Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19
HAHPS
1 other identifier
interventional
85
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 covid19
Started Mar 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2020
CompletedStudy Start
First participant enrolled
March 30, 2020
CompletedFirst Posted
Study publicly available on registry
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedResults Posted
Study results publicly available
April 20, 2022
CompletedApril 20, 2022
April 1, 2022
3 months
March 30, 2020
March 14, 2022
April 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Hospital-free Days at 28 Days
Admission (day 1) to 28 days after admission (day 28)
Ventilator-free Days at 28 Days (Number of Days Patient Not on a Ventilator)
Admission (day 1) to 28 days after admission (day 28)
ICU-free Days at 28 Days
Admission (day 1) to 28 days after admission (day 28)
Time to a 1-point Decrease in the WHO Ordinal Recovery Score
Admission (day 1) to 14 days after admission (day 14)
Study Arms (2)
Hydroxychloroquine
EXPERIMENTALAzithromycin
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Intermountain Health Care, Inc.lead
- University of Utahcollaborator
Study Sites (2)
Intermountain Medical Center
Murray, Utah, 84107, United States
University of Utah
Salt Lake City, Utah, 84112, United States
Related Publications (4)
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
BACKGROUNDKoric 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.
PMID: 35561317DERIVEDBrown 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 versus Azithromycin for Hospitalized Patients with COVID-19. Results of a Randomized, Active Comparator Trial. Ann Am Thorac Soc. 2021 Apr;18(4):590-597. doi: 10.1513/AnnalsATS.202008-940OC.
PMID: 33166179DERIVEDBrown 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.
PMID: 32425051DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Naresh Kumar
- Organization
- Intermountain Healthcare
Study Officials
- PRINCIPAL INVESTIGATOR
Samuel M Brown, MD MS
Intermountain Health Care, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Critical Care Research
Study Record Dates
First Submitted
March 30, 2020
First Posted
April 1, 2020
Study Start
March 30, 2020
Primary Completion
July 1, 2020
Study Completion
January 1, 2021
Last Updated
April 20, 2022
Results First Posted
April 20, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share
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.