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CTRI Number  CTRI/2020/05/025242 [Registered on: 19/05/2020] Trial Registered Prospectively
Last Modified On: 18/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Hydroxychloroquine of pharmacokinetics in healthcare workers 
Scientific Title of Study   Population pharmacokinetics of hydroxychloroquine sulphate in healthcare workers given for prophylaxis against Corona Virus Disease 2019 (COVID 19) pandemic in India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
83341  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nithya Gogtay 
Designation  Professor Additional 
Affiliation  Department of Clinical Pharmacology 
Address  Dept of Clinical Pharmacology 1st floor MS building Seth GSMC and KEM Hospital Acharya Donde marg Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  njgogtay@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nithya Gogtay 
Designation  Professor Additional 
Affiliation  Department of Clinical Pharmacology Seth GSMC and KEM Hospital 
Address  Dept of Clinical Pharmacology 1st floor MS building Seth GSMC and KEM Hospital Acharya Donde marg Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  njgogtay@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nithya Gogtay 
Designation  Professor Additional 
Affiliation  Department of Clinical Pharmacology Seth GSMC and KEM Hospital 
Address  Dept of Clinical Pharmacology 1st floor MS building Seth GSMC and KEM Hospital Acharya Donde marg Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  njgogtay@hotmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  V. Ramalingaswami Bhawan P O Box No 4911 Ansari Nagar New Delhi 110029 India 
Type of Sponsor  Government funding agency 
 
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 Nihtya Gogtay  Dept of Clinical Pharmacology  1st floor Seth GSMC and KEM Hospital Parel Mumbai
Mumbai
MAHARASHTRA 
02224133767

njgogtay@hotmail.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 
Healthy Human Volunteers  Healthcare workers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hydroxychloroquine sulphate  Oral tablet 400 mg twice a day on Day 1, followed by 400 mg once weekly for next 7 weeks to be taken with meals 
Comparator Agent  Not applicable  Single arm study 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Asymptomatic Health Care workers (HCWs) of any gender and conditions as follows:
age 18 -65 years (HCW who are actively on duty and not any who have retired) on prophylaxis with HCQ against COVID-19 infection – Group 1 without comorbiditie
age 18 -65 years (HCW who are actively on duty and not any who have retired) who are to be initiated on prophylaxis – Group 2 without comorbidities
age 18 -65 years (HCW who are actively on duty and not any who have retired) on prophylaxis with HCQ against COVID-19 infection with comorbidities (HT, Diabetes) – Group3
age 18 -65 years (HCW who are actively on duty and not any who have retired) who are to be initiated on prophylaxis – Group 2 with comorbidities (HT, Diabetes)
 
 
ExclusionCriteria 
Details  Health care workers who show symptoms suggestive of COVID-19 or are positive for COVID-19
Women of child bearing potential who are not willing for adequate contraception during the time of blood collection / who were not practicing adequate contraception in the last 28 days
Women who are pregnant or breast feeding
Participants who are not determined to be fit by the investigator
Participants who are prescribed HCQ for any other indication / history of taking HCQ in the last one year
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The modelling will help assess which of the variables including the presence of comorbidities (if any) would have the greatest impact on the drug concentrations in an Indian population. It would also help us understand if COVID-19 infection alters the pharmacokinetics of HCQ.   2-8 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
It would also help us understand the concentrations of HCQ in lung fluid using PBPK modelling  2-8 weeks 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   25/05/2020 
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   After data analysis , study will publish. 
Brief Summary  

Corona Virus Disease 2019 (COVID-19) had its origin in Wuhan, China in December 2019 and was subsequently found to have been caused by a novel corona virus named severe acute respiratory syndrome corona virus 2 (SARS-CoV-2).  It later spread to many nations and the World Health Organisation declared it a pandemic on 12 March 2020. As the health crisis was looming all over the world with thousands reported to have contracted the disease, some of whom died, the search for various treatment options took great priority. Accordingly repurposing of old and approved drugs such as chloroquine, hydroxychloroquine (HCQ), azithromycin, metformin, angiotensin receptor inhibitors such as sartans, or statins such as simvastatin were considered to be useful for the treatment of this disease. [4] Of these, hydroxychloroquine has garnered much attention as a potential prophylactic / treatment option for COVID-19. 

With mounting evidence on the possible beneficial effect of HCQ in the prevention and treatment of COVID-19, there is limited information on the pop PK of HCQ in an Indian setting when administered for the prophylaxis of COVID-19. Thus, the current study gains greater importance given the current pandemic with COVID-19.

 
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