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  • Examination of patient characteristics and hydroxychloroquine use based on the US Food and Drug Administration’s recommendation: a cross-sectional analysis in New York

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Global health
Original research
Examination of patient characteristics and hydroxychloroquine use based on the US Food and Drug Administration’s recommendation: a cross-sectional analysis in New York
  1. Eun Ji Kim1,2,
  2. Kevin Coppa3,
  3. Jamie S Hirsch1,2,3,
  4. Sara Abrahams1,
  5. Jennifer Johnson2,
  6. Martin Lesser1,2,4,
  7. Karina W Davidson1,2,
  8. Joseph Conigliaro1,2
  9. and the Northwell Health COVID-19 Research Consortium
    1. 1Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health, Hempstead, New York, USA
    2. 2Institute of Health Innovations and Outcomes Research, Feinstein Institutes for Medical Research, Northwell Health, Manhasset, New York, USA
    3. 3Department of Information Services, Northwell Health, New Hyde Park, New York, USA
    4. 4Biostatistics Unit, Feinstein Institutes for Medical Research, Northwell Health, Manhasset, New York, USA
    1. Correspondence to Dr Joseph Conigliaro; jconigliaro{at}northwell.edu

    Abstract

    Objective To describe the pattern of hydroxychloroquine use and examine the association between hydroxychloroquine use and clinical outcomes arising from changes in the US Food and Drug Administration (FDA)’s recommendation during the coronavirus disease 2019 (COVID-19) pandemic.

    Design A retrospective cross-sectional analysis.

    Setting and participants We included hospitalised adult patients at Northwell Health hospitals with confirmed COVID-19 infections between 1 March 2020 and 11 May 2020. We categorised changes in the FDA’s recommendation as pre-FDA approval (1 March 2020–27 March 2020), FDA approval (28 March 2020–23 April 2020), and FDA warning (24 April 2020–11 May 2020). The hydroxychloroquine-treated group received at least one dose within 48 hours of hospital admission.

    Primary outcome A composite of intubation and inpatient death.

    Results The percentages of patients who were treated with hydroxychloroquine were 192/2202 (8.7%) pre-FDA approval, 2902/6741 (43.0%) FDA approval, and 176/1066 (16.5%) FDA warning period (p<0.001). Using propensity score matching, there was a higher rate of the composite outcome among patients treated with hydroxychloroquine (49/192, 25.5%) compared with no hydroxychloroquine (66/384, 17.2%) in the pre-FDA approval period (p=0.03) but not in the FDA approval period (25.5% vs 22.6%, p=0.08) or the FDA warning (21.0% vs 15.1%, p=0.11) periods. Coincidently, there was an increase in number of patients with COVID-19 and disease severity during the FDA approval period (24.1% during FDA approval vs 21.4% during pre-FDA approval period had the composite outcome). Hydroxychloroquine use was associated with increased odds of the composite outcome during the pre-FDA approval period (OR=1.65 (95% CI 1.09 to 2.51)) but not during the FDA approval (OR=1.17 (95% CI 0.99 to 1.39)) and FDA warning (OR=1.50 (95% CI 0.94 to 2.39)) periods.

    Conclusions Hydroxychloroquine use was associated with adverse clinical outcomes only during the pre-FDA approval period but not during the FDA approval and warning periods, even after adjusting for concurrent changes in the percentage of patients with COVID-19 treated with hydroxychloroquine and the number (and disease severity) of hospitalised patients with COVID-19 infections.

    • COVID-19
    • public health
    • epidemiology
    http://creativecommons.org/licenses/by-nc/4.0/

    This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

    https://doi.org/10.1136/bmjopen-2020-042965

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      Footnotes

      • Collaborators The Northwell Health COVID-19 Research Consortium: Stuart L. Cohen, MD (Institute of Health Innovations and Outcome Research, Feinstein Institutes for Medical Research, Northwell Health, Manhasset, New York; Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health, Hempstead, New York); Charlotte Kvasnovsky, MD, PhD, MPH (Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health, Hempstead, New York); Stephen C. Machnicki, MD, FCCP (Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health, Hempstead, New York); Alex Makhnevich, MD (Institute of Health Innovations and Outcome Research, Feinstein Institutes for Medical Research, Northwell Health, Manhasset, New York; Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health, Hempstead, New York); Prashant Malhotra, MD (Institute of Health Innovations and Outcome Research, Feinstein Institutes for Medical Research, Northwell Health, Manhasset, New York; Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health, Hempstead, New York); Lyndonna Marrast, MD, MPH (Institute of Health Innovations and Outcome Research, Feinstein Institutes for Medical Research, Northwell Health, Manhasset, New York; Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health, Hempstead, New York); Ramanak Mitra, MD (Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health, Hempstead, New York); Ernesto P. Molmenti, MD (Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health, Hempstead, New York); Sonali Narain, MBBS, MPH (Institute of Health Innovations and Outcome Research, Feinstein Institutes for Medical Research, Northwell Health, Manhasset, New York; Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health, Hempstead, New York); M. Wasif Saif, MD, MBBS (Institute of Health Innovations and Outcome Research, Feinstein Institutes for Medical Research, Northwell Health, Manhasset, New York; Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health, Hempstead, New York); Sanjaya Satapathy, MD (Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health, Hempstead, New York); Shalin Shah, MD (Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health, Hempstead, New York).

      • Contributors Concept and design: EJK, KC, JSH, KWD, ML, JC. Acquisition: KC, JSH. Drafting of the manuscript: EJK, KC, SA, JJ. Critical revision of the manuscript for important intellectual content: all authors. Statistical analysis: KC, ML. Obtained funding: KWD. Administrative, technical or material support: KWD, JC. Supervision: ML, KWD, JC.

      • Funding This work was supported by grants R24AG064191 from the National Institute on Aging of the National Institutes of Health and R01LM012836 from the National Library of Medicine of the National Institutes of Health.

      • Competing interests None declared.

      • Patient and public involvement Patients and/or the public were not involved in the design, conduct, reporting, or dissemination plans of this research.

      • Patient consent for publication Not required.

      • Ethics approval The Institutional Review Board for the Feinstein Institutes for Medical Research at Northwell Health approved this case series as minimal-risk research using data collected for routine clinical practice and waived the requirement for informed consent.

      • Provenance and peer review Not commissioned; externally peer reviewed.

      • Data availability statement Data are available on reasonable request. The data that support the findings of this study are available on request from COVID19@northwell.edu. The data are not publicly available due to restrictions as they could compromise the privacy of research participants.