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

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hydroxychloroquine
Azithromycin
Sponsored by
Intermountain Health Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring SARS-CoV-2, Hydroxychloroquine, Azithromycin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Intermountain Medical Center
  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hydroxychloroquine

Azithromycin

Arm Description

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

Hospital-free Days at 28 Days
Calculated as number of days patient not in hospital
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
ICU-free Days at 28 Days
Calculated as number of days patient not in an ICU
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".

Full Information

First Posted
March 30, 2020
Last Updated
April 18, 2022
Sponsor
Intermountain Health Care, Inc.
Collaborators
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT04329832
Brief Title
Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19
Acronym
HAHPS
Official Title
Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19 (HAHPS): A Prospective Pragmatic Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 30, 2020 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
January 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Intermountain Health Care, Inc.
Collaborators
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
SARS-CoV-2, Hydroxychloroquine, Azithromycin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydroxychloroquine
Arm Type
Experimental
Arm Title
Azithromycin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
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 Outcome Measure Information:
Title
COVID Ordinal Outcomes Scale at 14 Days
Description
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".
Time Frame
Assessed once on day 14 after enrollment (enrollment is day 0)
Secondary Outcome Measure Information:
Title
Hospital-free Days at 28 Days
Description
Calculated as number of days patient not in hospital
Time Frame
Admission (day 1) to 28 days after admission (day 28)
Title
Ventilator-free Days at 28 Days (Number of Days Patient Not on a Ventilator)
Description
Calculated as number of days that patient is not on a ventilator up to day 28 days after admission
Time Frame
Admission (day 1) to 28 days after admission (day 28)
Title
ICU-free Days at 28 Days
Description
Calculated as number of days patient not in an ICU
Time Frame
Admission (day 1) to 28 days after admission (day 28)
Title
Time to a 1-point Decrease in the WHO Ordinal Recovery Score
Description
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".
Time Frame
Admission (day 1) to 14 days after admission (day 14)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel M Brown, MD MS
Organizational Affiliation
Intermountain Health Care, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
Citation
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
Results Reference
background
PubMed Identifier
35561317
Citation
Koric A, Chang CP, Mark B, Rowe K, Snyder J, Dodson M, Deshmukh VG, Newman MG, Fraser AM, Smith KR, Date AP, Gren LH, Porucznik CA, Haaland BA, Henry NL, Hashibe M. Cardiovascular disease risk in long-term breast cancer survivors: A population-based cohort study. Cancer. 2022 Jul 15;128(14):2826-2835. doi: 10.1002/cncr.34224. Epub 2022 May 13.
Results Reference
derived
PubMed Identifier
33166179
Citation
Brown SM, Peltan I, Kumar N, Leither L, Webb BJ, Starr N, Grissom CK, Buckel WR, Srivastava R, Butler AM, Groat D, Haaland B, Ying J, Harris E, Johnson S, Paine R 3rd, Greene T. Hydroxychloroquine vs. Azithromycin for Hospitalized Patients with COVID-19 (HAHPS): Results of a Randomized, Active Comparator Trial. Ann Am Thorac Soc. 2020 Nov 9;18(4):590-7. doi: 10.1513/AnnalsATS.202008-940OC. Online ahead of print.
Results Reference
derived
PubMed Identifier
32425051
Citation
Brown SM, Peltan ID, Webb B, Kumar N, Starr N, Grissom C, Buckel WR, Srivastava R, Harris ES, Leither LM, Johnson SA, Paine R 3rd, Greene T. Hydroxychloroquine versus Azithromycin for Hospitalized Patients with Suspected or Confirmed COVID-19 (HAHPS). Protocol for a Pragmatic, Open-Label, Active Comparator Trial. Ann Am Thorac Soc. 2020 Aug;17(8):1008-1015. doi: 10.1513/AnnalsATS.202004-309SD.
Results Reference
derived
Links:
URL
https://www.who.int/publications/i/item/covid-19-therapeutic-trial-synopsis
Description
Source for WHO COVID Ordinal Outcomes Scale

Learn more about this trial

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

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