NCT04334382

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

Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19 (HyAzOUT): A Prospective Pragmatic Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,550 (estimated)
• Sponsor: Intermountain Health Care, Inc. · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	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.
DRUG	Azithromycin	Patients in the azithromycin arm will receive azithromycin 500mg PO on day 1 plus 250mg PO daily on days 2-5.

Timeline

• Start date: 2020-04-02
• Primary completion: 2020-12-31
• Completion: 2021-12-31
• First posted: 2020-04-06
• Last updated: 2020-04-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study