Recruiting
Phase 3

Hydroxychloroquine vs. Azithromycin

Sponsor:

Intermountain Health Care, Inc.

Code:

NCT04334382

Conditions

COVID-19

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Interventions

Hydroxychloroquine

Azithromycin

Study Details

Brief 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

Study ID

NCT04334382

Start date

Apr 2, 2020

Status verified date

Apr, 2020

Completion date

Dec 31, 2021

Anticipated

Primary completion date

Dec 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

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

Enrollment

1550 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hydroxychloroquine

active comparator: Azithromycin

Interventions

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.

Azithromycin

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

Primary outcome measure

  • Hospitalization within 14 days of enrollment [ Time Frame: From enrollment to 14 days after enrollment ]

Central Contacts and Locations

Central contacts

Valerie T Aston, MBA

8015074606Valerie.Aston@imail.org

David P Tomer, MS

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

Locations

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84107

Contacts

Valerie T Aston, MBA

801-507-4606Valerie.Aston@imail.org

Jake Krong

801-507-9333Jake.Krong@imail.org

More Information

Sponsor

Intermountain Health Care, Inc.

Last update posted

Apr 9, 2020

Last verified

Apr, 2020

Keywords

  • SARS-Co-V-2
  • Hydroxychloroquine
  • Azithromycin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Intermountain Health Care, Inc. on 2020-04-09.