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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
healthcare-professionals |
|
Intervention / Comparator Agent
|
|
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. |