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

Purpose

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.

Condition

  • COVID-19

Eligibility

Eligible Ages
Over 45 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Hydroxychloroquine
  • 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.
Active Comparator
Azithromycin
  • Drug: Azithromycin
    Patients in the azithromycin arm will receive azithromycin 500mg PO on day 1 plus 250mg PO daily on days 2-5.

Recruiting Locations

Intermountain Medical Center
Murray, Utah 84107
Contact:
Valerie T Aston, MBA
801-507-4606
Valerie.Aston@imail.org

More Details

NCT ID
NCT04334382
Status
Unknown status
Sponsor
Intermountain Health Care, Inc.

Study Contact

Valerie T Aston, MBA
8015074606
Valerie.Aston@imail.org