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High-dose Hydroxychloroquine for Mild COVID-19: One Center’s Clinical Experience and Investigational Challenges
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  • Iazsmin Bauer Ventura,
  • Brian Labadie,
  • Patrick Onkka,
  • Pankti Reid,
  • Moira McNulty,
  • Cuoghi Edens,
  • David Beiser,
  • Mark J Ratain,
  • Reem Jan
Iazsmin Bauer Ventura
University of Chicago
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Brian Labadie
University of Chicago
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Patrick Onkka
Northwestern Medicine
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Pankti Reid
University of Chicago
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Moira McNulty
University of Chicago
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Cuoghi Edens
University of Chicago
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David Beiser
University of Chicago
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Mark J Ratain
University of Chicago
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Reem Jan
University of Chicago
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Abstract

Aims: The recently described SARS-CoV-2 has led to a pandemia which has severe consequences for the global community. Hydroxychloroquine has been repurposed for the treatment of COVID-19 but conflicting information on its efficacy and safety has since emerged. Our group designed a trial on the use of high-dose hydroxychloroquine in a high-risk ambulatory population with mild COVID-19 (NCT04351620) and summarizes herein the clinical data of hydroxychloroquine in COVID-19. Methods: Single-arm and single-center study evaluating the tolerability of high-dose hydroxychloroquine, 600 mg twice daily for 5 days, in patients with mild COVID-19 and risk factors for clinical decompensation and hospitalization. Secondary objectives included maintenance of ambulatory status, defervescence, and symptom relief. Results: Over a six-week period, 59 patients met eligibility criteria out of 314 contacted (18.7%). Out of these 59 potentially eligible patients, 44 (74.5%) patients declined to be screened further due to concerns about its risks and unproven efficacy, referencing media accounts and politization of the medication. Out of the 9 patients consented, 2 did not complete the therapy plan, 1 due to headaches, 1 did not follow up. Two of the 7 patients who completed the study continued to have fevers, one was admitted for pneumonia. Study was terminated early due to recruitment difficulties. Conclusions: The trial met pre-defined primary outcome of tolerability, but sample size was too small to allow further interpretation. The political climate and media coverage might have negatively impacted patient recruitment, which has ultimately led to its early interruption.