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CTRI Number  CTRI/2020/05/025010 [Registered on: 04/05/2020] Trial Registered Prospectively
Last Modified On: 04/05/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Hydroxychloroquine prophylaxis in Covid 19 infection 
Scientific Title of Study   Generic Protocol on Hydroxychloroquine Prophylaxis for COVID-19 Infection Among Healthcare Workers: A Proof-of-Concept, Observational Study 
Trial Acronym  HCQPRo 
Secondary IDs if Any  
Secondary ID  Identifier 
HCQ Pro Study Protocol Version 1.3, Dated 20th April, 2020  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Suman Kanungo 
Designation  Scientist E 
Affiliation  Indian council of Medical Research 
Address  Indian Council of Medical Research,HQ office V Ramalingaswami Bhavan, New Delhi

New Delhi
DELHI
110029
India 
Phone  9903824322  
Fax    
Email  sumankanungo@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Madhavi Eerike 
Designation  Scientist D 
Affiliation  Indian council of Medical Research 
Address  Indian Council of Medical Research,HQ office V Ramalingaswami Bhavan, New Delhi

New Delhi
DELHI
110029
India 
Phone  9941476332  
Fax    
Email  dr.madhavieerike@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pranab Chatterjee  
Designation  Scientist B 
Affiliation  Indian council of Medical Research 
Address  Indian Council of Medical Research,HQ office V Ramalingaswami Bhavan, New Delhi

New Delhi
DELHI
110029
India 
Phone  8910212173  
Fax    
Email  pranab.chatterjee@phi.org.in  
 
Source of Monetary or Material Support  
ICMR 
 
Primary Sponsor  
Name  Indian council of Medical Research 
Address  Indian council of Medical Research, V Ramalingaswami Bhavan, AIIMS campus, New Delhi 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vikas Bhatia  AIIMS Bhubaneswar  Sijua, Patrapada, Bhubaneswar
Khordha
ORISSA 
9438884000

bhatiaaiims@gmail.com 
Prof Pankaja Raghav  AIIMS Jodhpur  Basni Industrial Area, MIA 2nd Phase, Basni, Jodhpur,
Jodhpur
RAJASTHAN 
8003996904

raghavpankaja3@gmail.com 
Dr Neeraj Agarwal  AIIMS PATNA  Patna - Aurangabad Rd, Phulwari Sharif, Patna
Patna
BIHAR 
9771913197

neeraj502@rediffmail.com 
Dr Dorairajan Sureshkumar  Apollo Hospitals  Apollo Hospitals Chennai
Chennai
TAMIL NADU 
9444186807

dskinfdis@gmail.com 
Dr Suneela Garg  Maulana Azad Medical college and associated Lok Nayak Hospita  2, Bahadur Shah Zafar Marg, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi,
New Delhi
DELHI 
9810043707

gargsuneela@gmail.com 
Dr Atul gogia  Sir Ganga Ram Hospital  Sarhadi Gandhi Marg, Old Rajinder Nagar, Rajinder Nagar, New Delhi
New Delhi
DELHI 
9891003450

atulgogs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
AIIMS Bhubaneswar  Submittted/Under Review 
ICMR Covid 19 National Ethics Committee  Approved 
IEC AIIMS PATNA  Approved 
IEC Apollo Hospitals Chennai  Submittted/Under Review 
IEC Jodhpur  Submittted/Under Review 
IEC MAMC  Submittted/Under Review 
IEC SIr Gangaram Hospital  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Health care workers on HCQ prophylaxis working in covid hospitals 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All healthcare workers (including doctors, nurses, and other hospital staff) employed by COVID-19 dedicated hospitals, irrespective of their HCQ consumption status, who test negative at the baseline and consent to be included in the study will be eligible for recruitment in the study 
 
ExclusionCriteria 
Details  Healthcare workers who are pregnant or lactating will be excluded based on self-declaration of such status at the baseline evaluation. Those who do not consent to participate will also be excluded. If tested to be COVID-19 positive at baseline, the healthcare worker will be excluded from the study, isolated and managed under standard treatment protocols.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The proportion of healthcare workers who likely contracted COVID-19 infection from a nosocomial source in the 12-week period during which they were under HCQ prophylaxis   Every week for 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
The proportion of healthcare workers who develop adverse drug reactions in the 12-week period during which they were under HCQ prophylaxis   Every week for 12 weeks 
 
Target Sample Size   Total Sample Size="2000"
Sample Size from India="2000" 
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)   04/05/2020 
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="0"
Months="6"
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  

The current study is being designed as a proof-of-concept, observational study to establish the effectiveness of a weekly prophylactic regime of hydroxychloroquine as per ICMR guidelines in prevention of COVID-19 in healthcare workers in the setting of the COVID-19 epidemic. The objectives are to estimate incidence rate of SARS-CoV-2 infection as well as side effects produced among HCWs who were/are undertaking HCQ prophylaxis.

The study would be conducted in those hospitals which are dedicated to manage COVID-19 cases. All healthcare workers (including doctors, nurses, paramedical, lab technicians, sanitary workers and others) irrespective of their HCQ consumption status, who test negative at the baseline and willing to give consent will be included in the study. The study will be done for duration of 12 weeks after the recruitment of the final participant with expected duration of study is 4 months. Data will be collected using structured questionnaire which includes exposure history, symptom history, testing details, Comorbidities, prophylaxis details.

 

 
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