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CTRI Number  CTRI/2020/09/027535 [Registered on: 01/09/2020] Trial Registered Prospectively
Last Modified On: 26/11/2020
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 therapy in non-severe COVID- 19 patients. 
Scientific Title of Study   Phase 3, Randomized, Double-blind, Placebo control trial of Efficacy, Safety and Tolerability of Antiviral drug Umifenovir vs Standard care of therapy in non-severe COVID-19 patients. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CDRI-CLINICAL2/2020 version 2 dated 4th June 2020  Protocol Number 
U1111-1251-8421  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vivek Bhosale MD 
Designation  Senior Scientist 
Affiliation  CSIR-Central Drug Research Institute 
Address  CSIR-Central Drug Research Institute, Department of Toxicology and Experimental Medicine, Lab No. PCN 05, Sector 10, Jankipuram Extension, Sitapur Road, Lucknow, U.P., India.

Lucknow
UTTAR PRADESH
226031
India 
Phone  9450902041  
Fax    
Email  drvivekbhosale@cdri.res.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Vivek Bhosale MD 
Designation  Senior Scientist 
Affiliation  CSIR-Central Drug Research Institute 
Address  CSIR-Central Drug Research Institute, Department of Toxicology and Experimental Medicine, Lab no. PCN05, Sector 10, Jankipuram Extension, Sitapur Road, Lucknow, U.P., India.

Lucknow
UTTAR PRADESH
226031
India 
Phone  9450902041  
Fax    
Email  drvivekbhosale@cdri.res.in  
 
Details of Contact Person
Public Query  
Name  Dr Vivek Bhosale MD 
Designation  Senior Scientist 
Affiliation  CSIR-Central Drug Research Institute 
Address  CSIR-Central Drug Research Institute, Department of Toxicology and Experimental Medicine, Lab no. PCN05, Sector 10, Jankipuram Extension, Sitapur Road, Lucknow, U.P., India.

Lucknow
UTTAR PRADESH
226031
India 
Phone  9450902041  
Fax    
Email  drvivekbhosale@cdri.res.in  
 
Source of Monetary or Material Support  
CSIR-Central Drug Research Institute, Sector 10, Jankipuram Extension, Sitapur Road, Lucknow 226031 
Medizest Pharmaceuticals Pvt.Ltd Plot No- L 40 Verna Industrial Estate ,Verna Goa 
 
Primary Sponsor  
Name  Director CSIR Central Drug Research Institute 
Address  Sector 10, Jankipuram Extension, Sitapur Road, Lucknow, U.P. India 226031 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr M MA Faridi  Era s Lucknow Medical College and Hospital  Department of Medicine, Hardoi Rd, Sarfarazganj, Lucknow, Uttar Pradesh 226003
Lucknow
UTTAR PRADESH 		 91-522-6600777

drmmafaridi@gmail.com 
Dr Virendra Atam  King George Medical University  Department of Medicine, Shah Mina Rd, Chowk, Lucknow, Uttar Pradesh 226003
Lucknow
UTTAR PRADESH 		 91-522-2421421

vatam02@gmail.com 
Dr Vikram Singh   RML Institute of Medical Sciences  Department of Medicine, Vibhuti Khand, Gomti Nagar, Lucknow, Uttar Pradesh, India 226010
Lucknow
UTTAR PRADESH 		 91-522-6600777

vikramrpsingh@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee Dr. Ram Manohar Lohia Institute of Medical Sciences  Approved 
Institutional Ethics Committee Eras Lucknow Medical College & Hospital  Approved 
Institutional Ethics Committee King Georges Medical College  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 
Comparator Agent  Standard of care  Standard of care for COVID-19 
Intervention  Umifenovir  Oral Umifenovir 800mg twice daily for 14 days + standard care of therapy. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Asymptomatic persons WITH Nasopharyngeal swab positivity in RT-PCR tests for SARS-Cov-2 antigens.
2. Case categories as uncomplicated illness, Mild pneumonia, Moderate pneumonia according to severity WITH Nasopharyngeal swab positivity in RT-PCR tests for SARS-Cov-2 antigens as per Ministry of health & Family welfare, Govt of India guidelines. 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.
Mild pneumonia WITH Nasopharyngeal swab positivity in RT-PCR tests for SARS-Cov-2 antigens. Moderate pneumonia is defined as Adults with presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 <94% (range 90-94%) on room air, Respiratory Rate more or equal to 24 per minute.
3. 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.
4. Not participating in any other interventional drug clinical studies before completion of the present study.

 
 
ExclusionCriteria 
Details  • Severe COVID-19, as defined in Ministry of Health, Govt of India guidelines. Adolescent or adult: fever or suspected respiratory infection, plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2 <90% on room air, Cases of Acute respiratory distress syndrome (ARDS).
• 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.
o Known allergy or hypersensitivity to Umifenovir
o Possibility of the subject being transferred to a non-study hospital within 72h
o Pregnant or lactating women
o Severe liver disease: underlying liver cirrhosis or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 5 times the ULN;
o Known severe renal impairment [creatinine clearance (CcCl) <30 mL/min] or having received continuous renal replacement therapy, hemodialysis or peritoneal dialysis.
O Known disease or comorbid condition like asthma, diabetes with second-and third-line medicines, insulin as defined in WHO guidance document.18
O The disease or condition which may affect the study as decided by physician.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Time from randomization to nasopharyngeal swab negativity by RT-PCR tests.
For moderate patients, the end point will be time to improvement by one category from randomisation on the eight-category ordinal scale defined by WHO & average change in the ordinal scale from baseline. 		 For examination and other tests, the time points are baseline, 7, 14, 21, 28 days. The nasopharyngeal swab testing will be done at baseline, fifth day and subsequently every 48 hours upto 21 days and then on 28 day or till it becomes negative whichever is earlier. 
 
Secondary Outcome  
Outcome  TimePoints 
Time from randomization to clinical recovery or deterioration, on eight-category ordinal scale defined by WHO.

Proportion of patients to clinical recovery or deterioration, on eight-category ordinal scale defined by WHO

Proportion of patients hospitalized with Severe Covid-19 pnemonia (with respiratory rate ≥30/minute and/or SpO2 90% in room air) or ARDS or Septic shockas per Ministry of health, Govt of India guidelines.

Adverse events in two groups.

 		 At 0, 7, 14, 21 and 28 days 
 
Target Sample Size   Total Sample Size="132"
Sample Size from India="132" 
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)   08/09/2020 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The emergence of SARS-CoV-2 infection, also known as a 2019- nCoV disease (COVID-19), is continuously increasing. The SARS-CoV-2 infection causes a spectrum of respiratory illness, from asymptomatic to fatal pneumonia. The WHO has declared it as pandemic. There is no approved therapy for corona virus disease. There is unmet medical need for newer therapies to reduce morbidity and mortality.. Umifenovir (also known as Arbidol) is another antiviral agent that has been approved in China and Russia for treating influenza, SARS, and Lassa viruses. A limited number of case reports showed that patients with COVID-19 successfully recovered after receiving lopinavir/ritonavir and Umifenovir treatment, however, it is difficult to prove whether they were cured by the antiviral agent or just a natural course of COVID-19. Hence further investigation is needed to prove efficacy and safety. 

Arms and Interventions: Arm 1: Umifenovir 800 mg twice daily for 14 days + standard care of therapy. Arm 2: Standard care of therapy. The standard care of therapy is as per the hospital protocol and as per Ministry of Health, Govt. of India COVID-19 treatment guidelines adopted by trial centre.


 
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