| CTRI Number |
CTRI/2020/05/025089 [Registered on: 09/05/2020] Trial Registered Prospectively |
| Last Modified On: |
29/03/2022 |
| 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
|
|
|
Primary Sponsor
|
| Name |
SGPGIMS |
| Address |
SGPGIMS, Raebareli Road,
Lucknow (UP)
226014
India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
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
|
|
|
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
|
|
|
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)= "43"
Final Enrollment numbers achieved (India)="43" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/05/2020 |
| Date of Study Completion (India) |
15/09/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/09/2020 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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.
|