| CTRI Number |
CTRI/2020/06/025799 [Registered on: 10/06/2020] Trial Registered Prospectively |
| Last Modified On: |
18/10/2021 |
| 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
|
|
|
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
|
|
|
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) |
Suspended |
|
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 |