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CTRI Number  CTRI/2020/05/025089 [Registered on: 09/05/2020] Trial Registered Prospectively
Last Modified On: 11/05/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Effect of Hydroxychloroquine on QTc Interval 
Scientific Title of Study   Effect of Hydroxychloroquine Prophylaxis on QTc Interval of Health Care Workers during COVID-19 Pandemic: An Observational 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 Mohan Gurjar 
Designation  Additional Professor 
Affiliation  Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS) 
Address  Department of Critical Care Medicine, SGPGIMS, Lucknow (UP). 226014 India

Lucknow
UTTAR PRADESH
226014
India 
Phone    
Fax    
Email  m.gurjar@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mohan Gurjar 
Designation  Additional Professor 
Affiliation  Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS) 
Address  Department of Critical Care Medicine, SGPGIMS, Lucknow (UP). 226014 India

Lucknow
UTTAR PRADESH
226014
India 
Phone    
Fax    
Email  m.gurjar@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mohan Gurjar 
Designation  Additional Professor 
Affiliation  Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS) 
Address  Department of Critical Care Medicine, SGPGIMS, Lucknow (UP). 226014 India

Lucknow
UTTAR PRADESH
226014
India 
Phone    
Fax    
Email  m.gurjar@rediffmail.com  
 
Source of Monetary or Material Support  
Non-funded study. 
 
Primary Sponsor  
Name  SGPGIMS 
Address  SGPGIMS, Raebareli Road, Lucknow (UP) 226014 India 
Type of Sponsor  Research institution and hospital 
 
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 Mohan Gurjar  Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)  Department of Critical Care Medicine and Department of Cardiology, SGPGIMS, Raebareli Road, Lucknow, India
Lucknow
UTTAR PRADESH 
05222495403

m.gurjar@rediffmail.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  Health Care Workers taking Hydroxychloroquine chemoprophylaxis as recommended by Indian Council of Medical Research (ICMR) during care of COVID-19 confirmed cases  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All HCWs who have been advised for HCQ as prophylaxis during their posting to manage COVID-19 confirmed or suspected patients. 
 
ExclusionCriteria 
Details  Not on HCQ prophylaxis. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Change in QTc interval  Before and after HCQ prophylaxis 
 
Secondary Outcome  
Outcome  TimePoints 
Baseline QTc interval  Before HCQ prophylaxis 
 
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   N/A 
Date of First Enrollment (India)   18/05/2020 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Hydroxychloroquine (HCQ) has been found to be effective against Corona Virus Disease 2019 (COVID-19) in laboratory studies and it is now recommended as chemoprophylaxis for healthcare workers (HCW) involved in the care of suspected or confirmed cases of COVID-19, by Indian Council of Medical Research (ICMR). HCQ potentially can cause QT interval prolongation in electrocardiogram (ECG). There is no systematic study so far in HCW regarding HCQ in context of this recent COVID-19 pandemic. This is a prospective observational study to know the effect of HCQ, as prescribed for prophylaxis for HCW during COVID-19 pandemic, on the QTc interval in the ECG.


 
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