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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.