Status:
COMPLETED
Pre-exposure Prophylaxis for SARS-Coronavirus-2
Lead Sponsor:
University of Minnesota
Conditions:
COVID-19
Corona Virus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Objective: To determine if pre-exposure prophylaxis with hydroxychloroquine is effective for the prevention of COVID-19 disease.
Detailed Description
The current standard of care is observation and quarantine after exposure to COVID-19. There is no approved treatment or prophylaxis for COVID-19. As of March 6, 2020, the CDC estimates that the tran...
Eligibility Criteria
Inclusion
- \- 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
- 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.
Key Trial Info
Start Date :
April 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 13 2020
Estimated Enrollment :
1483 Patients enrolled
Trial Details
Trial ID
NCT04328467
Start Date
April 6 2020
End Date
July 13 2020
Last Update
July 2 2021
Active Locations (2)
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1
Nationwide Enrollment via Internet, please email: covid19@umn.edu
Minneapolis, Minnesota, United States, 55455
2
University of Minnesota
Minneapolis, Minnesota, United States, 55455