Efficacy of Various Doses of Hydroxychloroquine in Pre-Exposure Prophylaxis for COVID 19 (CHEER)
COVID 19
About this trial
This is an interventional prevention trial for COVID 19 focused on measuring pre-exposure prophylaxis, Healthcare personnel
Eligibility Criteria
Inclusion Criteria after taking a written informed consent:
A healthcare worker at high risk for COVID19 exposure (defined below):
- Persons primarily working in emergency departments (physicians, nurses, ancillary staff, triage personnel) ;
- Persons primarily working in intensive care units (physicians, nurses, ancillary staff, respiratory therapists) ;
- Persons performing aerosol generating procedures (i.e. anesthesiologists, nurse anesthetists, gastroenterologists performing endoscopy, Pulmonologists performing bronchoscopy);
- First responders (i.e. EMTs, paramedics) ;
- Persons working in the departments of General Medicine, Pulmonology, Infectious disease and Isolation wards.
Exclusion Criteria:
- Active COVID-19 disease;
- Confirmed prior COVID-19 disease;
- Current fever, cough, shortness of breath;
- Contraindication or hypersensitivity to chloroquine or hydroxychloroquine ad hypersensitivity to 4-aminoquinoline compounds;
- Pregnancy;
- Lactation;
- Prior retinal eye disease;
- Known Chronic Kidney disease, Stage 4 or 5 or dialysis;
- Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency ;
- Weight <40 kg;
- Current use of chloroquine,hydroxychloroquine or cardiac medicines like flecainide, amiodarone, digoxin, procainamide, or propafenone;
- Current use of medications with known significant drug-drug interactions: artemether, lumefantrine, mefloquine, tamoxifen or methotrexate;
- Current use of medications causing QT interval prolongation like: macrolides,antipsychotics,quinolones,antihistamines,SSRIs,tricyclic antidepressants, antifungals;
- Recent Myocardial Infarction;
- History of Epilepsy
Sites / Locations
- Shaheed Zulfiaqar Ali Bhutto Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
Arm 1
Arm 2
Arm 3
Arm 4
Hydroxychloroquine Sulphate will be administered at a dose of 400mg twice a day on day 1 followed by 400 mg once a week for a total of 12 weeks
Hydroxychloroquine Sulphate will be admoinistered at a dose of 400 mg on day 1 followed by 400mg once every 3 weeks for at total of 12 weeks
Hydroxychloroquine Sulphate will be administered at a dose of 200 mg on day 1 followed by 200 mg once every 3 weeks for a total of 12 weeks
Control group will recieve Placebo 200mg on day 1 followed by Placebo 200mg every three weeks for 12 weeks