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CTRI Number  CTRI/2020/08/027225 [Registered on: 18/08/2020] Trial Registered Prospectively
Last Modified On: 18/08/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Ivermectin as a possible treatment for COVID-19 
Scientific Title of Study   Ivermectin as a potential treatment for COVID 19: A double blind randomized placebo-controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ravi Kirti 
Designation  Additional Professor  
Affiliation  All India Institute of Medical Sciences 
Address  Department of General Medicine, 1st Floor, OPD Building, AIIMS, Phulwari Sharif, Patna

Patna
BIHAR
801507
India 
Phone  9572424447  
Fax    
Email  drravikirti@aiimspatna.org  
 
Details of Contact Person
Scientific Query
 
Name  Ravi Kirti 
Designation  Additional Professor  
Affiliation  All India Institute of Medical Sciences 
Address  Department of General Medicine, 1st Floor,OPD Building AIIMS, Phulwari Sharif Patna

Patna
BIHAR
801507
India 
Phone  9572424447  
Fax    
Email  drravikirti@aiimspatna.org  
 
Details of Contact Person
Public Query
 
Name  Ravi Kirti 
Designation  Additional Professor  
Affiliation  All India Institute of Medical Sciences 
Address  Department of General Medicine 1st Floor, OPD Building AIIMS, Phulwari Sharif Patna

Patna
BIHAR
801507
India 
Phone  9572424447  
Fax    
Email  drravikirti@aiimspatna.org  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Phulwari Sharif, Patna 801507 
 
Primary Sponsor  
Name  AIIMS Patna 
Address  Phulwari Sharif Patna 801503 
Type of Sponsor  Research institution and hospital 
 
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 
Ravikirti  AII India Institute of Medical Sciences, Patna  COVID Wards, IPD Building, AIIMS Phulwari Sharif Patna 801507
Patna
BIHAR 
9572424447

drravikirti@aiimspatna.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS, Patna  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  12 mg orally to be administered once daily on days 1 and 2 
Comparator Agent  Placebo tablets  A placebo tablet similar to Ivermectin 12 mg (provided by the manufacturer) to be given once daily on days 1 and 2. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients admitted with COVID-19 with mild to moderate severity 
 
ExclusionCriteria 
Details  History of allergy to Ivermectin
Unwillingness to participate in the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Negative RT-PCR  Day 6 
 
Secondary Outcome  
Outcome  TimePoints 
In-hospital mortality  NA 
ICU Admission  NA 
Mechanical Ventilation  NA 
Discharge by day 10  Day 10 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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   N/A 
Date of First Enrollment (India)   28/08/2020 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Brief Summary   Ivermectin is a widely used and safe anti-parasitic drug. It has been reported to have an in-vitro activity against SARS-CoV-2. However, no randomized controlled trial has been done yet to study the efficacy of this drug in COVID-19.

The proposed study is a single center study to assess the efficacy of the drug in COVID-19 cases with mild to moderate severity as defined by the Ministry of Health and Family Welfare, Government of India.


 
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