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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04329832
Recruitment Status : Recruiting
First Posted : April 1, 2020
Last Update Posted : April 9, 2020
Sponsor:
Collaborator:
University of Utah
Information provided by (Responsible Party):
Samuel Brown, Intermountain Health Care, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Hydroxychloroquine Drug: Azithromycin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19 (HAHPS): A Prospective Pragmatic Trial
Actual Study Start Date : March 30, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021


Arm Intervention/treatment
Experimental: Hydroxychloroquine 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).

Active Comparator: Azithromycin Drug: 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, the prior doses will count toward the 5-day total.




Primary Outcome Measures :
  1. COVID Ordinal Outcomes Scale at 14 days [ Time Frame: Assessed once on day 14 after enrollment (enrollment is day 0) ]
    Per https://www.who.int/blueprint/priority-diseases/key-action/COVID-19_Treatment_Trial_Design_Master_Protocol_synopsis_Final_18022020.pdf, 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 Outcome Measures :
  1. Hospital-free days at 28 days (number of days patient not in hospital) [ Time Frame: Admission (day 1) to 28 days after admission (day 28) ]
    Calculated as a worst-rank ordinal (death is counted as -1 days).

  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 a worst-rank ordinal (death is counted as -1 days).

  3. ICU-free days at 28 days (number of days patient not in an ICU) [ Time Frame: Admission (day 1) to 28 days after admission (day 28) ]
    Calculated as a worst-rank ordinal (death is counted as -1 days).

  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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Patients must be enrolled within 48 hours of hospital admission

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, or propafenone
  • Known history of long QT syndrome
  • Current known QTc>500 msec
  • Pregnant or nursing
  • Prisoner
  • Weight < 35kg
  • Severe liver disease
  • Seizure disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04329832


Contacts
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Contact: Valerie T Aston, MBA 8015074606 Valerie.Aston@imail.org
Contact: David P Tomer, MS 801-507-4694 David.Tomer@imail.org

Locations
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United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84107
Contact: Valerie T Aston, MD MS    801-507-4606    Valerie.Aston@imail.org   
Contact: Jake Krong    801-507-9333    Jake.Krong@imail.org   
Principal Investigator: Samuel M Brown, MD MS         
University of Utah Not yet recruiting
Salt Lake City, Utah, United States, 84112
Contact: Estelle Harris, MD         
Principal Investigator: Estelle Harris, MD         
Sponsors and Collaborators
Intermountain Health Care, Inc.
University of Utah
Investigators
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Principal Investigator: Samuel M Brown, MD MS Intermountain Health Care, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Samuel Brown, Director, Critical Care Research, Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT04329832    
Other Study ID Numbers: 1051355
First Posted: April 1, 2020    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samuel Brown, Intermountain Health Care, Inc.:
SARS-CoV-2
Hydroxychloroquine
Azithromycin
Additional relevant MeSH terms:
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Azithromycin
Hydroxychloroquine
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents