Abstract: Submitted to the New England Journal of Medicine Please review the Supplemental Files folder to review documents not compiled in the PDF. Co Clinical Outcomes of Hydroxychloroquine in Hospitalized Patients with COVID-19: A Quasi-Randomized Comparative Study nf Journal: New England Journal of Medicine Manuscript ID 20-08882 ide Article Type: Rapid Review Date Submitted by the 04-Apr-2020 Author: ial nt 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, w vie Re or :F 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. Page 1 of 13 w vie Re or :F ial nt ide nf Co 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 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 Co 3Department of Ophthalmology, Henry Ford Hospital System, Detroit, Michigan, USA nf Corresponding Author: Dr. Xihui Lin Address: 4717 St. Antoine, Detroit, MI, 48201, USA ide Telephone Number: 313-577-8900 Email: xihui.lin@wayne.edu ial nt Conflict of Interest: None of the authors have any conflicts of interest..