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

I

Intermountain Health Care, Inc.

Status and phase

Unknown
Phase 3

Conditions

COVID-19

Treatments

Drug: Hydroxychloroquine
Drug: Azithromycin

Study type

Interventional

Funder types

Other

Identifiers

NCT04334382
1051360

Details and patient eligibility

About

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.

Enrollment

1,550 estimated patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

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

  • Participants already prescribed chloroquine, hydroxychloroquine, or azithromycin
  • Allergy to hydroxychloroquine or azithromycin
  • History of bone marrow transplant
  • Known G6PD (Glucose-6-Phosphate Dehydrogenase Deficiency) deficiency
  • Chronic hemodialysis, peritoneal dialysis, continuous renal replacement therapy or Glomerular Filtration Rate < 20ml/min/1.73m2
  • Liver disease (e.g. Child Pugh score ≥ B or AST (Aspartate Transaminase)>2 times upper limit)
  • Psoriasis
  • Porphyria
  • Known cardiac conduction delay (QTc > 500mSec) or taking any prescription medications known to prolong QT interval
  • Concomitant use of digitalis, flecainide, amiodarone, procainamide, or propafenone
  • Prisoner
  • 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
  • No symptoms attributable to COVID-19
  • Pregnant or nursing

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,550 participants in 2 patient groups

Hydroxychloroquine
Experimental group
Treatment:
Drug: Hydroxychloroquine
Azithromycin
Active Comparator group
Treatment:
Drug: Azithromycin

Trial contacts and locations

2

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Central trial contact

Valerie T Aston, MBA; David P Tomer, MS

Data sourced from clinicaltrials.gov

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