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CTRI Number  CTRI/2020/04/024858 [Registered on: 25/04/2020] Trial Registered Prospectively
Last Modified On: 25/04/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   “To study the effectiveness of Ivermectin with standard of care treatment versus standard of care treatment for COVID 19 cases. A Pilot Study 
Scientific Title of Study   “To study the effectiveness of Ivermectin with standard of care treatment versus standard of care treatment for COVID 19 cases. A Pilot Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sandeep Budhiraja 
Designation  Group Medical Director Director 
Affiliation  Internal Medicine, Max Super Speciality Hospital (DDF), Saket 
Address  Max Super Speciality Hospital (DDF), East Block, Internal Medicine department, 2- Press Enclave Road, New Delhi

New Delhi
DELHI
110017
India 
Phone    
Fax    
Email  sbudhiraja@maxhealthcare.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ram Shankar Mishra 
Designation  Director- Internal Medicine 
Affiliation  Internal Medicine, Max Super Speciality Hospital (DDF), Saket 
Address  Max Super Speciality Hospital (DDF), East Block, Internal Medicine Department, 2- Press Enclave Road, New Delhi

New Delhi
DELHI
110017
India 
Phone  9810193145  
Fax    
Email  docmishra@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Rajesh Saxena 
Designation  General Manager 
Affiliation  Office of research, Max Super Speciality hospital, Saket (A unit of Devki Devi Foundation) 
Address  Max Super Speciality Hospital (DDF), East Block, Service Floor, 2- Press Enclave Road, New Delhi

New Delhi
DELHI
110017
India 
Phone  9818474003  
Fax    
Email  rajesh.saxena@maxhealthcare.com  
 
Source of Monetary or Material Support  
Max Super Speciality Hospital (DDF) Saket 
 
Primary Sponsor  
Name  Max Super Speciality Hospital A Unit of Devki Devi Foundation 
Address  2, Press Enclave Road, Saket, New Delhi-17 
Type of Sponsor  Private hospital/clinic 
 
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 Sandeep Budhiraja  Max Super Speciality hospital, Saket (A unit of Devki Devi Foundation)  Department of Internal Medicine, 2, Press Enclave Road, Saket, New Delhi-17
New Delhi
DELHI 
9810262954

sbudhiraja@maxhealthcare.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B338||Other specified viral diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ivermectin  Cases of COVID 19 shall be treated with Ivermectin 200 to 400mcg per kg body weight on day 1 and day 2 along with standard treatment of the hospital protocol 
Comparator Agent  Standard treatment as per hospital protocol for COVID 19  Cases of COVID 19 shall be treated with standard treatment as per hospital protocol for COVID 19 until the recovery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Subjects within age group between 18 to 75 years
2. With either sex, male or female
3. Confirmed case of COVID-19 at Max Hospitals. 
 
ExclusionCriteria 
Details  Patients who are critically sick  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
This study aims to confirm the antivirus effectiveness of Ivermectin on coronavirus i.e COVID 19
then to explore its potential use in the combating to the COVID 19 pandemics.  
Viral load will be monitored at 1, 3 & 5 days from beginning of trial drug (48 hours interval) Until the report comes negative. Drug will be delivered on daily basis upto eradication of virus or completion of
the trial 
 
Secondary Outcome  
Outcome  TimePoints 
Safety of the drug vs standard care of treatment will be checked   Treatment will be provided until the eradication of virus or completion of
the trial. 
 
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   N/A 
Date of First Enrollment (India)   25/04/2020 
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    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Coronavirus disease (COVID-19) is an infectious disease caused by a new virus. The disease causes respiratory illness (like the flu) with symptoms such as a cough, fever, and in more severe cases, difficulty breathing. At present, there are no specific treatments for COVID-19. WHO recommends four treatments for COVID 19 with drugs i.eRemdesivir, Lopinavir/ ritonavir, Lopinavir/ ritonavir with interferon beta -1a, and chloroquine or hydroxychloroquine. Currently, there are several ongoing clinical trials evaluating potential treatments. Recently, LeonCaly report here that 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 effect ∼5000-fold reduction in viral RNA at 48 h. Ivermectin therefore warrant further investigation for possible benefits in humans. The study rationale is to understand the effect of the drug on eradication of virus. This study aims to confirm the antivirus effectiveness of Ivermectin on coronavirus i.e COVID 19 then to explore its potential use in the combating to the COVID 19 pandemics.

Enrollment of subject into the trial shall only occur after providing written permission to voluntarily participate into the study by signing and dating the informed consent form before starting any trial related treatment. 50 cases of COVID-19 will be enrolled into the trial. The trial shall be divided into two groups. First group with 25 confirmed cases of COVID 19 shall be treated with Ivermectin 200 to 400mcg per kg body weight on day 1 and day 2 along with standard treatment of the hospital protocol. The second group with 25 confirmed cases of COVID 19 shall be treated with standard treatment as per hospital protocol for COVID 19. Subjects in both the arms shall be followed up for recovery of death with regular monitoring as per below schedule. 

 Test for virus at 1, 3 & 5 days from beginning of trial drug started for the patient in the hospital 
 Clinical profile of the patient every day of hospitalization 
 Investigation of pulmonary function and O2 saturation every day of hospitalization 
 The day a patient is put on ventilator and the day when removed 
 The day a patient develops acute respiratory distress syndrome and the day when relieved 

All the above data shall be collected on paper case record form for interim and final analysis from start of the trial i.e enrolment, treatment and follow-up. Viral test to monitor the eradication of Virus shall be done free of cost from third day of enrollment and providing the study drug on daily basis upto eradication of virus or completion of the trial.
 
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