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CTRI Number  CTRI/2020/05/025068 [Registered on: 07/05/2020] Trial Registered Prospectively
Last Modified On: 07/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Can a medicine help in curing viral infection 
Scientific Title of Study   A Phase IIB open label randomized controlled trial to evaluate the efficacy and safety of Ivermectin in reducing viral loads in patients with hematological disorders who are admitted with COVID 19 infection 
Trial Acronym  Not applicable 
Secondary IDs if Any  
Secondary ID  Identifier 
Not applicable  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Biju George 
Designation  Professor and Head 
Affiliation  Christian Medical College Vellore 
Address  Department of Haematology, First Floor, Room no-3, Christian Medical College

Vellore
TAMIL NADU
632004
India 
Phone  04162282352  
Fax  04162226449  
Email  biju@cmcvellore.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Biju George 
Designation  Professor and Head 
Affiliation  Christian Medical College Vellore 
Address  Department of Haematology, First Floor, Room no-3, Christian Medical College
Department of Haematology, First Floor, Room no-3, Christian Medical College

TAMIL NADU
632004
India 
Phone  04162282352  
Fax  04162226449  
Email  biju@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  Biju George 
Designation  Professor and Head 
Affiliation  Christian Medical College Vellore 
Address  Department of Haematology, First Floor, Room no-3, Christian Medical College
Department of Haematology, First Floor, Room no-3, Christian Medical College

TAMIL NADU
632004
India 
Phone  04162282352  
Fax  04162226449  
Email  biju@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
Christian Medical College Vellore, Ida Scudder Road, Vellore, 632004, Tamil Nadu 
 
Primary Sponsor  
Name  Christian Medical College Vellore 
Address  Christian Medical College, Vellore, 632004, Tamil Nadu, India 
Type of Sponsor  Other [Charitable trust hospital] 
 
Details of Secondary Sponsor  
Name  Address 
cience and Engineering Research Board SERB  5 & 5A, Lower Ground Floor Vasant Square Mall Sector-B, Pocket-5 Vasant Kunj New Delhi – 110 070 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Biju George  Christian Medical College Vellore  Department of Haematology, Christian Medical College, Vellore, 632004
Vellore
TAMIL NADU 
04162282352
04162226449
biju@cmcvellore.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee - Institution Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  B338||Other specified viral diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ivermectin  The doses are as follows (based on body weight) 15 - 24 kg: 3 mg PO once 25 - 35 kg: 6 mg PO once 36 - 50 kg: 9 mg PO once 51 - 65 kg: 12 mg PO once 66 - 79 kg: 15 mg PO once 80 kg and 15 kg: 200 ug/kg PO once 
Comparator Agent  patients will receive the standard protocol for management of COVID 19 infection.   patients will receive the standard protocol for management of COVID 19 infection.  
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Confirmed diagnosis of COVID19 infection based on +ve RTPCR

 
 
ExclusionCriteria 
Details  Patients with other viral infections 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study if Ivermectin can reduce the viral load in patients with hematological illnesses who are admitted with COVD19 infection  Day 7
 
 
Secondary Outcome  
Outcome  TimePoints 
To study the factors that affect viral load reduction
To study if the reduction in viral load correlates with improvement in inflammatory parameters
To study the incidence of serious adverse events and safety of this drug when used in hematological illnesses 
Day 7
Day 20 
 
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)   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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   We will plan to publish the results of this study in reputed National and International Journals. 
Brief Summary  

Corona virus disease 2019, a recently declared pandemic by the World Health Organization, is associated with a mortality ranging from 1-5% in immunocompetent individuals and will probably results in higher mortality in immunosuppressed patients. One of the important factors affecting outcomes including morality and ICU admission has been the viral load at the onset of disease and the rate of viral clearance. There are no standard drugs that are of proven benefit against the COVID 19 virus and majority of the treatment has been supportive. Recent data has suggested that ivermectin, an antiparasitic drug, is able to cause a 5000 fold reduction in viral RNA at 48 hours post exposure in cell lines. Ivermectin is a very safe drug to use in immunosuppressed patients for treatment of parasitic infections and has a good safety and tolerability profile.

In this study, we would like to randomize patients into 2 groups – group A will get the standard treatment protocol for COVID 19 infection as per institutional protocols and Group B will receive the standard treatment along with Ivermectin given on day 1 and Day 8. Baseline samples will be collected to look for presence of cytopenia, coagulopathy and also status of the immune system. The PCR samples will be stored for quantification of the viral load at a later point of time. PCR samples will be repeated on alternate days starting on Day 1 followed by 3, 5, 7, 10 and 14 and then at weekly intervals till discharge/death. All patients will be followed till recovery from illness or death. Blood parameters that are abnormal will be repeated twice a week till discharge.  We will study whether there is a rapid clearance of the virus with the use of ivermectin and whether that has led to better outcomes. 


Results and Conclusion:

We will be able to study if ivermectin reduces the viral load and whether this reduction will lead to stabilization of disease and clinical findings including the inflammatory parameters.


 
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