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

Intermountain Health Care, Inc. logo

Intermountain Health Care, Inc.

Status and phase

Completed
Phase 2

Conditions

COVID-19

Treatments

Drug: Hydroxychloroquine
Drug: Azithromycin

Study type

Interventional

Funder types

Other

Identifiers

NCT04329832
1051355

Details and patient eligibility

About

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.

Enrollment

85 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

85 participants in 2 patient groups

Hydroxychloroquine
Experimental group
Treatment:
Drug: Hydroxychloroquine
Azithromycin
Active Comparator group
Treatment:
Drug: Azithromycin

Trial documents
2

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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