A randomized controlled trial of hydroxychloroquine prophylaxis for Healthcare Workers exposed to COVID-19
Not Applicable
Completed
- Registration Number
- CTRI/2020/05/025067
- Lead Sponsor
- George Institute for Global Health India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 416
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 1. hospitalization due to suspected COVID-19 disease, <br/ ><br>2. admission with suspected COVID-19 to either an ICU or HDU , <br/ ><br>3. all-cause mortality, <br/ ><br>4.organ failure <br/ ><br>5. duration of ICU or HDU stay, <br/ ><br>6. Need for vasopressors <br/ ><br>7. Need for renal replacement <br/ ><br>8. duration of hospitalization, <br/ ><br>9. readmission to hospital <br/ ><br>10.days off workTimepoint: From randomization till the study end