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

Intermountain Health Care, Inc.1,550 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,550

Conditions

COVID-19

Interventions

HydroxychloroquineDRUG

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.

AzithromycinDRUG

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

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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

Locations (2)

Intermountain Medical Center

Murray, Utah, United States

RECRUITING

University of Utah

Salt Lake City, Utah, United States

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Hospitalization within 14 days of enrollment

Admitted to a hospital (not merely kept for emergency room observation)

Time frame: From enrollment to 14 days after enrollment

Secondary Outcomes

Duration of COVID-19-attributable symptoms

Time frame: From enrollment to 14 days after enrollment

Hospital-free days at 28 days

Hospital-free days at 28 days (number of days patient not in hospital); calculated as worst-rank ordinal with mortality by day 28 assigned the worst score

Time frame: Admission (day 1) to 28 days after admission (day 28)

Ventilator-free days at 28 days

Ventilator-free days at 28 days (number of days patient not on a ventilator); calculated as worst-rank ordinal with mortality by day 28 assigned the worst score

Time frame: Admission (day 1) to 28 days after admission (day 28)

ICU-free days at 28 days

ICU-free days at 28 days, calculated as worst-rank ordinal with mortality by day 28 assigned the worst score

Time frame: Admission (day 1) to 28 days after admission (day 28)

Central Contacts

Valerie T Aston, MBA

CONTACT

8015074606 Valerie.Aston@imail.org

David P Tomer, MS

CONTACT

801-507-4694 David.Tomer@imail.org

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.