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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04334382
Recruitment Status : Recruiting
First Posted : April 6, 2020
Last Update Posted : April 9, 2020
Sponsor:
Collaborators:
University of Utah
Utah Department of Health
Information provided by (Responsible Party):
Brandon Webb, Intermountain Health Care, Inc.

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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Hydroxychloroquine Drug: Azithromycin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19 (HyAzOUT): A Prospective Pragmatic Trial
Actual Study Start Date : April 2, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Hospitalization within 14 days of enrollment [ Time Frame: From enrollment to 14 days after enrollment ]
    Admitted to a hospital (not merely kept for emergency room observation)


Secondary Outcome Measures :
  1. Duration of COVID-19-attributable symptoms [ Time Frame: From enrollment to 14 days after enrollment ]
  2. Hospital-free days at 28 days [ Time Frame: Admission (day 1) to 28 days after admission (day 28) ]
    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

  3. Ventilator-free days at 28 days [ Time Frame: Admission (day 1) to 28 days after admission (day 28) ]
    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

  4. ICU-free days at 28 days [ Time Frame: Admission (day 1) to 28 days after admission (day 28) ]
    ICU-free days at 28 days, calculated as worst-rank ordinal with mortality by day 28 assigned the worst score



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04334382


Contacts
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Contact: Valerie T Aston, MBA 8015074606 Valerie.Aston@imail.org
Contact: David P Tomer, MS 801-507-4694 David.Tomer@imail.org

Locations
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United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84107
Contact: Valerie T Aston, MBA    801-507-4606    Valerie.Aston@imail.org   
Contact: Jake Krong    801-507-9333    Jake.Krong@imail.org   
University of Utah Not yet recruiting
Salt Lake City, Utah, United States, 84112
Contact: Estelle Harris, MD    801-581-7806      
Sponsors and Collaborators
Intermountain Health Care, Inc.
University of Utah
Utah Department of Health
Investigators
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Principal Investigator: Brandon Webb, MD Intermountain Health Care, Inc.
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Responsible Party: Brandon Webb, Director, Transplant Infectious Diseases, Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT04334382    
Other Study ID Numbers: 1051360
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brandon Webb, Intermountain Health Care, Inc.:
SARS-Co-V-2
Hydroxychloroquine
Azithromycin
Additional relevant MeSH terms:
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Azithromycin
Hydroxychloroquine
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents