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Hydroxychloroquine versus Azithromycin for Hospitalized Patients with Suspected or Confirmed COVID-19 (HAHPS). Protocol for a Pragmatic, Open-Label, Active Comparator Trial
Author(s) -
Samuel M. Brown,
Ithan D. Peltan,
Brandon Webb,
Naresh Kumar,
Nathan Starr,
Colin K. Grissom,
Whitney R. Buckel,
Rajendu Srivastava,
Estelle S. Harris,
Lindsay Leither,
Stacy A. Johnson,
Robert Paine,
Tom Greene
Publication year - 2020
Publication title -
annals of the american thoracic society
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.035
H-Index - 114
eISSN - 2329-6933
pISSN - 2325-6621
DOI - 10.1513/annalsats.202004-309sd
Subject(s) - medicine , context (archaeology) , clinical trial , azithromycin , hydroxychloroquine , interim , interim analysis , randomized controlled trial , protocol (science) , intensive care medicine , family medicine , alternative medicine , covid-19 , disease , pathology , infectious disease (medical specialty) , history , paleontology , archaeology , microbiology and biotechnology , biology , antibiotics
Coronavirus disease (COVID-19) is a potentially fatal illness with no proven therapy beyond excellent supportive care. Treatments are urgently sought. Adaptations to traditional trial logistics and design to allow rapid implementation, evaluation of trials within a global trials context, flexible interim monitoring, and access outside traditional research hospitals (even in settings where formal placebos are unavailable) may be helpful. Thoughtful adaptations to traditional trial designs, especially within the global context of related studies, may also foster collaborative relationships among government, community, and the research enterprise. Here, we describe the protocol for a pragmatic, active comparator trial in as many as 300 patients comparing two current "off-label" treatments for COVID-19-hydroxychloroquine and azithromycin-in academic and nonacademic hospitals in Utah. We developed the trial in response to local pressures for widespread, indiscriminate off-label use of these medications. We used a hybrid Bayesian-frequentist design for interim monitoring to allow rapid, contextual assessment of the available evidence. We also developed an inference grid for interpreting the range of possible results from this trial within the context of parallel trials and prepared for a network meta-analysis of the resulting data. This trial was prospectively registered (ClinicalTrials.gov Identifier: NCT04329832) before enrollment of the first patient.Clinical trial registered with www.clinicaltrials.gov (NCT04329832).

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