A randomized controlled trial of hydroxychloroquine prophylaxis for Healthcare Workers exposed to COVID-19

• Register: CTRI
• Last refreshed on: 17 October 2022
• Main ID: CTRI/2020/05/025067
• Date of registration: 06-05-2020
• Prospective Registration: Yes
• Primary sponsor: George Institute for Global Health India
• Public title: A randomized controlled trial of hydroxychloroquine prophylaxis for Healthcare Workers exposed to COVID-19
• Scientific title: A randomized controlled trial of hydroxychloroquine prophylaxis for Healthcare Workers exposed to COVID-19
• Date of first enrolment: 15-06-2020
• Target sample size: 6950
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43019
• Study type: Interventional
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Professor Vivekanand Jha
• Affiliation: The George Institute for Global Health, India

• Name: Professor Vivekanand Jha
• Affiliation: The George Institute for Global Health, India

Key inclusion & exclusion criteria

Inclusion criteria: All HCWs directly exposed to confirmed COVID-19 patients.
Exclusion criteria: Participants who meet any of following criteria will be are excluded

1. have a proven diagnosis of COVID-19 infection

2. are currently taking chloroquine or HCQ

3. are pregnant

4. are breast feeding

5. known QT prolongation

6. history of serious cardiac dysrhythmias or cardiomyopathy

7. have maculopathy of the eye (a contra-indication to HCQ)

8. are immunocompromised because of a disease or therapy

9. pregnant women

Age minimum:
Age maximum:
Gender:

Intervention(s)

Intervention1: hydroxychloroquine along with Standard care Personal protective equipment: 800 mg of hydroxychloroquine on the day of enrollment and 400mg once a week after that for a total of 12 weeks
along with standard care Personal protective equipment
Control Intervention1: Standard care Personal protective equipment: standard care Personal protective equipment

Primary Outcome(s)

Proportion of laboratory confirmed symptomatic COVID-19 cases between the groups at the end of 6 monthsTimepoint: Proportion of laboratory confirmed symptomatic COVID-19 cases between the groups at the end of 6 months

Secondary Outcome(s)

1. hospitalization due to suspected COVID-19 disease,

2. admission with suspected COVID-19 to either an ICU or HDU ,

3. all-cause mortality,

4.organ failure

5. duration of ICU or HDU stay,

6. Need for vasopressors

7. Need for renal replacement

8. duration of hospitalization,

9. readmission to hospital

10.days off workTimepoint: From randomization till the study end

Secondary ID(s)

NIL

Source(s) of Monetary Support

George Institute for Global Health India

Ethics review

Status: Approved
Approval date: 22/06/2020
Contact:

Institutional Ethics Committee Apollo Hospital,Chennai,Tamil Nadu

Status: Approved
Approval date: 23/06/2020
Contact:

The George Institute Ethics Committee

Status: Approved
Approval date: 26/06/2020
Contact:

Christian Hospital, Nabarangpur Odisha

Status: Approved
Approval date: 20/07/2020
Contact:

Institutional Ethics Committee Apollo Hospital, NewDelhi

Status: Approved
Approval date: 27/07/2020
Contact:

Institutional Ethics Committee Biomedical Research, Apollo Hospital, Hyderabad

Status: Approved
Approval date: 03/08/2020
Contact:

Institutional Ethics Committee Apollo Hospital international ltd,Gandhinagar

Status: Approved
Approval date: 17/08/2020
Contact:

Institutional Ethics Committee clinical studies,Apollo Speciality Hospitals,Madurai

Status: Approved
Approval date: 09/09/2020
Contact:

Kasturba medical college institutional ethics committee,Manipal

Status: Approved
Approval date: 10/10/2020
Contact:

Jawaharlal Nehru medical college and Hospital,AMU,Aligarh,U.P

Results

• Date Completed: 29/07/2021