| 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
|
|
|
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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Health care workers on HCQ prophylaxis working in covid hospitals |
|
|
Intervention / Comparator Agent
|
|
|
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.
|