Pre-exposure Prophylaxis for SARS-Coronavirus-2

Completed · Phase 3 · Has a placebo group

Conditions studied: COVID-19, Corona Virus Infection, ARDS, Acute Respiratory Distress Syndrome

In brief

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

Key facts

Study ID: NCT04328467
Run by: University of Minnesota
People needed: 1483
Starts: 2020-04-06
Expected to finish: 2020-07-13
Last updated by the study team: 2021-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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.

Where it is running

Nationwide Enrollment via Internet, please email: covid19@umn.edu — Minneapolis, Minnesota, United States
University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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