| CTRI Number |
CTRI/2020/05/025242 [Registered on: 19/05/2020] Trial Registered Prospectively |
| Last Modified On: |
18/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Hydroxychloroquine of pharmacokinetics in healthcare workers |
|
Scientific Title of Study
|
Population pharmacokinetics of hydroxychloroquine sulphate in healthcare workers given for prophylaxis against Corona Virus Disease 2019 (COVID 19) pandemic in India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 83341 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nithya Gogtay |
| Designation |
Professor Additional |
| Affiliation |
Department of Clinical Pharmacology |
| Address |
Dept of Clinical Pharmacology 1st floor MS building
Seth GSMC and KEM Hospital Acharya Donde marg Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
njgogtay@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nithya Gogtay |
| Designation |
Professor Additional |
| Affiliation |
Department of Clinical Pharmacology Seth GSMC and KEM Hospital |
| Address |
Dept of Clinical Pharmacology 1st floor MS building
Seth GSMC and KEM Hospital Acharya Donde marg Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
njgogtay@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nithya Gogtay |
| Designation |
Professor Additional |
| Affiliation |
Department of Clinical Pharmacology Seth GSMC and KEM Hospital |
| Address |
Dept of Clinical Pharmacology 1st floor MS building
Seth GSMC and KEM Hospital Acharya Donde marg Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
njgogtay@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V. Ramalingaswami Bhawan
P O Box No 4911
Ansari Nagar New Delhi 110029 India |
| Type of Sponsor |
Government funding agency |
|
|
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 Nihtya Gogtay |
Dept of Clinical Pharmacology |
1st floor Seth GSMC and KEM Hospital Parel Mumbai
Mumbai
MAHARASHTRA |
02224133767
njgogtay@hotmail.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 |
Healthcare workers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hydroxychloroquine sulphate |
Oral tablet 400 mg twice a day on Day 1, followed by 400 mg once weekly for next 7 weeks to be taken with meals |
| Comparator Agent |
Not applicable |
Single arm study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Asymptomatic Health Care workers (HCWs) of any gender and conditions as follows:
age 18 -65 years (HCW who are actively on duty and not any who have retired) on prophylaxis with HCQ against COVID-19 infection – Group 1 without comorbiditie
age 18 -65 years (HCW who are actively on duty and not any who have retired) who are to be initiated on prophylaxis – Group 2 without comorbidities
age 18 -65 years (HCW who are actively on duty and not any who have retired) on prophylaxis with HCQ against COVID-19 infection with comorbidities (HT, Diabetes) – Group3
age 18 -65 years (HCW who are actively on duty and not any who have retired) who are to be initiated on prophylaxis – Group 2 with comorbidities (HT, Diabetes)
|
|
| ExclusionCriteria |
| Details |
Health care workers who show symptoms suggestive of COVID-19 or are positive for COVID-19
Women of child bearing potential who are not willing for adequate contraception during the time of blood collection / who were not practicing adequate contraception in the last 28 days
Women who are pregnant or breast feeding
Participants who are not determined to be fit by the investigator
Participants who are prescribed HCQ for any other indication / history of taking HCQ in the last one year
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The modelling will help assess which of the variables including the presence of comorbidities (if any) would have the greatest impact on the drug concentrations in an Indian population. It would also help us understand if COVID-19 infection alters the pharmacokinetics of HCQ. |
2-8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It would also help us understand the concentrations of HCQ in lung fluid using PBPK modelling |
2-8 weeks |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
25/05/2020 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
After data analysis , study will publish. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Corona Virus Disease 2019 (COVID-19) had its origin in Wuhan, China in December 2019 and was subsequently found to have been caused by a novel corona virus named severe acute respiratory syndrome corona virus 2 (SARS-CoV-2). It later spread to many nations and the World Health Organisation declared it a pandemic on 12 March 2020. As the health crisis was looming all over the world with thousands reported to have contracted the disease, some of whom died, the search for various treatment options took great priority. Accordingly repurposing of old and approved drugs such as chloroquine, hydroxychloroquine (HCQ), azithromycin, metformin, angiotensin receptor inhibitors such as sartans, or statins such as simvastatin were considered to be useful for the treatment of this disease. [4] Of these, hydroxychloroquine has garnered much attention as a potential prophylactic / treatment option for COVID-19. With mounting evidence on the possible beneficial effect of HCQ in the prevention and treatment of COVID-19, there is limited information on the pop PK of HCQ in an Indian setting when administered for the prophylaxis of COVID-19. Thus, the current study gains greater importance given the current pandemic with COVID-19. |