| CTRI Number |
CTRI/2022/07/043948 [Registered on: 12/07/2022] Trial Registered Prospectively |
| Last Modified On: |
16/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy and Safety Study of Antiviral Umifenovir 400mg Therapy in Mild COVID-19 Patients |
|
Scientific Title of Study
|
A Randomized, Double Blind, Multicenter, Parallel, Placebo Controlled Clinical Trial to Assess the Efficacy, Safety and Tolerability of Antiviral drug Umifenovir with Standard Care vs. Standard Care Therapy in Mild COVID-19 Patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 300-22, Version No. 02, Date-25-Apr-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kalyani Khandare MBBS |
| Designation |
Head-CT |
| Affiliation |
BioRadius Therapeutic Research Pvt. Ltd. |
| Address |
BioRadius Therapeutic Research Pvt. Ltd.
IndiaLand Global Industrial Park,
Plot No.8, S.No. 234, 235, 245,
Hinjawadi Phase I
Pune- 411057, Maharashtra, India.
Pune
MAHARASHTRA
411057
India |
| Phone |
020-67789100 |
| Fax |
- |
| Email |
drkalyanikhandare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalyani Khandare MBBS |
| Designation |
Head-CT |
| Affiliation |
BioRadius Therapeutic Research Pvt. Ltd. |
| Address |
BioRadius Therapeutic Research Pvt. Ltd.
IndiaLand Global Industrial Park,
Plot No.8, S.No. 234, 235, 245,
Hinjawadi Phase I
Pune- 411057, Maharashtra, India.
Pune
MAHARASHTRA
411057
India |
| Phone |
020-67789100 |
| Fax |
- |
| Email |
drkalyanikhandare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalyani Khandare MBBS |
| Designation |
Head-CT |
| Affiliation |
BioRadius Therapeutic Research Pvt. Ltd. |
| Address |
BioRadius Therapeutic Research Pvt. Ltd.
IndiaLand Global Industrial Park,
Plot No.8, S.No. 234, 235, 245,
Hinjawadi Phase I
Pune- 411057, Maharashtra, India.
Pune
MAHARASHTRA
411057
India |
| Phone |
020-67789100 |
| Fax |
- |
| Email |
drkalyanikhandare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medizest Pharmaceuticals Pvt Ltd India |
|
|
Primary Sponsor
|
| Name |
Medizest Pharmaceuticals Pvt Ltd India |
| Address |
Medizest Pharmaceuticals Pvt Ltd L-40 Verna Industrial Estate Verna GOA 403710 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Council of Scientific and Industrial Research CSIRCentral Drug Research Institute CDRI |
Council of Scientific and Industrial Research (CSIR)-Central
Drug Research Institute (CDRI)
Sector 10,
Jankipuram Extension,
Sitapur Road
Lucknow– 226031 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Surendra K MD Pulmonologist |
Chalasani Hospitals Pvt. Ltd. |
Chalasani Hospitals Pvt. Ltd.
Door no, 50-53-14, Gurudwara Rd, Balayya Sastri Layout, Seethammadara, Visakhapatnam, Andhra Pradesh 530013
Visakhapatnam
ANDHRA PRADESH |
020-67789100
suren44konathala@gmail.com |
| Dr Patel Zebeeuddin Imtiyazuddin |
Ishwar Institute of Health Care |
Ishwar Institute of Health Care, Ishwar Heights, 1st floor, Plot No. 7 ,Gut
No.6/1.Beside Punjabi Bhavan,Padegaon,Aurangabad-431002,
Maharashtra. India
Aurangabad
MAHARASHTRA |
020-67789100
-
ishwarhealthcare@gmail.com |
| Dr Virendra Atam MBBS MD |
King George Medical University, Lucknow |
King George Medical University, Lucknow, Shah Mina Rd, Chowk, Lucknow, Uttar Pradesh 226003
Lucknow
UTTAR PRADESH |
020-67789100
v_atam@yahoo.com |
| Dr Shivnitwar Sachin Kisan |
Lifepoint Multispecialty Hospital |
Lifepoint Multispecialty Hospital No. 145 Sr 1 Mumbai Pune Bypass Rd, Near Sayaji Hotel, Wakad, Pune, Maharashtra 411057
Pune
MAHARASHTRA |
020-67789100
-
sachinshivnitwar94@gmail.com |
| Dr Girish Gokuldas Bhatia |
Medipoint Hospital Pvt. Ltd |
Medipoint Hospital Pvt. Ltd, 241/ 1 New D .P road, Aundh, Pune 411007, Maharashtra,
India.
Pune
MAHARASHTRA |
020-67789100
-
drbhatia.pentagon@gmail.com |
| Dr Ambrish C |
Medstar Speciality Hospital |
Medstar Speciality Hospital, #641/17/1/3, Kodigehalli Main Road, Sahakarnagar, Bangalore- 560092, Karnataka, India.
Bangalore
KARNATAKA |
020-67789100
-
medstarclinicalresearch@gmail.com |
| Dr Ashish Omprakash Goyal |
Orchid Specialty Hospital |
Orchid Specialty Hospital, L- Square, Porwal Road, Sr. No. -282/3/3, Off
Dhanori, Jakat Naka, Lohgaon, Pune- 411047, Maharashtra, India.
Pune
MAHARASHTRA |
020-67789100
orchidhospital.research@gmail.com |
| Dr Waghela Vivek Ramesh |
ST. Georges Hospital |
ST. Georges Hospital, PD mello Road, Fort Road, Near CSMT
station, Mumbai 400001
Mumbai
MAHARASHTRA |
020-67789100
-
waghelavivek@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Ethics Committee of Ishwar Institute of HealthCare Ishwar Institute of Health Care |
Submittted/Under Review |
| ETHICS COMMITTEE OF TRAUMA CARE HOSPITAL TRAUMA CARE HOSPITAL |
Submittted/Under Review |
| IEC King George hospital KING GEORGE HOSPITAL |
Submittted/Under Review |
| Inst EC Eras Lucknow Medical College Hospital Eras Lucknow Medical College Hospital |
Submittted/Under Review |
| INSTITUTIONAL ETHICS COMMITTEE , GGMC, MUMBAI |
Submittted/Under Review |
| Institutional Ethics Committee Dr. Ram Manohar lohia Institute of Medical Sciences |
Submittted/Under Review |
| INSTITUTIONAL ETHICS COMMITTEE,QUEENS NRI HOSPITAL QUEENS NRI HOSPITAL |
Submittted/Under Review |
| Lifepoint Research- Ethics Committee |
Approved |
| Medstar Speciality Hospital Ethics Committee |
Approved |
| ORCHID SPECIALITY HOSPITAL ETHICS COMMITTEE |
Approved |
| Penta-Med Ethics Committee Medipoint Hospitals Pvt. Ltd |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: U071||COVID 19 virus identified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Placebo twice daily for 05 days |
| Intervention |
Umifenovir 400 mg tablets manufactured by Medizest Pharmaceuticals Pvt.
Ltd., Goa, India. |
Umifenovir 800 mg twice daily for 05 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Mild COVID 19 patients aged 18-60 years (inclusive), at the time of signing the
Informed Consent Form (ICF), with Nasopharyngeal swab positivity in RT-PCR
tests for SARS-Cov-2 antigens detected (within 72.0 hrs before visit 02) during
screening.
2. Case categories according to severity as per Ministry of health & Family welfare,
Govt. of India guidelines:
ï‚· Mild/Uncomplicated illness: Patients with uncomplicated upper respiratory
tract viral infection may have non-specific symptoms such as fever, cough,
expectoration, shortness of breath, myalgia, fatigue, sore throat, nasal
congestion, diarrhea, loss of taste with Nasopharyngeal swab positivity in
RT-PCR tests for SARS-Cov-2 antigens.
ï‚· Mild pneumonia with Nasopharyngeal swab positivity in RT-PCR tests for
SARS-Cov-2 antigens.
3. Additional Inclusion Criteria
a) For mild cases: The interval between symptoms onset (or day of contact with
a COVID-19 for asymptomatic patients detected during surveillance) and
randomization is no more than 7 days.
b) 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.
c) Should not participate in any other interventional drug clinical studies before
completion of the present study.
Patients with or without hospitalization or patients in institutional quarantine. If
the subject is hospitalized should fit in the working definitions of the mildly
symptomatic category of severity of COVID 19.
|
|
| ExclusionCriteria |
| Details |
1. Sepsis, Septic shock as defined in MOH&FW guidelines. The cases as need for
invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor
support. Inability to intake or tolerate oral medications.
2. Moderate and Severe COVID-19, as defined in (As per MOH, Govt. of India
guidelines)
3. Known allergy or hypersensitivity to Umifenovir.
4. Inability to intake or tolerate oral medications
5. Possibility of the subject being transferred to a non-study hospital within 72h.
6. Pregnant or lactating women.
7. Severe liver disease: underlying liver cirrhosis or alanine aminotransferase
(ALT)/aspartate aminotransferase (AST) elevated over 5 times the ULN;
8. Known severe renal impairment [creatinine clearance (CcCl) <30 mL/min] or
having received continuous renal replacement therapy, hemodialysis or peritoneal
dialysis.
9. Known disease or comorbid condition like asthma, diabetes with second-and
third-line medicines, insulin as defined in WHO guidance document.18
10. The disease or condition which may affect the study as decided by physician.
11. Where, in the opinion of the investigator, participation in this study will not be in
the best interest of the patient, or any other circumstances that prevent the patient
from participating in the study safely |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time from randomization to nasopharyngeal swab negativity by RT-PCR tests, for
SARS-Cov-2 will be assessed at intervals for 28 days or till RT-PCR negativity
whichever is earlier.
Prevention of Hospitalization among the two study treatments i.e. Test vs. Placebo. |
Intervals for 28 days or till RT-PCR negativity whichever is earlier. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time from randomization to clinical recovery or deterioration, assessed at 00, 03, 05, 07, 10, 14, 21, 28 days or till RT-PCR negative and at last follow-up visit, on eight category ordinal scale defined by WHO 19 |
Intervals for 28 days or till RT-PCR negativity whichever is earlier. |
|
|
Target Sample Size
|
Total Sample Size="735"
Sample Size from India="735"
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)
|
12/07/2022 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A Randomized, Double Blind, Multicenter, Parallel, Placebo Controlled Clinical Trial to Assess the Efficacy, Safety and Tolerability of Antiviral drug Umifenovir with Standard Care vs. Standard Care Therapy in Mild COVID-19 Patients. Primary outcome measures Time from randomization to nasopharyngeal swab negativity by RT-PCR tests, for SARS-Cov-2 will be assessed at intervals for 28 days or till RT-PCR negativity whichever is earlier. Prevention of Hospitalization among the two study treatments i.e. Test vs. Placebo. |