• Wesley H Self, Matthew W Semler, Lindsay M Leither, Jonathan D Casey, Derek C Angus, Roy G Brower, Steven Y Chang, Sean P Collins, John C Eppensteiner, Michael R Filbin, D Clark Files, Kevin W Gibbs, Adit A Ginde, Michelle N Gong, Frank E Harrell, Douglas L Hayden, Catherine L Hough, Nicholas J Johnson, Akram Khan, Christopher J Lindsell, Michael A Matthay, Marc Moss, Pauline K Park, Todd W Rice, RobinsonBryce R HBRHDepartment of Surgery, University of Washington, Seattle., David A Schoenfeld, Nathan I Shapiro, Jay S Steingrub, Christine A Ulysse, Alexandra Weissman, Donald M Yealy, B Taylor Thompson, Samuel M Brown, National Heart, Lung, and Blood Institute PETAL Clinical Trials Network, Jay Steingrub, Howard Smithline, Bogdan Tiru, Mark Tidswell, Lori Kozikowski, Sherell Thornton-Thompson, Leslie De Souza, Peter Hou, Rebecca Baron, Anthony Massaro, Imoigele Aisiku, Lauren Fredenburgh, Raghu Seethala, Lily Johnsky, Richard Riker, David Seder, Teresa May, Michael Baumann, Ashley Eldridge, Christine Lord, Nathan Shapiro, Daniel Talmor, Thomas O’Mara, Charlotte Kirk, Kelly Harrison, Lisa Kurt, Margaret Schermerhorn, Valerie Banner-Goodspeed, Katherine Boyle, Nicole Dubosh, Michael Filbin, Kathryn Hibbert, Blair Parry, Kendall Lavin-Parsons, Natalie Pulido, Brendan Lilley, Carl Lodenstein, Justin Margolin, Kelsey Brait, Alan Jones, James Galbraith, Rebekah Peacock, Utsav Nandi, Taylor Wachs, Michael Matthay, Kathleen Liu, Kirsten Kangelaris, Ralph Wang, Carolyn Calfee, Kimberly Yee, Gregory Hendey, Steven Chang, George Lim, Nida Qadir, Andrea Tam, Rebecca Beutler, Joseph Levitt, Jenny Wilson, Angela Rogers, Rosemary Vojnik, Jonasel Roque, Timothy Albertson, James Chenoweth, Jason Adams, Skyler Pearson, Maya Juarez, Eyad Almasri, Mohamed Fayed, Alyssa Hughes, Shelly Hillard, Ryan Huebinger, Henry Wang, Elizabeth Vidales, Bela Patel, Adit Ginde, Amiran Baduashvili, Jeffrey McKeehan, Lani Finck, Carrie Higgins, Michelle Howell, Ivor Douglas, Jason Haukoos, Terra Hiller, Carolynn Lyle, Alicia Cupelo, Emily Caruso, Claudia Camacho, Stephanie Gravitz, James Finigan, Christine Griesmer, Pauline Park, Robert Hyzy, Kristine Nelson, Kelli McDonough, Norman Olbrich, Mark Williams, Raj Kapoor, Jean Nash, Meghan Willig, Henry Ford, Jayna Gardner-Gray, Mayur Ramesh, Montefiore Moses, Michelle Ng Gong, Michael Aboodi, Ayesha Asghar, Omowunmi Amosu, Madeline Torres, Savneet Kaur, Jen-Ting Chen, Aluko Hope, Brenda Lopez, Kathleen Rosales, Young YouJeeJ, Jarrod Mosier, Cameron Hypes, Bhupinder Natt, Bryan Borg, Elizabeth Salvagio Campbell, R Duncan Hite, Kristin Hudock, Autumn Cresie, Faysal Alhasan, Jose Gomez-Arroyo, Abhijit Duggal, Omar Mehkri, Andrei Hastings, Debasis Sahoo, Francois Abi Fadel, Susan Gole, Valerie Shaner, Allison Wimer, Yvonne Meli, Alexander King, Thomas Terndrup, Matthew Exline, Sonal Pannu, Emily Robart, Sarah Karow, Catherine Hough, Bryce Robinson, Nicholas Johnson, Daniel Henning, Monica Campo, Stephanie Gundel, Sakshi Seghal, Sarah Katsandres, Sarah Dean, Olivia Krol, Milad Jouzestani, Peter Huynh, Donald Yealy, Denise Scholl, Peter Adams, Bryan McVerry, David Huang, Derek Angus, Jordan Schooler, Steven Moore, Clark Files, Chadwick Miller, Kevin Gibbs, Mary LaRose, Lori Flores, Lauren Koehler, Caryn Morse, John Sanders, Caitlyn Langford, Kristen Nanney, Masiku MdalaGausi, Phyllis Yeboah, Peter Morris, Jamie Sturgill, Sherif Seif, Evan Cassity, Sanjay Dhar, Marjolein de Wit, Jessica Mason, Andrew Goodwin, Greg Hall, Abbey Grady, Amy Chamberlain, Samuel Brown, Joseph Bledsoe, Lindsay Leither, Ithan Peltan, Nathan Starr, Melissa Fergus, Valerie Aston, Quinn Montgomery, Rilee Smith, Mardee Merrill, Katie Brown, Brent Armbruster, Estelle Harris, Elizabeth Middleton, Robert Paine, Stacy Johnson, Macy Barrios, John Eppensteiner, Alexander Limkakeng, Lauren McGowan, Tedra Porter, Andrew Bouffler, J. Clancy Leahy, Bennet deBoisblanc, Matthew Lammi, Kyle Happel, Paula Lauto, Wesley Self, Jonathan Casey, Matthew Semler, Sean Collins, Frank Harrell, Christopher Lindsell, Todd Rice, William Stubblefield, Christopher Gray, Jakea Johnson, Megan Roth, Margaret Hays, Donna Torr, Arwa Zakaria, David Schoenfeld, Taylor Thompson, Douglas Hayden, Nancy Ringwood, Cathryn Oldmixon, Christine Ulysse, Richard Morse, Ariela Muzikansky, Laura Fitzgerald, Samuel Whitaker, Adrian Lagakos, Roy Brower, Lora Reineck, Neil Aggarwal, Karen Bienstock, Michelle Freemer, Myron Maclawiw, Gail Weinmann, Laurie Morrison, Mark Gillespie, Richard Kryscio, Daniel Brodie, Wojciech Zareba, Anne Rompalo, Michael Boeckh, Polly Parsons, Jason Christie, Jesse Hall, Nicholas Horton, Laurie Zoloth, Neal Dickert, and Deborah Diercks.
• Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.
• JAMA. 2020 Dec 1; 324 (21): 216521762165-2176.

ImportanceData on the efficacy of hydroxychloroquine for the treatment of coronavirus disease 2019 (COVID-19) are needed.ObjectiveTo determine whether hydroxychloroquine is an efficacious treatment for adults hospitalized with COVID-19.Design, Setting, And ParticipantsThis was a multicenter, blinded, placebo-controlled randomized trial conducted at 34 hospitals in the US. Adults hospitalized with respiratory symptoms from severe acute respiratory syndrome coronavirus 2 infection were enrolled between April 2 and June 19, 2020, with the last outcome assessment on July 17, 2020. The planned sample size was 510 patients, with interim analyses planned after every 102 patients were enrolled. The trial was stopped at the fourth interim analysis for futility with a sample size of 479 patients.InterventionsPatients were randomly assigned to hydroxychloroquine (400 mg twice daily for 2 doses, then 200 mg twice daily for 8 doses) (n = 242) or placebo (n = 237).Main Outcomes And MeasuresThe primary outcome was clinical status 14 days after randomization as assessed with a 7-category ordinal scale ranging from 1 (death) to 7 (discharged from the hospital and able to perform normal activities). The primary outcome was analyzed with a multivariable proportional odds model, with an adjusted odds ratio (aOR) greater than 1.0 indicating more favorable outcomes with hydroxychloroquine than placebo. The trial included 12 secondary outcomes, including 28-day mortality.ResultsAmong 479 patients who were randomized (median age, 57 years; 44.3% female; 37.2% Hispanic/Latinx; 23.4% Black; 20.1% in the intensive care unit; 46.8% receiving supplemental oxygen without positive pressure; 11.5% receiving noninvasive ventilation or nasal high-flow oxygen; and 6.7% receiving invasive mechanical ventilation or extracorporeal membrane oxygenation), 433 (90.4%) completed the primary outcome assessment at 14 days and the remainder had clinical status imputed. The median duration of symptoms prior to randomization was 5 days (interquartile range [IQR], 3 to 7 days). Clinical status on the ordinal outcome scale at 14 days did not significantly differ between the hydroxychloroquine and placebo groups (median [IQR] score, 6 [4-7] vs 6 [4-7]; aOR, 1.02 [95% CI, 0.73 to 1.42]). None of the 12 secondary outcomes were significantly different between groups. At 28 days after randomization, 25 of 241 patients (10.4%) in the hydroxychloroquine group and 25 of 236 (10.6%) in the placebo group had died (absolute difference, -0.2% [95% CI, -5.7% to 5.3%]; aOR, 1.07 [95% CI, 0.54 to 2.09]).Conclusions And RelevanceAmong adults hospitalized with respiratory illness from COVID-19, treatment with hydroxychloroquine, compared with placebo, did not significantly improve clinical status at day 14. These findings do not support the use of hydroxychloroquine for treatment of COVID-19 among hospitalized adults.Trial RegistrationClinicalTrials.gov: NCT04332991.

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