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

Primary Purpose

COVID-19

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Hydroxychloroquine
Azithromycin
Sponsored by
Intermountain Health Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring SARS-Co-V-2, Hydroxychloroquine, Azithromycin

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Intermountain Medical CenterRecruiting
  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hydroxychloroquine

Azithromycin

Arm Description

Outcomes

Primary Outcome Measures

Hospitalization within 14 days of enrollment
Admitted to a hospital (not merely kept for emergency room observation)

Secondary Outcome Measures

Duration of COVID-19-attributable symptoms
Hospital-free days at 28 days
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
Ventilator-free days at 28 days
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
ICU-free days at 28 days
ICU-free days at 28 days, calculated as worst-rank ordinal with mortality by day 28 assigned the worst score

Full Information

First Posted
April 2, 2020
Last Updated
April 7, 2020
Sponsor
Intermountain Health Care, Inc.
Collaborators
University of Utah, Utah Department of Health
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1. Study Identification

Unique Protocol Identification Number
NCT04334382
Brief Title
Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19
Acronym
HyAzOUT
Official Title
Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19 (HyAzOUT): A Prospective Pragmatic Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Intermountain Health Care, Inc.
Collaborators
University of Utah, Utah Department of Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
SARS-Co-V-2, Hydroxychloroquine, Azithromycin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1550 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hydroxychloroquine
Arm Type
Experimental
Arm Title
Azithromycin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
Patients in the azithromycin arm will receive azithromycin 500mg PO on day 1 plus 250mg PO daily on days 2-5.
Primary Outcome Measure Information:
Title
Hospitalization within 14 days of enrollment
Description
Admitted to a hospital (not merely kept for emergency room observation)
Time Frame
From enrollment to 14 days after enrollment
Secondary Outcome Measure Information:
Title
Duration of COVID-19-attributable symptoms
Time Frame
From enrollment to 14 days after enrollment
Title
Hospital-free days at 28 days
Description
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
Time Frame
Admission (day 1) to 28 days after admission (day 28)
Title
Ventilator-free days at 28 days
Description
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
Time Frame
Admission (day 1) to 28 days after admission (day 28)
Title
ICU-free days at 28 days
Description
ICU-free days at 28 days, calculated as worst-rank ordinal with mortality by day 28 assigned the worst score
Time Frame
Admission (day 1) to 28 days after admission (day 28)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valerie T Aston, MBA
Phone
8015074606
Email
Valerie.Aston@imail.org
First Name & Middle Initial & Last Name or Official Title & Degree
David P Tomer, MS
Phone
801-507-4694
Email
David.Tomer@imail.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brandon Webb, MD
Organizational Affiliation
Intermountain Health Care, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valerie T Aston, MBA
Phone
801-507-4606
Email
Valerie.Aston@imail.org
First Name & Middle Initial & Last Name & Degree
Jake Krong
Phone
801-507-9333
Email
Jake.Krong@imail.org
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Estelle Harris, MD
Phone
801-581-7806

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

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

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