Objective: To determine if pre-exposure prophylaxis with hydroxychloroquine is effective for the prevention of COVID-19 disease.
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 transmission of SARS-CoV2 after a U.S.
household close contract is 10.5% (95%CI, 2.9 to 31.4%). Among all close contacts, the
SARS-CoV2 transmission rate is estimated at 0.45% (95%CI, 0.12 to 1.6%) by the CDC. These
estimates are based on monitoring of travel-associated COVID19 cases. Conversely, in a
setting with community transmission, the secondary attack rate in China was 35% (95%CI,
27-44%) based on 48 transmissions among 137 persons in 9 index patients.
Chloroquine or Hydroxychloroquine may have antiviral effects against SARS-COV2 which may
prevent COVID-19 disease or reduce disease severity. It is not known at what dosing
hydroxychloroquine may be effective for pre-exposure prophylaxis.
Drug: Hydroxychloroquine
Hydroxychloroquine; 200mg tablet; oral
Other Name: Plaquenil
Other: Placebo
Placebo; tablet; oral
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.
Nationwide Enrollment via Internet, please email: covid19@umn.edu
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
Radha Rajasingham, MD, Principal Investigator
University of Minnesota