Pre-exposure Prophylaxis for SARS-Coronavirus-2

• Status: Completed
• Trial end date: 2020-07-13
• Target enrollment: 0
• Participant gender: All

Summary

Objective: To determine if pre-exposure prophylaxis with hydroxychloroquine is effective for the prevention of COVID-19 disease.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota
• Treatments: Hydroxychloroquine

Criteria

Inclusion Criteria:

• A healthcare worker at high risk for COVID-19 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 (CRNAs)

• First responders (i.e. EMTs, paramedics)

Exclusion Criteria:

• Active COVID-19 disease

• Prior COVID-19 disease

• Current fever, cough, shortness of breath

• Allergy to chloroquine or hydroxychloroquine

• 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

• Prolonged QT syndrome

• Current use of hydroxychloroquine, chloroquine, or cardiac medicines of flecainide, amiodarone, digoxin, procainamide, or propafenone

• Current use of medications with known significant drug-drug interactions: artemether, lumefantrine, mefloquine, tamoxifen, or methotrexate.