Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19
NCT ID: NCT04334382
Last Updated: 2020-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
1550 participants
INTERVENTIONAL
2020-04-02
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hydroxychloroquine
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
Azithromycin
Patients in the azithromycin arm will receive azithromycin 500mg PO on day 1 plus 250mg PO daily on days 2-5.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Confirmed COVID-19, via a positive nucleic acid assay for COVID-19 within the last 7 days
Exclusion Criteria
* 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
45 Years
ALL
No
Sponsors
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University of Utah
OTHER
Utah Department of Health
OTHER
Intermountain Health Care, Inc.
OTHER
Responsible Party
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Brandon Webb
Director, Transplant Infectious Diseases
Principal Investigators
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Brandon Webb, MD
Role: PRINCIPAL_INVESTIGATOR
Intermountain Health Care, Inc.
Locations
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Intermountain Medical Center
Murray, Utah, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Estelle Harris, MD
Role: primary
Other Identifiers
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1051360
Identifier Type: -
Identifier Source: org_study_id
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