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CTRI Number  CTRI/2020/06/025799 [Registered on: 10/06/2020] Trial Registered Prospectively
Last Modified On: 06/08/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study of Favipiravir in patients with mild to moderate coronavirus disease (COVID-19)  
Scientific Title of Study   A Randomized, Open Label, Prospective, Comparative, Parallel Group, Multicentre Study To Evaluate Efficacy And Safety Of Favipiravir With Supportive Care Versus Supportive Care Alone In Subjects With Mild To Moderate Coronavirus Disease (COVID-19).  
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
CP/04/20, Version No. 1.0, dated 02/May/2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jaideep Gogtay 
Designation  Global Chief Medical officer 
Affiliation  Cipla Ltd 
Address  Cipla Ltd., 289 Bellasis Road, Mumbai Central East, Mumbai, Maharashtra 400008, India.

Mumbai
MAHARASHTRA
400008
India 
Phone  022-23025193  
Fax    
Email  jgogtay@cipla.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sandesh Sawant 
Designation  Director & Head Clinical trials 
Affiliation  Cipla Ltd 
Address  Cipla Ltd., 289 Bellasis Road, Mumbai Central East, Mumbai, Maharashtra 400008, India.

Mumbai
MAHARASHTRA
400008
India 
Phone  022-23025193  
Fax    
Email  sandesh.sawant3@cipla.com  
 
Details of Contact Person
Public Query
 
Name  Mr Abhijit Vaidya 
Designation  Senior Manager - Medical Affairs Department-Clinical research division  
Affiliation  Cipla Ltd 
Address  Cipla Ltd., 289 Bellasis Road, Mumbai Central East, Mumbai, Maharashtra 400008, India.

Mumbai
MAHARASHTRA
400008
India 
Phone  022-23025193  
Fax    
Email  abhijit.vaidya@cipla.com  
 
Source of Monetary or Material Support  
Cipla Ltd., Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai– 400013, India 
 
Primary Sponsor  
Name  Cipla Ltd 
Address  Cipla Ltd., Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai– 400013  
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 = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rohidas Borse   B.J.G.M College and Sassoon General Hospital  Sassoon Road, Station Road, Pune- 411001
Pune
MAHARASHTRA 
9923912525

Rohidas_borse@yahoo.co.in 
Dr Raja Dhar  Fortis Hospital  Department of Pulmonary Medicine, 730, E.M. Bypass Road, Anandpur, Kolkata 700107, West Bengal, India
Kolkata
WEST BENGAL 
9831855512

docaardee@yahoo.com 
Dr Vasant Nagvekar  Global Hospital  Infectious Diseases, 35, Dr. E, Dr Ernest Borges Rd, opp. Shirodkar High School, Parel, Mumbai, Maharashtra 400012
Mumbai
MAHARASHTRA 
9820055178

drnagvekar@gmail.com 
Dr Meenakshi Bhattacharya  Government Medical College & Hospital  Department of Medicine, Panchakki Road, Aurangabad 431001, Maharashtra, India
Aurangabad
MAHARASHTRA 
9922931527

meenakshi.medicine@gmail.com 
Dr Anand Kumar   GSVM Medical College  Murarli Lal Chest Hospital, Department of Tuberculosis and Respiratory Diseases, Near Rawatpur Crossing, Kanpur, Uttar Pradesh - 208002, India
Kanpur Nagar
UTTAR PRADESH 
7860965384

Dranandkumar.research@gmail.com 
Dr Ameet Dravid  Noble Hospital  Infectious Diseases Consultant, 153, Magarpatta Road, Hadapsar, Pune 411013, Maharashtra, India
Pune
MAHARASHTRA 
9975619766

ameet.dravid@gmail.com 
Dr Shreepad Bhat   Smt. Kashibai Navale Medical College and General Hospital  S.No. 49/1, Narhe, Off Pune- Mumbai Bypass, Pune- 411041
Pune
MAHARASHTRA 
9422364536

smb.med@gmail.com 
Dr Atul Patel   Sterling Cancer Hospital  Sterling hospital Lane, Sindhu bhavan Marg, Off. S.G. Highway, Bodakdev, Ahmedabad 380054, Gujarat, India.
Ahmadabad
GUJARAT 
079-40011622

atulpatel65@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
Ethics Committee GSVM Medical College   Approved 
Fortis Hospital Ethics Committee  Approved 
Global Hospital Institutional Ethics Committee  Submittted/Under Review 
Government Medical College Aurangabad Ethics committee  Approved 
IEC of B.J.G.M. C and Sassoon General Hospital  Submittted/Under Review 
Institutional Ethics Committee (IEC)  Approved 
Noble Hospital Institutional Ethics Committee  Approved 
Sterling Hospital Ethic committee  Submittted/Under Review 
 
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 oral tablets  1800 mg twice daily on Day 1 and 800 mg twice daily from Day 2 upto maximum 14 days along with supportive care  
Comparator Agent  Supportive care alone  Supportive care alone 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. A voluntarily given written signed dated informed consent from subjects and/or legally acceptable representative.
2. Subjects of either gender and age between 18 and 75 years.
3. Confirmed diagnosis of mild to moderate COVID-19. (positivity in RTPCR
2019-nCoV test on respiratory tract specimens).
4. In case of moderate COVID-19, subjects with CT or Chest X-ray
documented pneumonia.
5. Subjects with pyrexia (axillary ≥37℃ or oral ≥37.5℃, or rectal≥38℃)
or either respiratory rate >24/min and <30/min or cough.
6. Subjects within 7 days from symptom onset or within 48 hours of
laboratory diagnosis of SARS-CoV2.
 
 
ExclusionCriteria 
Details  1. Subjects with known allergy or hypersensitivity to Favipiravir or any of its components or to supportive care.
2. Subjects with Chronic liver disease (Child Pugh class B or C) and chronic renal disease (GFR<30ml/min).
3. Subjects with oxygen saturation (SPO2) ≤90% or arterial oxygen
partial pressure (PaO2)/ fraction of inspired O2 (FiO2) ≤300 mmHg.
4. Refractory nausea, vomiting, or chronic gastrointestinal disorders,
inability to swallow the study drug or having undergone extensive
bowel resection which may affect adequate absorption of Favipiravir.
5. Subjects with gout or hyperuricemia.
6. Pregnant or breast-feeding subjects.
7. Subject is using adrenocorticosteroids (except topical or inhaled
preparations) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers).
8. Subject has a serious chronic disease (e.g., human immunodeficiency virus (HIV), cancer requiring chemotherapy within the preceding 6 months, unstable cardiac, pulmonary, neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days.
9. Subject has a history of alcohol or drug abuse in the previous 6 months.
10. Subject has a psychiatric disease that is not well controlled where
controlled is defined as: stable on a regimen for more than one year.
11. Subject already treated with another COVID 19 therapy but has
relapsed with a positive diagnosis.
12. Anticipated transfer to another hospital which is not a study site
within 72 hours.
13. Participated in any other clinical trial or taken investigational drug
within 1 month.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Time from randomization to negativity in RT-PCR nucleic acid test. [defined as the presence of two consecutive negative results with RT-PCR detection over an interval of 24 hour]  Up to 28 days 
 
Secondary Outcome  
Outcome  TimePoints 
Time from randomization to clinical recovery(clinical recovery:normalization of pyrexia,respiratory rate and SPO2 and relief of cough that is maintained for at least 72 hours).Incidence of deterioration/aggravation of pneumonia.Time from randomization to resolution of pyrexia.Time from randomization to relief of cough.Time from randomization to relief of dyspnoea.Time to discharge from hospital.ICU admission rate. Adverse events(Serious/Non-serious,Expected/Unexpected,Related/Not Related)  Up to 28 days. Till discharge/death whichever is earlier (up to Day 28) 
 
Target Sample Size   Total Sample Size="156"
Sample Size from India="156" 
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)   17/06/2020 
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)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The study is a  randomized, open label, prospective, comparative, parallel group, multicentre study to evaluate efficacy and safety of Favipiravir with

supportive care versus supportive care alone in subjects with mild to moderate coronavirus disease (COVID-19)

 

The objective of study is to evaluate efficacy and safety of Favipiravir with supportive care versus supportive care alone in subjects with mild to moderate coronavirus disease (COVID-19).

 

CRO for this trial will be CBCC Global Research 
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