CTRI/2020/11/029263 [Registered on: 20/11/2020] Trial Registered Prospectively
Last Modified On:
08/06/2022
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
A clinical study on Favipiravir in mild to moderate COVID-19 patients
Scientific Title of Study
Prospective, Open label, Multicentre, Single Arm, Post Marketing study for evaluation of safety and efficacy of Favipiravir in Adult Indian Patients with Mild to Moderate COVID-19 disease
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
GPL/CT/2020/007/IV Version 2.0 dated 26-Jun-20
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Saiprasad Patil
Designation
DGM- Global Medical Affairs
Affiliation
Glenmark Pharmaceuticals Ltd.
Address
Glenmark Corporate Enclave, B D Sawant Marg, Off Western Express Highway, Chakala, Andheri East, Mumbai- 400099
Mumbai (Suburban) MAHARASHTRA 400099 India
Phone
Fax
Email
Saiprasad.Patil@glenmarkpharma.com
Details of Contact Person Scientific Query
Name
Dr Saiprasad Patil
Designation
DGM- Global Medical Affairs
Affiliation
Glenmark Pharmaceuticals Ltd.
Address
Glenmark Corporate Enclave, B D Sawant Marg, Off Western Express Highway, Chakala, Andheri East, Mumbai- 400099
Nashik MAHARASHTRA 400099 India
Phone
Fax
Email
Saiprasad.Patil@glenmarkpharma.com
Details of Contact Person Public Query
Name
Rajesh Gaikwad
Designation
Senior Manager- Clinical Research Operations
Affiliation
Glenmark Pharmaceuticals Ltd.
Address
Glenmark Research Centre, A-607, MIDC Mahape, Navi Mumbai
Mumbai MAHARASHTRA 400709 India
Phone
Fax
Email
Rajesh.Gaikwad@glenmarkpharma.com
Source of Monetary or Material Support
Glenmark Pharmaceuticals Ltd.
B D Sawant Marg, Off WE highway, Andheri East, Mumbai- 400099
Aster Prime Hospital, Opp. Passport Seva Kendra, Ameerpet, Hyderabad- 500038, Telangana, India Hyderabad TELANGANA
9848883444
nagaraj.boyilla@gmail.com
Dr Pavan Kumar Reddy
Care Hospital
Room No. 217, Department of Critical Care medicine, Care Hospital, Road no. 1, Banjara Hills, Hyderabad-500034. Hyderabad TELANGANA
9490480182
pakure@gmail.com
Dr Ravindra Shinde
Dr Vasantrao Pawar Medical College, Hospital and Research Center
Dr Vasantrao Pawar Medical College, Hospital and Research Center,
Mumbai-Agra National Highway, Vasantdada Nagar,
Adgaon, Nashik, Maharashtra 422003 Nashik MAHARASHTRA
9422769516
drravi.shinde42@gmail.com
Dr Mrunalini Kalikar
Government Medical College and Hospital
Department Of Pharmacology ,
Government Medical College and Hospital,
Medical Square Road, Nagpur-440003,
Maharashtra, India Nagpur MAHARASHTRA
9850045375
mrunalinikalikar@yahoo.com
Dr Pradeep DCosta
KEM Hospital Research Center
KEM Hospital Research Center, Sardar Moodliar Road, Rasta peth, Pune-411011, Maharashtra, India Pune MAHARASHTRA
09822632812
pradeepdcosta@yahoo.co.in
Dr Niteen Karnik
Lokmanya Tilak Muncipal Medical College and General Hospital
Professor and Head, Department of Medicine, LTM Medical College and LTMG Hospital, Sion (West), Mumbai-400022. Mumbai MAHARASHTRA
9821483404
drndkarnik@hotmail.com
Dr Girish Rajadhyaksha
N Medical College and B.Y.L Nair Ch. Hospital
Room no. 104, 1st Floor, Medicine Department,
College Building, T.N Medical College and B.Y.L Nair Ch. Hospital,
Mumbai Central, Mumbai-400008.
Mumbai MAHARASHTRA
9821695349
girishraj63@hotmail.com
Dr Aneesh Raj
NIMS, Thiruvananthapuram
NIMS Medicity, Aralummoodu, P.O.,Neyyattinkara, Thiruvananthpuram-695123, Kerala, India Thiruvananthapuram KERALA
GSMC 101-C, Department of Pharmacology and Therapeutics, 1st Floor, College Building, Seth GS medical college and KEM Hospital, Acharya Donde Road, Parel, Mumbai-400012. Mumbai MAHARASHTRA
9820165681
drsandhyakamat@gmail.com
Dr Akash Balki
Shree Hospital and critical care centre, Nagpur
Shree Hospital and critical care centre,
799, Omnagar, opp. Tajshree Building,
Sakkardara Sq. Nagpur-440009,
Maharashtra, India
Nagpur MAHARASHTRA
Ethics Committee of Bangalore Medical College and Research Institute
Approved
IEC NIMS
Approved
IEC, Dr Vasantrao Pawar Medical College, Nashik
Approved
Institutional Ethics Committee (IEC) - I Seth GS Medical College and KEM hospital, Mumbai
Approved
Institutional Ethics Committee - Care Hospital
Approved
Institutional Ethics Committee Human Research Lokmanya Tilak Muncipal Medical College and General Hospital
Approved
Institutional Ethics Committee Topiwala National College and BYL Nair CH. Hospital
Approved
Institutional Ethics Committee, GGMC, Mumbai
Approved
Institutional Ethics Committee, Govt Medical College, Nagpur
Approved
Institutional Ethics Committee, Neelima Hospitals
Approved
Institutional Ethics Committee, Neelima Hospitals
Approved
KEM Hospital Research Centre Ethics Committee
Approved
Shree Hospital Ethics Committee
Approved
Siddhi Hospital Institutional 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 200 mg / 400 mg
3600 mg (1800 mg orally twice daily) on 1st day followed by 800 mg orally twice daily, up to maximum of 14 days
Comparator Agent
NA
NA
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Adult patients aged 18 years and above with mild to moderate COVID-19.
2. Patients who receive a prescription of favipiravir according to the indication stated in the approved prescribing information in India
3. Pyrexia (defined as axillary temperature more than or equal to 99 F or oral temperature more than or equal to 100 F) AND at least one of the following: Cough, fatigue, dyspnoea, expectoration, myalgia, rhinorrhoea, sore throat, diarrhoea, new loss of taste or smell, myalgia, headache or fatigue on admission.
4. Respiratory rate less than or equal to 30/min.
5. SpO2 more than or equal to 90% on room air.
6. Agree to follow effective contraceptive methods during and for 7 days after the end of the treatment with favipiravir for male and female patients in the reproductive age group.
7. For female patients of child-bearing age: evidence of negative pre-treatment urine pregnancy test
8. Voluntarily participating in the study; fully understanding and being fully informed of the study and having signed written Informed Consent Form (ICF). Also if a pregnancy is reported, consent should be given for follow up of pregnancy until outcome.
ExclusionCriteria
Details
1. Refusal to participation expressed by patient or legally authorized representative.
2. Requiring NIV, Mechanical Ventilation or ECMO at baseline.
3. Severe hepatic or renal impairment
4. Pregnant or lactating women.
5. History of known hypersensitivity to Favipiravir.
6. Requires ICU care for management of ongoing clinical status (respiratory failure, septic shock, and/or multiple organ dysfunction or failure)
7. Patients who have participated in any clinical trial within 30 days prior to enrolment and would not be participating in clinical study during the period of study participation.
8. Any other COVID-19 antiviral treatment.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To evaluate the safety of favipiravir prescribed in treatment of patients with mild to moderate COVID-19 disease in India.
1. Number of AEs
2. Number of SAEs
3. Number of treatment related AEs and SAEs as assessed by the treating physician
4. Number of AEs leading to dose modification/ discontinuation of treatment
Upto 28 days
Secondary Outcome
Outcome
TimePoints
1. Time to clinical cure
Defined as resolution of baseline clinical signs and symptoms of COVID-19 infection based on clinical assessment by the investigator.
2. Rate of clinical cure.
3. Time to resolution of Pyrexia
4. Percentage of patients requiring AOT/NIV/MV/ECMO support.
5. Time to hospital discharge for hospitalized patients.
6. All-cause mortality rate.
1. Upto 14 days
2. At Day 7 and 14
3. Upto 14 days
4. At Day 7 and 14
5. Upto 14 days
6. At Day 7, 14 and 28
Target Sample Size
Total Sample Size="1200" Sample Size from India="1200" Final Enrollment numbers achieved (Total)= "1000" Final Enrollment numbers achieved (India)="1000"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a prospective, open label, multicenter, single arm, post marketing study for evaluation of safety and efficacy of
Favipiravir in Adult Indian Patients with Mild to Moderate COVID-19 disease. Primary objective of the study is to evaluate safety and secondary objective is to evaluate efficacy of Favipiravir in mild to moderate cases of COVID-19. 1200 adult patients will be enrolled in the study. The anticipated maximum total study duration for
each patient is approximately 30 days (maximum) which includes screening of up to 2 days, enrolment of 1 day, actual
treatment period as per treating physician’s prescription (up to 14 days
maximum), and an on-site/centre follow-up visit/telephonic follow-up after
completion of treatment which would be a routine follow up visit per normal
clinical practice.