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CTRI Number  CTRI/2020/05/025333 [Registered on: 24/05/2020] Trial Registered Prospectively
Last Modified On: 22/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to assess efficacy of Ivermectin as prophylaxis of COVID -19 
Scientific Title of Study   Study to assess the efficacy of Ivermectin as prophylaxis of COVID 19 among health care workers and COVID 19 contacts in 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 C R Gardi Hospital 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


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 
 
Primary Sponsor  
Name  R D Gardi Medical College 
Address  R D Gardi Medical College Agar Road, Surasa Ujjain Madhya Pradesh 
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 Agar Road, Surasa
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 
Healthy Human Volunteers  Healthy health care workers or Healthy contact of COVID 19 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control- No intervention  Control- No intervention 
Intervention  Ivermectin   Ivermectin 12 mg OD, oral, for 2 days in adults and 6 mg OD oral, for 2 days in children.  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Following are eligible to participate after giving written consent/assent -
1. Healthy health care workers
2. Contact of COVID 19 
 
ExclusionCriteria 
Details  1. Un healthy 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 as prophylaxis of virus

Outcome indicators are :
1. Resolution of sign and symptoms of COVID 19
2. Negative RTPCR done 48 hours after Ivermectin dose
OR
Change /reduction in CT value as reported in RTPCR for SARS-COV-2 virus assay.
 		 Change /reduction in CT value as reported in RTPCR after 48 hours of administration drug.  
 
Secondary Outcome  
Outcome  TimePoints 
Overall safety of the study drug

The drug is safe in general. However, safety would be monitored by charting adverse events after administration of the drug for 7 days. This will be part of case report form.
Secondary outcome indicators: No adverse event after administration of the drug. Adverse events will be systematically recorded and notified to institutional ethics committee
Lab values : CT value of RTPCR as reported in primary outcome.
 		 7 Days 
 
Target Sample Size   Total Sample Size="2000"
Sample Size from India="2000" 
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)   27/05/2020 
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. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This aims of this study is to validate the antivirus effectiveness of Ivermectin as prophylaxis 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.  
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