Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19 (HyAzOUT)
Clara Health

Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19

Sponsored by Intermountain Health Care


This study will compare two drugs (hydroxychloroquine and azithromycin) to see if hydroxychloroquine is better than azithromycin in treating outpatients with suspected or confirmed COVID-19.

About 
COVID-19

Coronavirus disease 2019 (COVID-19) is a respiratory illness that can spread from person to person. The virus that causes COVID-19 is a novel coronavirus that was first identified during an investigation into an outbreak in Wuhan, China.

How is this study designed?

Study Type: Interventional (Clinical Trial) Estimated Enrollment: 1550 participants Primary Purpose: Treatment Official Title: Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19 (HyAzOUT): A Prospective Pragmatic Trial Actual Study Start Date: April 2, 2020 Estimated Study Completion Date: December 31, 2021

Who is this study for?

Inclusion Criteria*:

  • Adult, Age>44 years, competent to provide consent
  • Confirmed COVID-19, via a positive nucleic acid assay for COVID-19 within the last 7 days

Exclusion Criteria*:

  • Weight < 35kg
  • Inability to follow-up - no cell phone or no address or not Spanish or English speaking
  • Receipt of any experimental treatment for SARS-CoV-2 (off-label, compassionate use, or trial related) within the 30 days prior to the time of the screening evaluation
  • Pregnant or nursing

* Additional criteria apply. Please speak with the study team for further information.

What should I expect?

Arm 1: Hydroxychloroquine Patients in the hydroxychloroquine arm will receive hydroxychloroquine 400mg po BID x 1 day, then 200mg po BID x 4 days (dose reductions for weight < 45kg). The drug dose (2.4 gm over 5 days) chosen falls at the lower end of doses proposed in various international trials, but it has proven in vitro efficacy, with a ratio of lung tissue trough concentrations to the EC50 (effective concentration to suppress 50% of viral activity) of >20.

Arm 2: Azithromycin Patients in the azithromycin arm will receive azithromycin 500mg PO on day 1 plus 250mg PO daily on days 2-5.

outpatient trial premium listing

Have questions or need help?

For general questions about COVID-19 clinical trials, please email [email protected] For study specific inquiries, submit the interest form and you'll be connected to the team.