Study Details | University of Minnesota COVID-19 Pre-Exposure Prophylaxis Clinical Trial

The purpose of this research study is to determine if taking the medication hydroxychloroquine can prevent a person who is at high risk to be exposed to the coronavirus from becoming ill and possibly reducing the severity of illness. Importantly, we do not know if this medicine will be effective at preventing disease. To determine if hydroxychloroquine is an effective medication in preventing disease in those exposed to the coronavirus, we will compare the effectiveness of hydroxychloroquine to a medication that has no effects on the coronavirus. If effective, this may become a worldwide standard of care helping prevent disease in other healthcare workers and people exposed around the world.

If you consent to participate, we will ask you to:

Agree to be randomly assigned to receive hydroxychloroquine or a vitamin. If you agree to this study, there would be a 33% chance of receiving a vitamin instead of hydroxychloroquine. Some will take the medicine (hydroxychloroquine or vitamin) once a week, others will be assigned to take it twice a week.
Take the study medicine for the duration of the study (up to 12 weeks):
- 400mg once weekly (with a loading dose)
- 400mg twice weekly (with a loading dose)

Answer short follow up email surveys:
- Day 1 (to confirm you have received the medicines)
- Weekly
- At the end of the trial
- If you become ill or are hospitalized, we would ask to contact you to determine how long your illness lasts.

The hydroxychloroquine dose in this study is similar to what is given for malaria prophylaxis. It is a very safe medicine when used for short periods. The most common side effect is upset stomach and is usually mild. Other side effects reverse when stopping. Serious side effects can occur, but generally only when taken for extended periods, generally >1 year of continuous use.