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CTRI Number  CTRI/2020/05/025067 [Registered on: 06/05/2020] Trial Registered Prospectively
Last Modified On: 24/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A randomized controlled trial of hydroxychloroquine prophylaxis for Healthcare Workers exposed to COVID-19 
Scientific Title of Study   A randomized controlled trial of hydroxychloroquine prophylaxis for Healthcare Workers exposed to COVID-19 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Professor Vivekanand Jha 
Designation  Executive Director 
Affiliation  The George Institute for Global Health, India  
Address  The George Institute for Global Health, India 311-312, Third Floor, Elegance Tower Plot No. 8, Jasola District Centre

New Delhi
DELHI
110025
India 
Phone  911141588091  
Fax  911141588090  
Email  vjha@georgeinstitute.org.in  
 
Details of Contact Person
Scientific Query
 
Name  Professor Vivekanand Jha 
Designation  Executive Director 
Affiliation  The George Institute for Global Health, India  
Address  The George Institute for Global Health, India 311-312, Third Floor, Elegance Tower Plot No. 8, Jasola District Centre


DELHI
110025
India 
Phone  911141588091  
Fax  911141588090  
Email  vjha@georgeinstitute.org.in  
 
Details of Contact Person
Public Query
 
Name  Professor Vivekanand Jha 
Designation  Executive Director 
Affiliation  The George Institute for Global Health, India  
Address  The George Institute for Global Health, India 311-312, Third Floor, Elegance Tower Plot No. 8, Jasola District Centre


DELHI
110025
India 
Phone  911141588091  
Fax  911141588090  
Email  vjha@georgeinstitute.org.in  
 
Source of Monetary or Material Support  
George Institute for Global Health India 
 
Primary Sponsor  
Name  George Institute for Global Health India 
Address  George Institute for Global Health, India 311-312, Third Floor, Elegance Tower Plot No. 8, Jasola District Centre New Delhi 110025 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bharath Kumar  Apollo Hospitals  21 Greams Lane, Off, Greams Road, Thousand Lights West, Thousand Lights, Chennai, Tamil Nadu 600006
Chennai
TAMIL NADU 
9591100655

bharath@icuconsultants.com 
Dr Micheal John  Christian Hospital, Nabara  NH 201, Nowrangpur, Odisha 764059
Nabarangapur
ORISSA 
918763394532

mjjohn6854@gmail.com 
Dr Vivekanad Jha  The George Institute for Global Health, India  The George Institute for Global Health, India 311-312, Third Floor, Elegance Tower Plot No. 8, Jasola District Centre New Delhi 110025 India
New Delhi
DELHI 
911141588091

vjha@georgeinstitute.org.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Christian Hospital, Nabarangpur Odisha  Approved 
Institutional Ethics Committee Apollo Hospital  Approved 
Institutional Ethics Committee Apollo Hospital,Newdelhi  Approved 
The George Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Prophylaxis with hydroxychloroquine in COVID-19 infections 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  hydroxychloroquine along with Standard care Personal protective equipment  800 mg of hydroxychloroquine on the day of enrollment and 400mg once a week after that for a total of 12 weeks along with standard care Personal protective equipment 
Comparator Agent  Standard care Personal protective equipment  standard care Personal protective equipment 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  All HCWs directly exposed to confirmed COVID-19 patients. 
 
ExclusionCriteria 
Details  Participants who meet any of following criteria will be are excluded
1. have a proven diagnosis of COVID-19 infection
2. are currently taking chloroquine or HCQ
3. are pregnant
4. are breast feeding
5. known QT prolongation
6. history of serious cardiac dysrhythmias or cardiomyopathy
7. have maculopathy of the eye (a contra-indication to HCQ)
8. are immunocompromised because of a disease or therapy
9. pregnant women 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Proportion of laboratory confirmed symptomatic COVID-19 cases between the groups at the end of 6 months  Proportion of laboratory confirmed symptomatic COVID-19 cases between the groups at the end of 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. hospitalization due to suspected COVID-19 disease,
2. admission with suspected COVID-19 to either an ICU or HDU ,
3. all-cause mortality,
4.organ failure
5. duration of ICU or HDU stay,
6. Need for vasopressors
7. Need for renal replacement
8. duration of hospitalization,
9. readmission to hospital
10.days off work 
From randomization till the study end 
 
Target Sample Size
Modification(s)  
Total Sample Size="6950"
Sample Size from India="6950" 
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)   15/06/2020 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Brief Summary  

This study aims to Evaluate whether a strategy of prophylaxis with hydroxychloroquine(HCQ) taken weekly for 3 months reduces the risk of acquiring symptomatic COVID-19 infections among healthcare workers.

There are no human studies of HCQ prophylaxis. The Indian Council of Medical Research in its advisory recommended 400 mg to be taken twice on D1 followed by 400mg once a week for 7 weeks. We anticipate longer durations of exposure for most HCWs working in COVID-19 wards based on current number of cases and expected Indian and International trajectories. We have hence chosen the 12-week prophylaxis duration. Given the reassuring safety data on HCQ, we think 12 weeks is a reasonable and safe duration.

This is a Randomized controlled trial of standard care + HCQ vs standard  care. Standard care is defined as the use of recommended PPE precautions. HCW randomised to the intervention will receive 800 mg stat of HCQ (directly observed) followed by 400mg once a week for 12 weeks.

Potential participants will be referred to the research team by treating physicians and other COVID-19 ward and ICU staff. The research team will confirm eligibility and the principal investigator and coÔÇÉinvestigators will confirm whether the participant can be approached for consent.

At baseline information will be collected on designation, role in COVID ward (nurse, physician, physiotherapist, dietitian, housekeeping personnel etc.), demographics, average shift duration, and comorbidities.

During follow-up data will be collected on proportion of HCWs that develop symptomatic and laboratory confirmed COVID-19 infection (yes/no) and a host of secondary outcomes. 
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