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1. Organization of Outpatient Care After COVID-19 Hospitalization

Author

Thomas S. Valley, Amanda Schutz, Ithan D. Peltan, Kelly C. Vranas, Kusum S. Mathews, Sarah E. Jolley, Jessica A. Palakshappa, Catherine L. Hough, Jay S. Steingrub, Mark A. Tidswell, Lori-Ann Kozikowski, Cynthia Kardos, Lesley DeSouza, Rebecca M. Baron, Mayra Pinilla-Vera, David M. Rubins, Antonio Arciniegas, Richard Riker, Christine Lord, Marie-Carmelle Elie, Daniel Talmor, Nathan Shapiro, Valerie Banner-Goodspeed, Kathryn A. Hibbert, Kelsey Brait, Natalie Pulido, Alan Jones, James Galbraith, Utsav Nandi, Rebekah Peacock, Jenna Davis, Matthew Prekker, Michael Puskarich, Seth Jones, Anne Roerhl, Audrey Hendrickson, Michael Matthay, Kirsten Kangelaris, Kathleen Liu, Kimberly Yee, Hanjing Zhuo, Gregory Hendey, Steven Chang, Nida Qadir, Andrea Tam, Rebecca Beutler, Trisha Agarwal, Joseph Levitt, Jennifer G. Wilson, Angela Rogers, Jonasel Roque, Rosemary Vojnik, Timothy E. Albertson, James A. Chenoweth, Jason Y. Adams, Brian M. Morrissey, Skyler J. Pearson, Eyad Almasri, Alyssa Hughes, Marc Moss, Adit Ginde, Jeffrey McKeehan, Lani Finck, Michelle Howell, Carrie Higgins, Jason Haukoos, Stephanie Gravitz, Carolynn Lyle, Ivor S. Douglas, Terra Hiller, Audrey Goold, James Finigan, Robert Hyzy, Pauline Park, Michael Sjoding, Stephen Kay, Kristine Nelson, Kelli McDonough, Namita Jayaprakash, Emanuel P. Rivers, Jennifer Swiderek, Jasreen Kaur Gill, Jacqueline Day, Robert Sherwin, James Wooden, Thomas Mazzoco, Michelle Ng Gong, Michael Aboodi, Ayesha Asghar, Omowunmi Amosu, Hiwet Tzehaie, Aluko A. Hope, Jen-Ting Chen, Rahul Nair, Brenda Lopez, Obiageli Offor, Jarrod M. Mosier, Cameron D. Hypes, Elizabeth Salvagio, Christian Bime, Elaine Cristan, Lynne D. Richardson, Neha Goel, Patrick Maher, Samuel Acquah, Donald Cardone, Gary Oldenburg, Andrew Dunn, Duncan Hite, Kristin Hudock, Jose Gomez Arroyo, Tammy Roads, Abhijit Duggal, Eduardo Mireles-Cabodevila, Bryce R.H. Robinson, Nicholas J. Johnson, Stephanie Gundel, Laura Evans, D. Shane O'Mahony, Julie A. Wallick, Isabel Pedraza, Akram Khan, Olivia Krol, Milad Karami Jouzestani, Kelly Vranas, Donald M. Yealy, Derek C. Angus, Alexandra Weissman, David T. Huang, Aimee Boeltz-Skrtich, Steven Moore, Derek Isenberg, D. Clark Files, Chadwick Miller, Kevin Gibbs, Lori Flores, Mary LaRose, Lauren Koehler, Leigha Landreth, Peter Morris, Evan Cassity, Jamie Sturgill, Kirby Mayer, Ashley Montgomery-Yates, Marjolein de Wit, Jessica Mason, Andrew Goodwin, Abigail Grady, Patterson Burch, Kyle B. Enfield, Jeffrey M. Sturek, Mary Marshall, Joseph R. Bledsoe, Samuel M. Brown, Colin K. Grissom, Brent Armbruster, Estelle Harris, John Eppensteiner, Bria Johnston Hall, Grace L. Hall, Lauren McGowan, Andrew Bouffler, Erica Walker, Samuel Francis, Tedra Porter, Bennett P. deBoisblanc, Matthew R. Lammi, David R. Janz, Paula Lauto, Connie Romaine, Marie Sandi, Todd W. Rice, Wesley H. Self, Nancy Ringwood, Alexander Nagrebetsky, Laura Fitzgerald, Roy G. Brower, Lora A. Reineck, Neil R. Aggarwal, and Karen Bienstock

Subjects
Hospitalization, Pulmonary and Respiratory Medicine, Ambulatory Care, COVID-19, Humans, Cardiology and Cardiovascular Medicine, Critical Care and Intensive Care Medicine
Published
2022
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2. Effect of Hydroxychloroquine on Clinical Status at 14 Days in Hospitalized Patients With COVID-19: A Randomized Clinical Trial

Author

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, Bryce R H, Robinson, David A, Schoenfeld, Nathan I, Shapiro, Jay S, Steingrub, Christine A, Ulysse, Alexandra, Weissman, Donald M, Yealy, B Taylor, Thompson, Samuel M, Brown, 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, Jee, Young You, 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

Subjects
Adult, Male, medicine.medical_specialty, Randomization, Science, Pneumonia, Viral, Placebo, 01 natural sciences, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Interquartile range, Internal medicine, medicine, Humans, Treatment Failure, 030212 general & internal medicine, 0101 mathematics, Pandemics, Aged, Original Investigation, business.industry, SARS-CoV-2, 010102 general mathematics, Politics, Hydroxychloroquine, General Medicine, Odds ratio, Middle Aged, Interim analysis, Intensive care unit, COVID-19 Drug Treatment, Female, business, medicine.drug
Abstract

Importance Data on the efficacy of hydroxychloroquine for the treatment of coronavirus disease 2019 (COVID-19) are needed. Objective To determine whether hydroxychloroquine is an efficacious treatment for adults hospitalized with COVID-19. Design, Setting, and Participants This 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. Interventions Patients 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 Measures The 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. Results Among 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 Relevance Among 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 Registration ClinicalTrials.gov:NCT04332991

Published
2020

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