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 : June 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Hydroxychloroquine Drug: Azithromycin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
|Active Comparator: 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 (no more than 2 days), the prior doses will count toward the 5-day total.
- 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".
- 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).
- 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).
- 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).
- Time to a 1-point decrease in the WHO ordinal recovery score [ Time Frame: Admission (day 1) to 14 days after admission (day 14) ]
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
|Contact: Valerie T Aston, MBA||8015074606||Valerie.Aston@imail.org|
|Contact: David P Tomer, MS||801-507-4694||David.Tomer@imail.org|
|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||Recruiting|
|Salt Lake City, Utah, United States, 84112|
|Contact: Estelle Harris, MD|
|Principal Investigator: Estelle Harris, MD|
|Principal Investigator:||Samuel M Brown, MD MS||Intermountain Health Care, Inc.|