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

COVID-19 Clinical Trial

— HyAzOUT  

Official title:

Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19 (HyAzOUT): A Prospective Pragmatic Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04334382
• Other study ID #: 1051360
• Status: Recruiting
• Phase: Phase 3
• Start date: April 2, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2020
• Source: Intermountain Health Care, Inc.
• Contact: Valerie T Aston, MBA
• Phone: 8015074606
• Email: Valerie.Aston[@]imail.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1550
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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.
• Azithromycin
Patients in the azithromycin arm will receive azithromycin 500mg PO on day 1 plus 250mg PO daily on days 2-5.

Locations

Country	Name	City	State
United States	Intermountain Medical Center	Murray	Utah
United States	University of Utah	Salt Lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.	University of Utah, Utah Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of COVID-19-attributable symptoms		From enrollment to 14 days after enrollment
Secondary	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	Admission (day 1) to 28 days after admission (day 28)
Secondary	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	Admission (day 1) to 28 days after admission (day 28)
Secondary	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	Admission (day 1) to 28 days after admission (day 28)