Efficacy of Various Doses of Hydroxychloroquine in Pre-Exposure Prophylaxis for COVID 19

• Status: Recruiting
• Trial end date: 2020-09-25
• Target enrollment: 0
• Participant gender: All

Summary

Hydroxychloroquine has been approved by FDA as one of the treatment options for COVID 19.Healthcare personnel are amongst those at highest risk to contract the disease. Several health authorities are now recommending the use of hydroxychloroquine as pre-exposure prophylaxis is in health care personnel. Several studies are on going in this context. However there is a controversy regarding the dosage regimen. This drug has a half life of 22.4 days. In this study we will be comparing three different doses of Hydroxychloroquine and additionally have a control group in order to determine the efficacy of hydroxychloroquine as pre- exposure prophylaxis in healthcare personnel in various doses.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shaheed Zulfiqar Ali Bhutto Medical University
• Treatments: Hydroxychloroquine

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