Covid Isolation Block, Clinical Study Room, 6th Floor, Department of Medicine, Gotri, Vadodara - 390021 Vadodara GUJARAT
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
Dr Rajesh Gosavi
Government Medical College and Hospital-Nagpur
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
Dr Rajesh Chawala
Indraprastha Apollo Hospital
Covid Isolation ward, Gate no.10, Third Floor, Sarita Vihar, Mathura Road, New Delhi 110076 South DELHI
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
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
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
Dr Mahesh More
Rajiv Gandhi Medical College & Chatrapati Shivaji Maharaj Hospital
Old Thane Belapur Road, Kalwa, Thane 400065 Thane MAHARASHTRA
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
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
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.
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
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
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
ventilation/mechanical ventilation/ extracorporeal
membrane oxygenation (or day 28, which ever is
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)= "158" Final Enrollment numbers achieved (India)="158"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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.