Small retrospective study with 63 patients (32 treated with HCQ), showing no effectiveness, however the baseline state of each arm significantly differs.This preprint was submitted to NEJM but has not been published several months later.
This study is excluded in the after exclusion results of meta
analysis:
excessive unadjusted differences between groups.
Abstract: Submitted to the New England Journal of Medicine
Please review the Supplemental Files folder to review documents not compiled in the PDF.
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Clinical Outcomes of Hydroxychloroquine in Hospitalized
Patients with COVID-19: A Quasi-Randomized Comparative
Study
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Journal: New England Journal of Medicine
Manuscript ID 20-08882
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Article Type: Rapid Review
Date Submitted by the
04-Apr-2020
Author:
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Complete List of Authors: Barbosa, Joshua; Wayne State University School of Medicine; Sinai
Grace Hospital
Kaitis, Daniel; Henry Ford Hospital
Freedman, Ryan; Wayne State University School of Medicine
Le, Kim; Henry Ford Hospital
Lin, Xihui; Wayne State University School of Medicine,
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Background: Off-label use of hydroxychloroquine in the SARS-CoV-2
positive population has become widespread with only empirical evidence
on its efficacy. This study addresses the efficacy of hydroxychloroquine
on serological and supportive care measures in a hospitalized population.
Methods: Consecutive adult subjects admitted for viral pneumonia
secondary to SARS-CoV-2 (by polymerase chain reaction) during the last
two weeks of March, 2020 were included. Those that were started on
hydroxychloroquine and supportive care were compared to supportive
care alone. The primary end points were effect of hydroxychloroquine
usage on the need to escalate respiratory support, change in lymphocyte
count, and change in neutrophil-to-lymphocyte ratio.
Results: A total of 63 patients were included with 32 in the
hydroxychloroquine arm. Hydroxychloroquine administration was
Abstract:
associated with a need for escalation of respiratory support level
compared to those that did not receive hydroxychloroquine at 5 days
(p=0.013). The same findings were observed in a baseline-matched
subgroup analysis. Absolute lymphocyte change in the
hydroxychloroquine group was no different than supportive care alone
(p=0.413). Hydroxychloroquine use trended towards worsening
neutrophil-to-lymphocyte ratio compared to supportive care alone
(+9.59 vs +1.58, p=0.51) as well as a higher risk for intubation
(p=0.051).
Conclusion: Hydroxychloroquine administration to the hospitalized SARSCoV-2 positive population was associated with an increased need for
escalation of respiratory support. There were no benefits of
hydroxychloroquine on mortality, lymphopenia, or neutrophil-tolymphocyte ratio improvement.
Confidential: Destroy when review is complete.
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Submitted to the New England Journal of Medicine
Confidential: Destroy when review is complete.
Submitted to the New England Journal of Medicine
Clinical Outcomes of Hydroxychloroquine in Hospitalized Patients with COVID-19: A QuasiRandomized Comparative Study
Joshua Barbosa, MD1,2; Daniel Kaitis, MD3; Ryan Freedman, MD1; Kim Le, MD3; Xihui Lin, MD1
1Ophthalmology,
2Sinai
Kresge Eye Institute & Wayne State University Detroit, Michigan, USA
Grace Hospital, Detroit, Michigan, USA
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3Department
of Ophthalmology, Henry Ford Hospital System, Detroit, Michigan, USA
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Corresponding Author: Dr. Xihui Lin
Address: 4717 St. Antoine, Detroit, MI, 48201, USA
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Telephone Number: 313-577-8900
Email: xihui.lin@wayne.edu
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Conflict of Interest: None of the authors have any conflicts of interest..
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