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CTRI Number  CTRI/2020/05/025114 [Registered on: 12/05/2020] Trial Registered Prospectively
Last Modified On: 27/07/2020
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 Compared to Standard Supportive Care in Patients With Mild to Moderate COVID-19. 
Scientific Title of Study   A Randomized, Open-label, multicenter study to evaluate the efficacy and safety of Favipiravir combined with STANDARD supportive care in adult Indian patients with mild to moderate COVID-19 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
GPL/CT/2020/002/III, Version: 3.0, dated: 26 Apr 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
Modification(s)  
Name  Dr Pawan Singh 
Designation  DGM Clinical Development Branded Generics 
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
Modification(s)  
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. 
 
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 = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Atul Jindal  AIIMS  Covid Ward , Ayush Building Gate No.01, Department of Pediatric Medicine, Room No.1111, First Floor ,Medical College Complex, Gate no.05,AIIMS, G.E Road Tatibandh Raipur 492099
Raipur
CHHATTISGARH 		 07712572240

dratuljindal@gmail.com 
Dr Zarir Udwadia  Breach Candy Hospital Trust  60-A, Bhulbhai Desai Road, Mumbai 400026
Mumbai
MAHARASHTRA 		 02223667788

zfudwadia@gmail.com 
Dr Abdul Ansari  Dr. Balabhai Nanavati Hospital  SV Rd, Suresh Colony, Vile Parle West, Mumbai-400056
Mumbai
MAHARASHTRA 		 02226267500

abdul.ansari@nanavatihospital.org 
Dr Anita Mathews  Fortis Hospital Limited  Level 7, Signature floor, Mulund Goregaon Link Road, Bhandup west Mumbai 400078
Mumbai
MAHARASHTRA 		 09606047050

jojosanish@gmail.com 
Dr Chirag Rathod  GMERS Medical college & Hospital  Gotri, Vadodara -390021
Vadodara
GUJARAT 		 02652398008

chirag_rthd@rediffmail.com 
Dr Meenakshi Bhattacharya  Government medical college and hospital  COVID Ward No 06,third floor, Research room, Second floor, Department of Medicine, Near Makkai Gate, Government Medical College & Hospital, Panchakki Road, Aurangabad- 431001
Aurangabad
MAHARASHTRA 		 02402402412

mabhattacharya@gmail.com 
Dr Rajesh Gosavi  Government medical college and hospital   COVID Hospital and Critical Care Management, Department of medicine, Research room, Second floor, Hanuman Nagar, Ajni Rd, Medical Square Road, Nagpur- 440003
Nagpur
MAHARASHTRA 		 07122743588

gosavirv@hotmail.com 
Dr Urman Dhruv  HCG Hospital  Covid Ward at 3rd , 6th & 10th Floor, 4th Floor, Clinical Research Department, Mithakhali six roads, Ellisbridge, Ahmedabad- 380006
Ahmadabad
GUJARAT 		 07940010101

drurmandhruv@hotmail.com 
Dr Chandrakant Pawar  Kasturba Hospital for Infectious Disease   Sane Guruji Marg, Arya Nagar, Chinchpokli, Mumbai-400034
Mumbai
MAHARASHTRA 		 02223027700

drcppawar@yahoo.in 
Dr Tanu Singhal  Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute  Achutrao Patwardhan Marg, Four Bunglows, Andheri (West), Mumbai- 400053
Mumbai
MAHARASHTRA 		 02230696969

Tanu.Singhal@relianceada.com 
Dr R S Mishra  Max Smart Super Speciality Hospital   Mandir Marg, Press enclave Road, Saket, New Delhi- 110017
South
DELHI 		 01171212121

docmishra@yahoo.co.in 
Dr Keyur Madan Brahme  SSG Hospital & Medical College Baroda  Covid 19 Isolation block, Jail road, (Indira Avenue), Vadodara-390001, Gujarat
Vadodara
GUJARAT 		 912652421594

keyurbrahme@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
Ethics Committee Jaslok Hospital and Research Center   Approved 
Ethics Committee, Dr. Balabhai Nanavati Hospital  Approved 
Ethics Committee, Breach Candy Medical Research Centre  Approved 
HCG Multi Specialty Ethics Committee  Approved 
Institutional Ethics Committee for Human Research, Medical College Baroda & SSG Hospital   Approved 
Institutional Ethics Committee of Fortis Hospitals Limited  Approved 
Institutional Ethics Committee, Departmnet of Pharmacology, Govt Medical College Nagpur  Approved 
Institutional Ethics Committee, Government Medical College Aurangabad  Approved 
Institutional Ethics Committee, Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute  Approved 
Institutional Ethics Committee-AIIMS  Approved 
Institutional Human Ethics Committee, GMERS Medical College & General hospital  Approved 
Max Healthcare Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
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 
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  
Comparator Agent  Standard Supportive Care  These patients will be managed by standard supportive care. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 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.
Age 18-75 years (inclusive) at the time of signing ICF.
Patients with laboratory confirmation of infection with SARS-CoV-2 by positive RT-PCR (within 48 hours prior to randomization).
For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative pretreatment serum or urine pregnancy test.
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.
Not participating in any other interventional drug clinical studies before completion of the present study.
Additional Inclusion criteria for mild cases only:
Time interval between symptoms onset and randomization to no more than 7 days.
Pyrexia (temperature < 102.2oF); respiratory rate 12 to ≤20/min.
No more than four of the following of mild severity, and no more than two of moderate severity (Mild is defined as symptoms not requiring any or minimal therapeutic intervention; moderate is defined as symptoms which produce small impairment of function and require some form of therapeutic intervention; severe is defined as symptoms resulting in marked impairment of function):
Cough
Sore throat
Headache
Nasal congestion
Body aches and pains
Fatigue
Additional Inclusion criteria for moderate cases:
Patients with the interval between symptoms onset and randomization is no more than 10 days
Chest imaging (CT as first option or X-ray if CT not possible)-documented pneumonia
Patients with pyrexia (axillary ≥ 98.6°F or oral ≥ 99.5°F); respiratory rate > 20 to < 30/min.

 
 
ExclusionCriteria 
Details  Subjects meeting any of the following criteria must not be enrolled in the study:
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.
Inability to intake or tolerate oral medications.
Severe liver disease: underlying liver cirrhosis 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 %).
Oxygen saturation (SPO2) ≤ 93 % or arterial oxygen partial pressure (PaO2)/ fraction of inspired O2 (FiO2)≤ 300 mmHg;
Requires ICU care for management of ongoing clinical status.
Known allergy or hypersensitivity to Favipiravir;
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 participated in any other interventional drug clinical study within 30 days prior to first dose of study drug.
Clinical prognostic non-survival, palliative care, and have no response to supportive treatment within three hours of admission. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Time until cessation of oral shedding of SARS-CoV-2 virus [ Time Frame: Up to 28 days ] (Time in days from randomization to a negative SARS-CoV2 RT-PCR result of both oropharyngeal swab and nasopharyngeal swab).  Up to 28 days 
 
Secondary Outcome  
Outcome  TimePoints 
Time from randomization to clinical cure based on clinician assessment (Recovery of fever, respiratory rate, oxygen saturation and cough relief that is maintained for at least 72 hours; defined as(axillary temperature ≤ 97.8°F; respiratory rate ≤ 20 times/min; Oxygen saturation ≥ 98% without oxygen supplementation; mild or no cough) [For those patients who presented with clinical signs and symptoms at baseline]  From randomization to clinical cure (or day 28; whichever is earlier) 
Rate of Clinical cure at day 4/7/10/14  On day 4/7/10/14 
Rate of SARS-CoV2 RT-PCR negativity in both oropharyngeal swab and nasopharyngeal swab at day 4/7/10/14  On day 4/7/10/14 
Time from randomization to first time use of high flow supplemental oxygen/non-invasive ventilation/mechanical ventilation/ extracorporeal membrane oxygenation  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  Randomization to hospital discharge (or day 28, which ever is earlier) 
Frequency of serious adverse events  Randomization to hospital discharge (or day 28, which ever is earlier) 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   20/05/2020 
Date of Study Completion (India) 15/06/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  in mild to moderate 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 combined with standard supportive care compared with standard supportive care alone. 150 eligible patients will be randomized in a 1:1 ratio The randomization will be stratified based on baseline disease severity. 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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