Clinical trial NCT04329832: Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19
Official title: Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19 (HAHPS): A Prospective Pragmatic Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: SARS-CoV-2
Hydroxychloroquine
Azithromycin
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: University of Utah
First posted: 2020-04-01
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: COVID Ordinal Outcomes Scale at 14 Days
timeFrame: Assessed once on day 14 after enrollment (enrollment is day 0)
Secondary outcomes:
measure: Hospital-free Days at 28 Days
timeFrame: Admission (day 1) to 28 days after admission (day 28)
measure: Ventilator-free Days at 28 Days (Number of Days Patient Not on a Ventilator)
timeFrame: Admission (day 1) to 28 days after admission (day 28)
measure: ICU-free Days at 28 Days
timeFrame: Admission (day 1) to 28 days after admission (day 28)
measure: Time to a 1-point Decrease in the WHO Ordinal Recovery Score
timeFrame: Admission (day 1) to 14 days after admission (day 14)
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Samuel M Brown, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
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
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.
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.
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.