Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19

COVID-19 Clinical Trial

— HAHPS  

Official title:

Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19 (HAHPS): A Prospective Pragmatic Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04329832
• Other study ID #: 1051355
• Status: Completed
• Phase: Phase 2
• Start date: March 30, 2020
• Est. completion date: January 1, 2021

Study information

• Verified date: April 2022
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• 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 hospitalized patients with suspected or confirmed COVID-19.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: January 1, 2021
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult (age = 18 years)

• Confirmed OR suspected COVID-19,

• Confirmed: Positive assay for COVID-19 within the last 10 days

• Suspected: Pending assay for COVID-19 WITH high clinical suspicion

• Scheduled for admission or already admitted to an inpatient bed

Exclusion Criteria:

• Allergy to hydroxychloroquine or azithromycin

• History of bone marrow transplant

• Known G6PD deficiency

• Chronic hemodialysis or Glomerular Filtration Rate < 20ml/min

• Psoriasis

• Porphyria

• Concomitant use of digitalis, flecainide, amiodarone, procainamide, propafenone, cimetidine, dofetilide, phenobarbital, phenytoin, or sotalol

• Known history of long QT syndrome

• Current known QTc>500 msec

• Pregnant or nursing

• Prisoner

• Weight < 35kg

• Seizure disorder

• Severe liver disease

• Outpatient use of hydroxychloroquine for treatment of a disease other than COVID-19 OR has received more than 2 days of hydroxychloroquine or azithromycin for suspected or confirmed COVID-19

• Patient has recovered from COVID-19 and/or is being discharged from the hospital on day of enrollment.

• Treating physician refuses to allow patient participation in the study

• Unable to obtain informed consent

• Prior enrollment in this study

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Hydroxychloroquine
Patients in the hydroxychloroquine arm will receive hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 4 days (dose reductions for weight < 45 kg or GFR (glomerular filtration rate)<50ml/min). For patients < 45kg, doses will be halved. For patients with GFR<50ml/min, the final dose of hydroxychloroquine will not be administered. If the patient has already received hydroxychloroquine prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.
• Azithromycin
Patients in the azithromycin arm will receive azithromycin 500 mg on day 1 plus 250 mg daily on days 2-5 (may be administered intravenously per clinician preference). If the patient has already received azithromycin prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.

Locations

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

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

References & Publications (1)

WHO, 2020. WHO R&D Blueprint, novel Coronavirus, COVID-19 Therapeutic Trial Synopsis. https://www.who.int/publications/i/item/covid-19-therapeutic-trial-synopsis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COVID Ordinal Outcomes Scale at 14 Days	Improvement of clinical condition of the patient defined by the COVID-19 WHO ordinal Outcomes score. This scale reflects a range from uninfected to dead, where 0 is "no clinical or virological evidence of infection", 1 is "no limitation of activities", 2 is "limitation of activities", 3 is "hospitalized, no oxygen therapy", 4 is "oxygen by mask or nasal prongs", 5 is "non-invasive ventilation or high-flow oxygen", 6 is "intubation and mechanical ventilation", 7 is "ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)", and 8 is "death".	Assessed once on day 14 after enrollment (enrollment is day 0)
Secondary	Hospital-free Days at 28 Days	Calculated as number of days patient not in hospital	Admission (day 1) to 28 days after admission (day 28)
Secondary	Ventilator-free Days at 28 Days (Number of Days Patient Not on a Ventilator)	Calculated as number of days that patient is not on a ventilator up to day 28 days after admission	Admission (day 1) to 28 days after admission (day 28)
Secondary	ICU-free Days at 28 Days	Calculated as number of days patient not in an ICU	Admission (day 1) to 28 days after admission (day 28)
Secondary	Time to a 1-point Decrease in the WHO Ordinal Recovery Score	Time to 1-point decrease in the WHO ordinal recovery score is defined as the number of days until the ordinal outcome score drops by 1 relative to baseline on the 8-point WHO COVID Ordinal Outcomes scale, which reflects a range from uninfected to dead, where 0 is "no clinical or virological evidence of infection", 1 is "no limitation of activities", 2 is "limitation of activities", 3 is "hospitalized, no oxygen therapy", 4 is "oxygen by mask or nasal prongs", 5 is "non-invasive ventilation or high-flow oxygen", 6 is "intubation and mechanical ventilation", 7 is "ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)", and 8 is "death".	Admission (day 1) to 14 days after admission (day 14)

External Links

•   Source for WHO COVID Ordinal Outcomes Scale