Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19
HyAzOUT
1 other identifier
interventional
1,550
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 covid19
Started Apr 2020
Longer than P75 for phase_3 covid19
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2020
CompletedStudy Start
First participant enrolled
April 2, 2020
CompletedFirst Posted
Study publicly available on registry
April 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedApril 9, 2020
April 1, 2020
9 months
April 2, 2020
April 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hospitalization within 14 days of enrollment
Admitted to a hospital (not merely kept for emergency room observation)
From enrollment to 14 days after enrollment
Secondary Outcomes (4)
Duration of COVID-19-attributable symptoms
From enrollment to 14 days after enrollment
Hospital-free days at 28 days
Admission (day 1) to 28 days after admission (day 28)
Ventilator-free days at 28 days
Admission (day 1) to 28 days after admission (day 28)
ICU-free days at 28 days
Admission (day 1) to 28 days after admission (day 28)
Study Arms (2)
Hydroxychloroquine
EXPERIMENTALAzithromycin
ACTIVE COMPARATORInterventions
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.
Patients in the azithromycin arm will receive azithromycin 500mg PO on day 1 plus 250mg PO daily on days 2-5.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Intermountain Health Care, Inc.lead
- University of Utahcollaborator
- Utah Department of Healthcollaborator
Study Sites (2)
Intermountain Medical Center
Murray, Utah, 84107, United States
University of Utah
Salt Lake City, Utah, 84112, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brandon Webb, MD
Intermountain Health Care, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Transplant Infectious Diseases
Study Record Dates
First Submitted
April 2, 2020
First Posted
April 6, 2020
Study Start
April 2, 2020
Primary Completion
December 31, 2020
Study Completion
December 31, 2021
Last Updated
April 9, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share
In order to protect patient privacy and comply with relevant regulations, identified data are unavailable. Requests for deidentified data from qualified researchers with appropriate ethics board approvals and relevant data use agreements will be processed by the Intermountain Office of Research, officeofresearch@imail.org.