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Completed

NCT Number: NCT04329832

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Intermountain Medical Center, Murray, Utah, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydroxychloroquine

Drug

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

Drug

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.

Primary outcomes

  1. COVID Ordinal Outcomes Scale at 14 Days

    Time frame: Assessed once on day 14 after enrollment (enrollment is day 0)

    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".

Secondary outcomes

  1. Hospital-free Days at 28 Days

    Time frame: Admission (day 1) to 28 days after admission (day 28)

    Calculated as number of days patient not in hospital

  2. Ventilator-free Days at 28 Days (Number of Days Patient Not on a Ventilator)

    Time frame: Admission (day 1) to 28 days after admission (day 28)

    Calculated as number of days that patient is not on a ventilator up to day 28 days after admission

  3. ICU-free Days at 28 Days

    Time frame: Admission (day 1) to 28 days after admission (day 28)

    Calculated as number of days patient not in an ICU

  4. Time to a 1-point Decrease in the WHO Ordinal Recovery Score

    Time frame: Admission (day 1) to 14 days after admission (day 14)

    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".

Sponsors and collaborators

Lead sponsor

Intermountain Health Care, Inc.

Other

Collaborators

  • University of Utah

Registry information

Official study title

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

Acronym: HAHPS

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Apr 1, 2020
Registry last updated
Apr 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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