/14/28  On day 4/7/10/14 
Time from randomization to first time requirement of non- invasive ventilation/intubation/mechanical ventilation/ECMO  From randomization to first use of high flow
supplemental oxygen/non-invasive
ventilation/mechanical ventilation/ extracorporeal
membrane oxygenation (or day 28, which ever is
earlier) 
Time from randomization to hospital discharge  From randomization to hospital discharge (or day 28,
which ever is earlier) 
Rate of % improvement in radiological findings at discharge  at the time of discharge 
All-cause mortality rate at day 4/7/10/14/28  On day 4/7/10/14 
Frequency of serious adverse events  Randomization to hospital discharge (or day 28,
which ever is earlier) 
 
Target Sample Size   Total Sample Size="158"
Sample Size from India="158" 
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)   29/06/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Glenmark proposes to conduct the current study of favipiravir  and umifenovir in moderate hospitalized COVID-19 patients in India in line with global trials ongoing for this drug.

This is a phase 3, open label, randomized, multicentre study .The primary objective of this study is to evaluate the clinical efficacy of favipiravir and umifenovir combined with standard supportive care compared with favipiravir alone with standard supportive care alone. 158 eligible patients will be randomized in a 1:1 ratio. The randomization will be computer generated and treatment will be allocated centrally. The study includes 3 days of screening period and maximum 14 days of treatment period. The total duration of study participation will be a maximum of 28 days from the day of randomization.  
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