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CTRI Number  CTRI/2020/06/025593 [Registered on: 04/06/2020] Trial Registered Prospectively
Last Modified On: 03/06/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to determine relative efficacy of hydroxy-chloroquine prophylaxis to healthcare-professionals for Covid-19 mitigation 
Scientific Title of Study   “Relative efficacy of hydroxy-chloroquine prophylaxis to healthcare-professionals for Covid-19 mitigation: a pragmatic prospective observational study (RE-HCP2 COVID study)” 
Trial Acronym  RE-HCP2 COVID study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prasan Kumar Panda 
Designation  Assistant Professor  
Affiliation  AIIMS Rishikesh 
Address  Department of General Medicine, Sixth floor, College block, AIIMS Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9868999488  
Fax    
Email  prasan.med@aiimsrishiekesh.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Prasan Kumar Panda 
Designation  Assistant Professor  
Affiliation  AIIMS Rishikesh 
Address  Department of General Medicine, Sixth floor, College block, AIIMS Rishikesh


UTTARANCHAL
249203
India 
Phone  9868999488  
Fax    
Email  prasan.med@aiimsrishiekesh.edu.in  
 
Details of Contact Person
Public Query  
Name  Prasan Kumar Panda 
Designation  Assistant Professor  
Affiliation  AIIMS Rishikesh 
Address  Department of General Medicine, Sixth floor, College block, AIIMS Rishikesh


UTTARANCHAL
249203
India 
Phone  9868999488  
Fax    
Email  prasan.med@aiimsrishiekesh.edu.in  
 
Source of Monetary or Material Support  
Research cell, AIIMS, Rishikesh, Uttarakhand, 249203  
 
Primary Sponsor  
Name  AIIMS Rishikesh 
Address  Research cell, AIIMS, Rishikesh, Uttarakhand, 249203 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NILL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prasan Kumar Panda  AIIMS  Department of General Medicine, Sixth floor, College Block, AIIMS Rishikesh
Dehradun
UTTARANCHAL 		 9868999488

prasan.med@aiimsrishiekesh.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, AIIMS Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthcare-professionals 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Any Asymptomatic Medical professional (MP) of either sex (including pregnant and lactating female), >18 years of age and > 45 kg of weight, based in a primary, secondary or tertiary healthcare setting, who is already taking or willing to take chloroquine prophylaxis in anticipation of high risk of developing COVID-19 due to his/her potential exposure to patients with SARS-CoV-2 infection or having risk of this infection.
2.Special inclusion of MPs for case control arm will be:
a.Those who are reluctant to take any prophylaxis
b.MP with history of the following conditions: Retinopathy or retinal disease; Cardiomyopathy; Cardiac arrhythmia; Prolonged QTc; Psoriasis; Porphyria cutanea tarda; Epilepsy; Myasthenia gravis; Myopathy of any cause; Serious hepatic or renal disease; Glucose-6-phosphate dehydrogenase deficiency (G6PD); Severe depression which prevent chloroquine use
c.Self-reported current use of medication with known serious hepatotoxic effects or known interaction with chloroquine/ hydroxychloroquine as listed in appendix 3 which prevent chloroquine use.
 
 
ExclusionCriteria 
Details  1.Weight outside range 45 kg – 150 kg (99 lbs – 330 lbs).
2.Prior enrolment into this observational study.
3.Self-reported or diagnosed infection with SARS-CoV-2 or previous COVID-19 diagnosis within the last 6 months.
4.Self-reported current acute respiratory infection
5.Inability or unwillingness to be followed up for the trial period
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
(1) Incidence of Symptomatic COVID-19 in each one of 4 arms;
Clinical diagnosis of COVID-19 with virology confirmation, with limitation of activities (WHO Severity Scale 2-8) over the study enrolment period.
(2) Incidence of Peak severity of COVID-19 over the study period in COVID-19 positive MPs
 		 at multiple intervals over 3months 
 
Secondary Outcome  
Outcome  TimePoints 
(1)The incidence of: pneumonia; respiratory failure requiring intubation; acute respiratory distress syndrome; delirium; shock requiring vasopressor medications; sepsis; acute kidney injury; acute liver injury; death. Case definitions will be decided a priori.
(2)Duration of intensive care unit stay, hospital day.
(3)Population pharmacokinetic evaluation based on sparse sampling methodology if possible.
 		 30days 
 
Target Sample Size   Total Sample Size="3000"
Sample Size from India="3000" 
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)   12/06/2020 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
An effective and safe prophylaxis or mitigation therapy could change the complexion of COVID-19, altering the extent and severity of infection, and buying time for production of effective vaccines.
 
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