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CTRI Number  CTRI/2020/06/026232 [Registered on: 29/06/2020] Trial Registered Prospectively
Last Modified On: 29/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Trial 
Public Title of Study   Ivermectin in the prevention of covid-19  
Scientific Title of Study   A Clinical Trial to Study the Efficacy of “Ivermectin” in the prevention of Covid-19. .A Single Arm Study. “ 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  BKumar 
Designation  M.D,,DVFM 
Affiliation  DVFM 
Address  Department of Medicine, Sivajipalem Main road,

Visakhapatnam
ANDHRA PRADESH
530017
India 
Phone  9505637454  
Fax    
Email  bkumar09460946@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  BKumar 
Designation  M.D,,DVFM 
Affiliation  DVFM 
Address  Department of Medicine, Sivajipalem Main road,

Visakhapatnam
ANDHRA PRADESH
530017
India 
Phone  9505637454  
Fax    
Email  bkumar09460946@gmail.com  
 
Details of Contact Person
Public Query
 
Name  BKumar 
Designation  M.D,,DVFM 
Affiliation  DVFM 
Address  Department of Medicine, Sivajipalem Main road,

Visakhapatnam
ANDHRA PRADESH
530017
India 
Phone  9505637454  
Fax    
Email  bkumar09460946@gmail.com  
 
Source of Monetary or Material Support  
DVFM, Department Of Medicine, Block A , Sivajipalem main raoad, Sivajipalem Visakhapatnam-530017 Andhra pradesh  
 
Primary Sponsor  
Name  DVFM 
Address  Department of Medicine, Sivajipalem Main road ,Visakhpatnam-17 ANDHRA PRADESH 530017 India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 
BKumar  DVPM  Department of Medicine, Sivajipalem Main road ,
Visakhapatnam
ANDHRA PRADESH 
9505637454

bkumar09460946@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GMA INDEPENDENT ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human Volunteers who have high chances of exposure to COVID 19 patients  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ivermectin   Single oral dose of 200 mcg of ivermectin per kg of body weight. 
Comparator Agent  Not applicable   Not applicable  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Subjects who are not suffering from active illness due to infection at the time of inclusion .  
 
ExclusionCriteria 
Details  1.Pregnant and lactating women.
2.Subjects suffering from active illness due to infection at the time of inclusion.
3.Subjects suffering from uncontrolled DM, HTN etc
4.Subjects who are known cases of immune-compromised or autoimmune condition such as HIV. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Episodes and severity of symptoms of respiratory tract infection (cold, sore throat, dry cough, breathlessness) in subjects who may get direct or indirect exposure to COVID 19 patients.   From Baseline till the end of 15 days.  
 
Secondary Outcome  
Outcome  TimePoints 
Requirement of treatment for symptoms developed, if any, during study period.
Incidence of COVID 19 infection in study population.
Analysis of adverse events, if any  
From Baseline till the end of 15 days.
From Baseline till the end of 15 days.
From Baseline till the end of 15 days.
 
 
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 3 
Date of First Enrollment (India)   10/07/2020 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Brief Summary   COVID-19 ,a viral disease with common symptoms dry cough, fever, breath problems , fatigue , loss of smell and others.

Prevent is better option than treatment .

There are many possible methods to prevent Covid-19 , Mask usage , Maintain social distance , frequent hand wash and others . But in world wide the positive of COVID-19 increasing very fast.

IVERMECTIN is approved by DCGI ,Government of India for anti-parasitic but this medicine have anti viral properties.

This IVERMECITIN may prevent Covid-19 Infection .At  starting point of viral infection the Viral load is very much less . So this medicine may prevent Covid-19 infection .It is very safe drug .
 
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