| CTRI Number |
CTRI/2020/05/025216 [Registered on: 16/05/2020] Trial Registered Prospectively |
| Last Modified On: |
18/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
HCQ POCKET ECG Ambulatory Telemetry Study |
|
Scientific Title of Study
|
Evaluation of Cardiac Safety of Hydroxychloroquin for pre COVID 19 Exposure Prophylaxis : Smart Remote Continuous Ambulatory Electrocardiographic Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohit Walia |
| Designation |
Assistant Professor Incharge Electrophysiology , Heart Failure Special Clinic |
| Affiliation |
All India Institute of Medical Science Rishikesh |
| Address |
Room number 25103 , Department of Cardiology , All India Institute of Medical Science , Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8800492549 |
| Fax |
|
| Email |
rwalia7731@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Rohit Walia |
| Designation |
Assistant Professor Incharge Electrophysiology , Heart Failure Special Clinic |
| Affiliation |
All India Institute of Medical Science Rishikesh |
| Address |
Room number 25103 , Department of Cardiology , All India Institute of Medical Science , Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8800492549 |
| Fax |
|
| Email |
rwalia7731@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Rohit Walia |
| Designation |
Assistant Professor Incharge Electrophysiology , Heart Failure Special Clinic |
| Affiliation |
All India Institute of Medical Science Rishikesh |
| Address |
Room number 25103 , Department of Cardiology , All India Institute of Medical Science , Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8800492549 |
| Fax |
|
| Email |
rwalia7731@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Principal Investigator , Room number 25103 , Department of Cardiology , All India institute of Medical science, Virbhadra Road , Pashulok , Rishikesh |
|
|
Primary Sponsor
|
| Name |
Rohit Walia |
| Address |
Room number 25103 Department of Cardiology All India Institute of Medical Science Rishikesh |
| Type of Sponsor |
Other [ Principal investigator ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| MEDICALgorithmics |
MEDICALgorithmics India
IndiQube- Octagon
#643,80ft Road 4 th Block Koramangala Banglore - 560034 India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rohit Walia |
All India Institute of Medical science Rishikesh |
Room number 25103 , Department of Cardiology, Virbhadra Road , Pashulok , Rishikesh
Dehradun
UTTARANCHAL |
8800492549
rwalia7731@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Science Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Given pre COVID 19 exposure prophylaxis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
people taking pre exposure COVID 19 hydroxychloroquin prophylaxis
Written informed consent |
|
| ExclusionCriteria |
| Details |
Corrected QT greater than 480 ms
Known congenital Long QT
Co moralities and contraindications to hydroxychloroquin
Retinopathy
Known hypersensitivity to chloroquine
Cardiomyopathy, prolonged QTc, cardiac arrhythmias • History of psoriasis, porphyria cutanea tarda
Epilepsy
Myasthenia gravis, myopathy of any cause
Serious hepatic or renal disease
Known glucose-6-phosphate dehydrogenase deficiency
Current use of medication with known serious hepatotoxic effects or known interaction with chloroquine
Severe depression
Electrolyte imbalance
Anti arrhythmic drugs
Cardiac devices like pacemaker , defibrillators |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
No of patients with QT prolongation by 25 percentage of baseline
No of patients with QT prolongation greater than 500 ms
No of patients with ventricular arrhythmias
Syncope
Sudden cardiac Death |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Any drug related adverse events
Any Syncope , all cause mortality |
seven days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "21"
Final Enrollment numbers achieved (India)="21" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/05/2020 |
| Date of Study Completion (India) |
18/01/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
Normal people taking hydroxchloroquin for COVID 19 pre exposure prophylaxis will be monitored through contnous ambulatory telemetry device for any QT prolongation and arrhythmias for continuous seven days from start of medicine to generate cardiac safety data. |