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CTRI Number  CTRI/2020/08/027282 [Registered on: 20/08/2020] Trial Registered Prospectively
Last Modified On: 19/08/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Prophylactic Ivermectin in COVID 19 Contacts  
Scientific Title of Study   Effectiveness of Ivermectin in preventing development of symptomatic Covid-19 among primary contacts of newly diagnosed Covid-19 positive patients at a tertiary care hospital in North India - an interventional 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 Rambha Pathak  
Designation  Dean Prof. and head  
Affiliation  Govt Institute of Medical Sciences  
Address  Room no. 135 Deans office Government Institute of Medical Sciences Greater Noida UP

Gautam Buddha Nagar
UTTAR PRADESH
201312
India 
Phone  8826843180  
Fax    
Email  rambha_p@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Saurabh Srivastava 
Designation  Prof. & Head, Dept. of Medicine 
Affiliation  Govt Institute of Medical Sciences  
Address  Room No.101 Department of Medicine Government Institute of Medical Sciences Greater Noida UP

Gautam Buddha Nagar
UTTAR PRADESH
201312
India 
Phone    
Fax    
Email  saurabhsrivas@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Hariom Kumar Solanki 
Designation  Assistant Professor 
Affiliation  Govt Institute of Medical Sciences  
Address  Room no. 401 Department of Community Medicine Government Institute of Medical Sciences Greater Noida UP

Gautam Buddha Nagar
UTTAR PRADESH
201312
India 
Phone    
Fax    
Email  hariom.mamc@gmail.com  
 
Source of Monetary or Material Support  
Director Government Institute of Medical Sciences Greater Noida Gautam Budh Nagar Uttar Pradesh 201310 
 
Primary Sponsor  
Name  Department of Community Medicine  
Address  Govt. Institute of Medical Sciences Greater Noida Gautam Budh Nagar Uttar Pradesh 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr Rakesh Gupta  Govt. Institute of Medical Sciences Greater Noida UP 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rambha Pathak  Government Institute of Medical Sciences  Room no. 135 Dept. of Community Medicine Govt Institute of Medical Sciences Greater Noida UP
Gautam Buddha Nagar
UTTAR PRADESH 
08826843180

rambha_p@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GIMS INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy contact of COVID 19 Patients 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ivermectin 12mg or Ivermectin 36mg single dose orally once only  The study will have two intervention arms. In the intervention Arm 1: 12mg oral Ivermectin will be given to the close family contacts fulfilling the inclusion- exclusion criteria for this study; of the newly diagnosed Covid-19 patient within 24 hours of diagnosis. The drug will be given orally and once only (under supervision). In the intervention Arm 2: 36 mg oral Ivermectin will be given to the close family contacts fulfilling the inclusion- exclusion criteria for this study; of the newly diagnosed Covid-19 patient within 24 hours of diagnosis. The drug will be given orally and once only (under supervision).  
Comparator Agent  Two Multivitamin tablets   In the control group - each participant will be given 2 (two) multivitamin tablets (available in the supply at the study institute). These tablets will be given orally, under-supervision and only once.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All the family members of a newly diagnosed Covid-19 patient who are - living with the patient in the last 2 weeks, aged between 18 years and 60 years of age, asymptomatic on the day of diagnosis of the index case.  
 
ExclusionCriteria 
Details  The following will be excluded from the study:
1. Pregnant or lactating women
2. Those with any degree of ARI symptoms or fever.
3. Person with known history of severe hypersensitivity reaction to previous exposure to Ivermectin.
4. People with pre-existng severe medical conditions according to the judgement of
the investigators 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Symptomatic Covid-19 among the study participants  Between 7 and 10 days of Ivermectin intake 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse effects of Ivermectin experienced by the study participants  On the day of Ivermectin intake and between 7 and 10 days of Ivermectin intake 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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)   31/08/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   1. Şimşek Yavuz S, Ünal S. Antiviral treatment of COVID-19. Turk J Med Sci. 2020;50(SI-1):611-619. Published 2020 Apr 21. doi:10.3906/sag-2004-145. 2. Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDAapproved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020. https://doi.org/ 10.1016/j.antiviral.2020.104787 3. Patrì A, Fabbrocini G. Hydroxychloroquine and ivermectin: A synergistic combination for COVID-19 chemoprophylaxis and treatment?. J Am Acad Dermatol. 2020;82(6):e221. doi:10.1016/j.jaad.2020.04.017.  
Brief Summary   Effective medical prophylaxis can help in curbing the transmission of COVID 19. Ivermectin has been found to be having antiviral properties against SARS-COV-2 virus  and trials have been started in various parts of the world to study the effectiveness of Ivermectin as a post exposure prophylaxis of COVID 19.  Keeping this in view an attempt is being made in the study to determine the effectiveness of single-dose ivermectin 12mg or 36mg in reducing the probability of contracting the infection from positive household contacts in India.   
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