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CTRI Number  CTRI/2020/05/025224 [Registered on: 18/05/2020] Trial Registered Prospectively
Last Modified On: 16/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to efficacy of Ivermectin in patients of COVID-19 
Scientific Title of Study   Interventional study to assess the efficacy of Ivermectin with standard of care treatment versus standard of care in patients of COVID-19 at R D Gardi Medical College, Ujjain, India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sunil Rathi  
Designation  Professor 
Affiliation  R D Gardi Medical College 
Address  3rd Floor, Department of Pediatrics
R D Gardi Medical College Agar Road, Surasa
Ujjain
MADHYA PRADESH
456006
India 
Phone  9425093116  
Fax    
Email  sunil.k.rathi.59@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashish Pathak  
Designation  Professor 
Affiliation  R D Gardi Medical College 
Address  3rd Floor, Department of Pediatrics C R Gardi Hospital
R D Gardi Medical College Agar Road, Surasa
Ujjain
MADHYA PRADESH
456006
India 
Phone  9302239899  
Fax    
Email  drashish.jpathak@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ashish Pathak  
Designation  Professor 
Affiliation  R D Gardi Medical College 
Address  3rd Floor, Department of Pediatrics C R Gardi Hospital
R D Gardi Medical College Agar Road, Surasa
Ujjain
MADHYA PRADESH
456006
India 
Phone  9302239899  
Fax    
Email  drashish.jpathak@gmail.com  
 
Source of Monetary or Material Support  
R D Gardi Medical College Agar Road, Surasa, Ujjain Madhya Pradesh 456006 India 
 
Primary Sponsor  
Name  R D Gardi Medical College 
Address  Agar Road, Surasa, Ujjain Madhya Pradesh 456006 India 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashish Pathak  R D Gardi Medical College, Ujjain   3rd Floor, Department of Pediatrics C R Gardi Hospital R D Gardi medical College
Ujjain
MADHYA PRADESH 
9302239899

drashish.jpathak@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, R D Gardi Medical College, Ujjain   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ivermectin  Ivermectin 12mg OD at night Route of administration- Oral Duration of therapy - 2 days with standard of care as per hospital guidelines  
Comparator Agent  Standard of care   Standard of care as per hospital guidelines. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Adults (age ≥18 years to ≤75 years) 2. Laboratory-confirmed SARS-CoV-2 infection and, in the view of the responsible doctor, no contra-indication to any of the study treatments 3. Hospitalized at R D Gardi Medical College, Ujjain Madhya Pradesh  
 
ExclusionCriteria 
Details  1. Anticipated transfer to another hospital, within 72 hours, which is not a study site 2. Known allergy to study medication or its components (non-medicinal ingredients) 3. Known HIV infection 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Effect of Ivermectin on eradication of virus.
Test for virus at 1, 3 and 5 days from beginning of trial drug started for the patient in the hospital
 
3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Overall safety of the study drug
2. Duration of hospitalization
3. Improvement in the abnormal laboratory values 
3 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 2 
Date of First Enrollment (India)   24/05/2020 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Results will be published in relevant open access peer-reviewed scientific journals. 
Brief Summary  

The aim of this study is to validate the antivirus effectiveness of Ivermectin on coronavirus i.e COVID 19 and study its effectiveness in combating COVID 19 pandemics.

 

At present, there are no specific treatments for COVID-19. Ivermectin, an FDA-approved anti-parasitic previously shown to have broad-spectrum anti-viral activity in vitro, is an inhibitor of the causative virus (SARS-CoV-2), with a single addition to Vero-hSLAM cells 2 hours post infection with SARSCoV-2 able to affect about 5000-fold reduction in viral RNA at 48 h. Ivermectin is a CDSCO approved drug. However, it requires further investigation for possible benefits COVID-19 patients and further eradication of COVID-19 virus. 
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