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
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Drug |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
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A Clinical Study on Favipiravir Compared to Standard Supportive Care in Patients With Mild to Moderate COVID-19. |
Scientific Title of Study
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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 |
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Secondary IDs if Any
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Secondary ID |
Identifier |
GPL/CT/2020/002/III, Version: 3.0, dated: 26 Apr 2020 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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Name |
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Designation |
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Affiliation |
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Address |
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Phone |
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Fax |
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Email |
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Details of Contact Person Scientific Query
Modification(s)
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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 |
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Email |
Pawan.Singh@glenmarkpharma.com |
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Details of Contact Person Public Query
Modification(s)
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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 |
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Email |
Amol.Pendse@glenmarkpharma.com |
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Source of Monetary or Material Support
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Glenmark Pharmaceuticals Ltd. |
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Primary Sponsor
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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 |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
Sites of Study
Modification(s)
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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 |
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Details of Ethics Committee
Modification(s)
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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 |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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Health Type |
Condition |
Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
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Intervention / Comparator Agent
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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
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Comparator Agent |
Standard Supportive Care |
These patients will be managed by standard supportive care. |
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Inclusion Criteria
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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.
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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. |
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Method of Generating Random Sequence
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Stratified randomization |
Method of Concealment
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Centralized |
Blinding/Masking
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Open Label |
Primary Outcome
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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 |
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Secondary Outcome
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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) |
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Target Sample Size
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Total Sample Size="150" Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
Phase of Trial
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Phase 3 |
Date of First Enrollment (India)
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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
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Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
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Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
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NIL |
Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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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. |