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Misguided Use of Hydroxychloroquine for COVID-19The Infusion of Politics Into Science

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To identify the key insights or developments described in this article
1 Credit CME

This issue of JAMA contains yet another study, and certainly among the best published to date, demonstrating the lack of efficacy of hydroxychloroquine as a treatment of coronavirus disease 2019 (COVID-19).1 This study, from the National Heart, Lung, and Blood Institute PETAL Clinical Trials Network, focused on hospitalized patients with moderate to severe disease. In this well-conducted, appropriately powered clinical trial, the authors randomized 479 patients to receive hydroxychloroquine (400 mg twice daily for 2 doses, then 200 mg twice daily for 8 doses) (n = 242) or placebo (n = 237). The trial was stopped early at the fourth interim analysis for futility. For the primary outcome, clinical status at 14 days measured on a 7-category ordinal scale, there was no significant difference between the hydroxychloroquine and placebo groups (median [interquartile range {IQR}] score, 6 [4-7] vs 6 [4-7]; adjusted odds ratio, 1.02 [95% CI, 0.73-1.42]). None of the 12 secondary outcomes were significantly different between groups, including mortality at 28 days: 10.4% in the hydroxychloroquine group vs 10.6% in the placebo group (absolute difference, −0.2% [95% CI, −5.7% to 5.3%]; adjusted odds ratio, 1.07 [95% CI, 0.54 to 2.09]).1 Thus, the results conclusively show no benefit of hydroxychloroquine over placebo.

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Article Information

Corresponding Author: Michael S. Saag, MD, Department of Medicine, School of Medicine, University of Alabama at Birmingham, 845 19th St S, BBRB 256, Birmingham, AL 35294-2170 (msaag@uabmc.edu).

Published Online: November 9, 2020. doi:10.1001/jama.2020.22389

Conflict of Interest Disclosures: Dr Saag reported grants paid to his institution from ViiV Healthcare and Gilead Sciences.

References
1.
Self  WH , Semler  MW , Leither  LM ,  et al; National Heart, Lung, and Blood Institute PETAL Clinical Trials Network.  Effect of hydroxychloroquine on clinical status at 14 days in hospitalized patients with COVID-19: a randomized clinical trial.   JAMA. Published online November 9, 2020. doi:10.1001/jama.2020.22240Google Scholar
2.
Casey  JD , Johnson  NJ , Semler  MW ,  et al.  Rationale and design of ORCHID: a randomized placebo-controlled clinical trial of hydroxychloroquine for adults hospitalized with COVID-19.   Ann Am Thorac Soc. 2020;17(9):1144-1153. doi:10.1513/AnnalsATS.202005-478SD PubMedGoogle ScholarCrossref
3.
Horby  P , Mafham  M , Linsell  L ,  et al; RECOVERY Collaborative Group.  Effect of hydroxychloroquine in hospitalized patients with COVID-19.   N Engl J Med. 2020. doi:10.1056/NEJMoa2022926PubMedGoogle Scholar
4.
Cavalcanti  AB , Zampieri  FG , Rosa  RG ,  et al; Coalition Covid-19 Brazil I Investigators.  Hydroxychloroquine with or without azithromycin in mild-to-moderate COVID-19.   N Engl J Med. 2020. doi:10.1056/NEJMoa2019014 PubMedGoogle Scholar
5.
Boulware  DR , Pullen  MF , Bangdiwala  AS ,  et al.  A randomized trial of hydroxychloroquine as postexposure prophylaxis for COVID-19.   N Engl J Med. 2020;383(6):517-525. doi:10.1056/NEJMoa2016638 PubMedGoogle ScholarCrossref
6.
Gautret  P , Lagier  J-C , Parola  P ,  et al.  Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial.   Int J Antimicrob Agents. Published online March 20, 2020. doi:10.1016/j.ijantimicag.2020.105949. PubMedGoogle Scholar
7.
Crowley  M , Thomas  K , Haberman  M . Ignoring expert opinion, Trump again promotes hydroxychloroquine. New York Times. Published April 5, 2020. Accessed November 2, 2020. https://www.nytimes.com/2020/04/05/us/politics/trump-hydroxychloroquine-coronavirus.html
8.
US Food and Drug Administration. Memorandum explaining basis for revocation of emergency use authorization for emergency use of chloroquine phosphate and hydroxychloroquine sulfate. June 15, 2020. Accessed November 2, 2020. https://www.fda.gov/media/138945/download
9.
Cohen J. Update: here’s what is known about Trump’s COVID-19 treatment. Published October 5, 2020. Accessed November 2, 2020. https://www.sciencemag.org/news/2020/10/heres-what-known-about-president-donald-trump-s-covid-19-treatment
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