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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. Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO):a randomised controlled trial

Author

Wesley H. Self, Uriel Sandkovsky, Cavan S. Reilly, David M. Vock, Robert L. Gottlieb, Michael Mack, Kevin Golden, Emma Dishner, Andrew Vekstein, Emily R. Ko, Tatyana Der, John Franzone, Eyad Almasri, Mohamed Fayed, Michael R. Filbin, Kathryn A. Hibbert, Todd W. Rice, Jonathan D. Casey, J. Awori Hayanga, Vinay Badhwar, Bradley G. Leshnower, Milad Sharifpour, Kirk U. Knowlton, Ithan D. Peltan, Elizieta Bakowska, Justyna Kowalska, Michael E. Bowdish, Jeffrey M. Sturek, Angela J. Rogers, D. Clark Files, Jarrod M. Mosier, Michelle N. Gong, David J. Douin, R. Duncan Hite, Barbara W. Trautner, Mamta K. Jain, Edward M. Gardner, Akram Khan, Jens-Ulrik Jensen, Michael A. Matthay, Adit A. Ginde, Samuel M. Brown, Elizabeth S. Higgs, Sarah Pett, Amy C. Weintrob, Christina C. Chang, Daniel D. Murrary, Huldrych F. Günthard, Ellen Moquete, Greg Grandits, Nicole Engen, Birgit Grund, Shweta Sharma, Huyen Cao, Rajesh Gupta, Suzette Osei, David Margolis, Qing Zhu, Mark N. Polizzotto, Abdel G. Babiker, Victoria J. Davey, Virginia Kan, B. Taylor Thompson, Annetine C. Gelijns, James D. Neaton, H. Clifford Lane, Jens D. Jundgren, John Tierney, Kevin Barrett, Betsey R. Herpin, Mary C. Smolskis, Susan E. Voge, Laura A. McNay, Kelly Cahill, Page Crew, Matthew Kirchoff, Ratna Sardana, Sharon Segal Raim, Joseph Chiu, Lisa Hensley, Josua Lorenzo, Rebecca Mock, Katy Shaw-Saliba, Judith Zuckerman, Stacey J. Adam, Judy Currier, Sarah Read, Eric Hughes, Laura Amos, Amy Carlsen, Anita Carter, Bionca Davis, Eileen Denning, Alain DuChene, Merrie Harrison, Payton Kaiser, Joseph Koopmeiners, Sue Meger, Thomas Murray, Kien Quan, Siu Fun Quan, Greg Thompson, Jamie Walski, Deborah Wentworth, Alan J. Moskowitz, Emilia Bagiella, Karen O'Sullivan, Mary E. Marks, Evan Accardi, Emily Kinzel, Gabriela Bedoya, Lopa Gupta, Jessica R. Overbey, Maria L. Padillia, Milerva Santos, Marc A. Gillinov, Marissa A. Miller, Wendy C. Taddei-Peters, Kathleen Fenton, Mezgebe Berhe, Clinton Haley, Christopher Bettacchi, Erin Duhaime, Madison Ryan, Sarah Burris, Felecia Jones, Samantha Villa, Samantha Want, Raven Robert, Tanquinisha Coleman, Laura Clariday, Rebecca Baker, Marian Hurutado-Rodriguez, Nazia Iram, Michelle Fresnedo, Allyson Davis, Kiara Leonard, Noelia Ramierez, Jon Thammavong, Krizia Duque, Emma Turner, Tammy Fisher, Dianna Robinson, Desirae Ransom, Erica Lusk, Aaron Killian, Adriana Palacious, Edilia Solis, Janet Jerrow, Matthew Watts, Heather Whitacre, Elizabeth Cothran, Peter K. Smith, Christina E. Barkauskas, Grace R. Dreyer, Marie Witte, Nilima Mosaly, Ahmad Mourad, Thomas L. Holland, Kathleen Lane, Andrew Bouffler, Lauren M. McGowan, Marry Motta, Gregory Tipton, Ben Stallings, Gennifer Stout, Beth McLendon-Arvik, Beth A. Hollister, Dana M. Giangiacomo, Sunil Sharma, Brian Pappers, Paul McCarthy, Troy Krupica, Arif Sarwari, Rebecca Reece, Lisa Fornaresio, Chad Glaze, Raquel Evans, Katarina Preamble, Lisa Giblin Sutton, Sabrina Buterbaugh, Elizabeth Berry Bartolo, Roger Williams, Robin Bunner, William Bender, Jeffrey Miller, Kim T. Baio, Mary K. McBride, Michele Fielding, Sonya Mathewson, Kristina Porte, Missy Maton, Chari Ponder, Elizabeth Haley, Christine Spainhour, Susan Rogers, Derrick Tyler, Noah Wald-Dickler, Douglass Hutcheon, Amytis Towfighi, May M. Lee, Meghan R. Lewis, Brad Spellberg, Linda Sher, Aniket Sharma, Anna P. Olds, Chris Justino, Edward Lozano, Chris Romero, Janet Leong, Valentina Rodina, Tammie Possemato, Jose Escobar, Charlene Chiu, Kevin Weissman, Andrew Barros, Kyle B. Enfield, Alexandra Kadl, China J. Green, Rachel M. Simon, Ashley Fox, Kara Thornton, Patrick E. Parrino, Stephen Spindel, Aditya Bansal, Katherine Baumgarten, Jonathan Hand, Derek Vonderhaar, Bobby Nossaman, Sylvia Laudun, DeAnna Ames, Shane Broussard, Nilmo Hernandez, Geralyn Isaac, Huan Dinh, Yiling Zheng, Sonny Tran, Hunter McDaniel, Nicolle Crovetto, Leslie Miller, Beth Schelle, Sherry McLean, Howard R. Rothbaum, Michael S. Alvarez, Shivam P. Kalan, Heather H. Germann, Jennifer Hendershot, Karen Maroney, Karen Herring, Sharri Cook, Pam Paul, Ronson J. Madathil, Joseph Rabin, Andrea Levine, Kapil Saharia, Ali Tabatabai, Christine Lau, James S. Gammie, Maya-Loren Peguero, Kimberley McKernan, Matthew Audette, Emily Fleischmann, Freshta Akbari, Maia Lee, Myounghee Lee, Andrew Chi, Hanna Salehi, Alan Pariser, Phuong Tran Nguyen, Jessica Moore, Adrienne Gee, Shelika Vincent, Richard A. Zuckerman, Alexander Iribarne, Sara Metzler, Samantha Shipman, Taylor Caccia, Haley Johnson, Crystallee Newton, Doug Parr, Vicente Rodriguez, Gordon Bokhart, Sharon M. Eichman, Crystal North, Cathryn Oldmixon, Nancy Ringwood, Laura Fitzgerald, Haley D. Morin, Ariela Muzikansky, Richard Morse, Roy G. Brower, Lora A. Reineck, Neil R. Aggarwal, Karen Bienstock, Peter Hou, Jay Steingrub, Mark A. Tidswell, Lori-Ann Kozikowski, Cynthia Kardos, Leslie DeSouza, Sherell Thornton-Thompson, Daniel Talmor, Nathan Shapiro, Valerie Banner-Goodspeed, Katherine L. Boyle, Sharon Hayes, Alan E. Jones, James Galbraith, Utsav Nandi, Rebekah K. Peacock, Blair Alden Parry, Justin D. Margolin, Kelsey Brait, Caroline Beakes, Kirsten N. Kangelaris, Kimberly J. Yee, Kimia Ashktorab, Alejandra E. Jauregui, Hanjing Zhuo, Gregory Hendey, Kinsley A. Hubel, Alyssa R. Hughes, Rebekah L. Garcia, Jennifer G. Wilson, Rosemary Vojnik, Jonasel Roque, Cynthia Perez, George W. Lim, Steven Y. Chang, Rebecca Beutler, Trisha Agarwal, Julia Vargas, Marc Moss, Amiran Baduashvili, Lakshmi Chauhan, Lani L. Finck, Michelle Howell, Robert C. Hyzy, Pauline K. Park, Kristine Nelson, Jake I. McSparron, Ivan N. Co, Bonnie R. Wang, Shijing Jia, Barbara Sullins, Sinan Hanna, Norman Olbrich, Lynne D. Richardson, Rahul Nair, Obiageli Offor, Brenda Lopez, Omowunmi Amosu, Hiwet Tzehaie, Thomas E. Terndrup, Herbert P. Wiedemann, Abhijit Duggal, Nirosshan Thiruchelvam, Kiran Ashok, Alexander H. King, Omar Mehkri, Kristin Hudock, Simra Kiran, Harshada More, Tammy Roads, Jamie Martinkovic, Sarah Kennedy, Bryce H. Robinson, Catherine L. Hough, Olivia F. Krol, Mistry Kinjal, Emmanuel Mills, Madeline McDougal, Rupali Deshmukh, Peter Chen, Sam S. Torbati, Yuri Matusov, June Choe, Niree A. Hindoyan, Susan E. Jackman, Emad Bayoumi, Timothy Wynter, Antonina Caudill, Ethan Pascual, Gregg J. Clapham, Lisa Herrera, Cristabelle Ojukwu, Shaunt Mehdikhani, D. Shane O'Mahony, Sonam T. Nyatsatsang, David M. Wilson, Julie A. Wallick, Chadwick Miller, Keven W. Gibbs, Lori S. Flores, Mary E. LaRose, Leigha D. Landreth, Peter E. Morris, Jamie L. Sturgill, Evan P. Cassity, Sanjay Dhar, Ashley A. Montgomery-Yates, Sara N. Pasha, Kirby P. Mayer, Brittany Bissel, Joseph Bledsoe, Samuel Brown, Michael Lanspa, Lindsey Leither, Brent P. Armbruster, Quinn Montgomery, Darrin Applegate, Naresh Kumar, Melissa Fergus, Erna Serezlic, Karah Imel, Ghazal Palmer, Brandon Webb, Valerie T. Aston, Jakea Johnson, Christopher Gray, Margaret Hays, Megan Roth, Adriana Sánchez, Laura Popielski, Heather Rivasplata, Melissa Turner, Michael Vjecha, Tianna Petersen, Dena Kamel, Laura Hansen, Claudia Sanchez Lucas, Natalie DellaValle, Sonia Gonzales, James Scott, David Wyles, Ivor Douglas, Jason Haukoos, Kevin Kamis, Caitlin Robinson, Jason V. Baker, Anne Frosch, Rachael Goldsmith, Hodan Jibrell, Melanie Lo, Jonathan Klaphake, Shari Mackedanz, Linh Ngo, Kelly Garcia-Myers, Norman Markowitz, Erika Pastor, Mayur Ramesh, Indira Brar, Emanuel Rivers, Princy Kumar, Maximiliano Menna, Kousick Biswas, Cristin Harrington, Alex Delp, Lavannya Pandit, Casey Hines-Munson, John Van, Laura Dillon, Yiqun Want, Paola Lichtenberger, Gio Baracco, Carol Ramos, Lauren Bjork, Melyssa Sueiro, Phyllis Tien, Heather Freasier, Theresa Buck, Hafida Nekach, Stephanie Nagy-Agren, Shikha Vasudeva, Tracy Ochalek, Brentin Roller, Chinh Nguyen, Amani Mikail, Dorthe Raben, Tomas O. Jensen, Bitten Aagaard, Charlotte B. Nielsen, Katharina Krapp, Bente Rosdahl Nykjær, Katja Lisa Kanne, Anne Louise Grevsen, Zillah Maria Joensen, Tina Bruun, Ane Bojesen, Frederik Woldbye, Nick E. Normand, Frederik V.L. Esmann, Clara Lundetoft Clausen, Nichlas Hovmand, Karen Brorup Pedersen, Louise Thorlacius-Ussing, Michaela Tinggaard, Dorthe S. Høgsberg, Ema Rastoder, Thobias Kamstrup, Christina Marisa Bergsøe, Lars Østergaard, Nina Breinholt Stærke, Isik S. Johansen, Fredrikke C. Knudtzen, Lykke Larsen, Mathias A. Hertz, Thilde Fabricius, Marie Helleberg, Jan Gerstoft, Tomas Østergaard Jensen, Birgitte Lindegaard, Thomas Ingemann Pedersen, Birgit Thorup Røge, Sandra Valborg Løfberg, Thomas Michael Hansen, Ariella Denize Nielsen, Sebastian Leicht von Huth, Henrik Nielsen, Rikke Krog Thisted, Daria Podlekareva, Stine Johnsen, Helle Frost Andreassen, Lars Pedersen, Cecilia Ebba Clara Ellinor Lindnér, Lothar Wiese, Lene Surland Knudsen, Nikolaj Julian Skrøder Nytofte, Signe Ravn Havmøller, Roger Paredes, Maria Exposito, Eduardo Fernández-Cruz, José Muñoz, Jose R. Arribas, Vicente Estrada, Juan P. Horcajada, Joaquin Burgos, Jose Luis Morales-Rull, Dominique L. Braun, Emily West, Khadija M'Rabeth-Bensalah, Mareile L. Eichinger, Manuela Grüttner-Durmaz, Christina Grube, Veronika Zink, Andrzej Horban, Agnieszka Bednarska, Natalia Jurek, Gerd Fätkenheuer, Jakob J. Malinm, Gail Matthews, Anthony Kelleher, Gesalit Cabrera, Catherine Carey, Sally Hough, Sophie Virachit, Amy Zhong, Barnaby E. Young, Po Ying Chia, Tau Hong Lee, Ray J. Lin, David Lye, Sean Ong, Ser Hon Puah, Tsin Wen Yeo, Shiau Hui Diong, Juwinda Ongko, Fleur Hudson, Mahesh KB Parmar, Anna Goodman, Jonathan Badrock, Adam Gregory, Nicola Harris, Giota Touloumi, Nikos Pantaz, Vicky Gioukari, Joseph Lutaakome, Cissy M. Kityo, Henry Mugerwa, Francis Kiweewa, Anu Osinusi, Craig Tipple, Angela Willis, Amanda Peppercorn, Helen Watson, Elizabeth Alexander, Erik Mogalian, Leo Lin, Xiao Ding, Li Yan, Jean-Luc Girardet, Ji Ma, Zhi Hong, Amy Adams, Sara Albert, Abby Balde, Michelle Baracz, Beth Baseler, Nancy Becker, Mona Bielica, Shere Billouin-Frazier, Jennifer Cash, Jay Choudhary, Suzanne Dolney, Mary Dixon, Carolyn Eyler, Leanna Frye, Michael Galcik, Jensen Gertz, Lisa Giebeig, Neelam Gulati, Liz Hankinson, Debbie Hissey, Debi Hogarty, Matt Hohn, H Preston Holley, Lisa Hoopengardner, Lynda Huber, Shirley Jankelevich, Gary Krauss, Eileen Lake, Jessica Linton, Leah MacDonald, Meryan Manandhar, Mary Spinelli-Nadzam, Charles Oluremi, Calvin Proffitt, Erin Rudzinski, Jen Sandrus, Marylu Schaffhauser, Adam Schechner, Connie Suders, Norman P. Gerry, Kenneth Smith, Courtney Solomon, Amanda Kubernac, Marium Rashid, Bhakti Patel, Robert Kubernac, Joseph Murphy, Marie L. Hoover, Craig Brown, Nadine DuChateau, Adam Flosi, Les Johnson, Amy Treagus, and Christine Wenner

Subjects
Adult, Male, Adolescent, SARS-CoV-2, Comment, COVID-19, Antibodies, Monoclonal, Articles, Middle Aged, Antibodies, Monoclonal, Humanized, Antibodies, Neutralizing, COVID-19/drug therapy, COVID-19 Drug Treatment, Hospitalization, Infectious Diseases, Antineoplastic Agents, Immunological, Treatment Outcome, Antibodies, Monoclonal, Humanized/therapeutic use, Double-Blind Method, Humans, Female, Aged
Abstract

BACKGROUND: We aimed to assess the efficacy and safety of two neutralising monoclonal antibody therapies (sotrovimab [Vir Biotechnology and GlaxoSmithKline] and BRII-196 plus BRII-198 [Brii Biosciences]) for adults admitted to hospital for COVID-19 (hereafter referred to as hospitalised) with COVID-19.METHODS: In this multinational, double-blind, randomised, placebo-controlled, clinical trial (Therapeutics for Inpatients with COVID-19 [TICO]), adults (aged ≥18 years) hospitalised with COVID-19 at 43 hospitals in the USA, Denmark, Switzerland, and Poland were recruited. Patients were eligible if they had laboratory-confirmed SARS-CoV-2 infection and COVID-19 symptoms for up to 12 days. Using a web-based application, participants were randomly assigned (2:1:2:1), stratified by trial site pharmacy, to sotrovimab 500 mg, matching placebo for sotrovimab, BRII-196 1000 mg plus BRII-198 1000 mg, or matching placebo for BRII-196 plus BRII-198, in addition to standard of care. Each study product was administered as a single dose given intravenously over 60 min. The concurrent placebo groups were pooled for analyses. The primary outcome was time to sustained clinical recovery, defined as discharge from the hospital to home and remaining at home for 14 consecutive days, up to day 90 after randomisation. Interim futility analyses were based on two seven-category ordinal outcome scales on day 5 that measured pulmonary status and extrapulmonary complications of COVID-19. The safety outcome was a composite of death, serious adverse events, incident organ failure, and serious coinfection up to day 90 after randomisation. Efficacy and safety outcomes were assessed in the modified intention-to-treat population, defined as all patients randomly assigned to treatment who started the study infusion. This study is registered with ClinicalTrials.gov, NCT04501978.FINDINGS: Between Dec 16, 2020, and March 1, 2021, 546 patients were enrolled and randomly assigned to sotrovimab (n=184), BRII-196 plus BRII-198 (n=183), or placebo (n=179), of whom 536 received part or all of their assigned study drug (sotrovimab n=182, BRII-196 plus BRII-198 n=176, or placebo n=178; median age of 60 years [IQR 50-72], 228 [43%] patients were female and 308 [57%] were male). At this point, enrolment was halted on the basis of the interim futility analysis. At day 5, neither the sotrovimab group nor the BRII-196 plus BRII-198 group had significantly higher odds of more favourable outcomes than the placebo group on either the pulmonary scale (adjusted odds ratio sotrovimab 1·07 [95% CI 0·74-1·56]; BRII-196 plus BRII-198 0·98 [95% CI 0·67-1·43]) or the pulmonary-plus complications scale (sotrovimab 1·08 [0·74-1·58]; BRII-196 plus BRII-198 1·00 [0·68-1·46]). By day 90, sustained clinical recovery was seen in 151 (85%) patients in the placebo group compared with 160 (88%) in the sotrovimab group (adjusted rate ratio 1·12 [95% CI 0·91-1·37]) and 155 (88%) in the BRII-196 plus BRII-198 group (1·08 [0·88-1·32]). The composite safety outcome up to day 90 was met by 48 (27%) patients in the placebo group, 42 (23%) in the sotrovimab group, and 45 (26%) in the BRII-196 plus BRII-198 group. 13 (7%) patients in the placebo group, 14 (8%) in the sotrovimab group, and 15 (9%) in the BRII-196 plus BRII-198 group died up to day 90.INTERPRETATION: Neither sotrovimab nor BRII-196 plus BRII-198 showed efficacy for improving clinical outcomes among adults hospitalised with COVID-19.FUNDING: US National Institutes of Health and Operation Warp Speed.

Published
2022
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3. Rationale and Design of ORCHID: A Randomized Placebo-controlled Clinical Trial of Hydroxychloroquine for Adults Hospitalized with COVID-19

Author

Nathan I. Shapiro, Cathryn F. Oldmixon, Michelle N. Gong, Todd W. Rice, John Eppensteiner, Michael R. Filbin, Nancy Ringwood, Matthew W. Semler, David A. Schoenfeld, Douglas Hayden, Jay S. Steingrub, Kevin W Gibbs, Christopher J. Lindsell, Frank E. Harrell, Neil R. Aggarwal, Nicholas J. Johnson, Lora A. Reineck, Lindsay M. Leither, Catherine L. Hough, Akram Khan, Bryce R.H. Robinson, Roy G. Brower, B. Taylor Thompson, Pauline K. Park, Sean P. Collins, Steven Y. Chang, Wesley H. Self, Samuel M. Brown, Alexandra Weissman, Jonathan D Casey, Adit A. Ginde, Marc Moss, and Donna K Torr

Subjects
Pulmonary and Respiratory Medicine, medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), business.industry, Hydroxychloroquine, Disease, Placebo, law.invention, Clinical trial, 03 medical and health sciences, 0302 clinical medicine, 030228 respiratory system, Randomized controlled trial, law, Informed consent, Pandemic, Medicine, 030212 general & internal medicine, business, Intensive care medicine, medicine.drug
Abstract

The ORCHID (Outcomes Related to COVID-19 treated with Hydroxychloroquine among In-patients with symptomatic Disease) trial is a multicenter, blinded, randomized trial of hydroxychloroquine versus placebo for the treatment of adults hospitalized with coronavirus disease (COVID-19). This document provides the rationale and background for the trial and highlights key design features. We discuss five novel challenges to the design and conduct of a large, multicenter, randomized trial during a pandemic, including 1) widespread, off-label use of the study drug before the availability of safety and efficacy data; 2) the need to adapt traditional procedures for documentation of informed consent during an infectious pandemic; 3) developing a flexible and robust Bayesian analysis incorporating significant uncertainty about the disease, outcomes, and treatment; 4) obtaining indistinguishable drug and placebo without delaying enrollment; and 5) rapidly obtaining administrative and regulatory approvals. Our goals in describing how the ORCHID trial progressed from study conception to enrollment of the first patient in 15 days are to inform the development of other high-quality, multicenter trials targeting COVID-19. We describe lessons learned to improve the efficiency of future clinical trials, particularly in the setting of pandemics. The ORCHID trial will provide high-quality, clinically relevant data on the safety and efficacy of hydroxychloroquine for the treatment of COVID-19 among hospitalized adults.Clinical trial registered with www.clinicaltrials.gov (NCT04332991).

Published
2020
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4. Monitoring Research Blood Sampling in Critically Ill Patients: Avoiding Iatrogenic Anemia

Author

Nancy Ringwood, Bryan J. McVerry, Robert Paine, Eric P. Schmidt, Nathan I. Shapiro, Mark M. Wurfel, Wesley H. Self, R. Duncan Hite, John W. Christman, Kathleen D. Liu, Michael A. Matthay, Rebecca M. Baron, and Peter W. Adams

Subjects
Adult, Male, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Anemia, Critical Illness, Iatrogenic Disease, MEDLINE, Critical Care and Intensive Care Medicine, Correspondence, medicine, Humans, Intensive care medicine, Aged, Aged, 80 and over, Blood Specimen Collection, business.industry, Critically ill, Middle Aged, medicine.disease, Practice Guidelines as Topic, Critical illness, Female, business, Biological Monitoring, Blood sampling
Published
2020
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5. Effect of Early High-Dose Vitamin D3 Repletion on Cognitive Outcomes in Critically Ill Adults

Author

Mayur B. Patel, Adrienne Baughman, Nancy Ringwood, Daniel Talmor, Wesley H. Self, Matthew W. Semler, Samuel M. Brown, Onur M Orun, Jin H. Han, Catherine L. Hough, Aluko A. Hope, Rameela Raman, Akram Khan, Peter C. Hou, Nathan I. Shapiro, Theodore J. Iwashyna, Michelle N. Gong, Todd W. Rice, E. Wesley Ely, Adit A. Ginde, James C. Jackson, and Erin M. Collar

Subjects
Pulmonary and Respiratory Medicine, Vitamin, Male, Repeatable Battery for the Assessment of Neuropsychological Status, medicine.medical_specialty, Critical Illness, Long Term Adverse Effects, Neuropsychological Tests, Critical Care and Intensive Care Medicine, Placebo, vitamin D deficiency, law.invention, 03 medical and health sciences, chemistry.chemical_compound, Executive Function, 0302 clinical medicine, Cognition, Randomized controlled trial, law, Interquartile range, Internal medicine, medicine, Vitamin D and neurology, Humans, Cognitive Dysfunction, 030212 general & internal medicine, Cholecalciferol, business.industry, Vitamins, Middle Aged, medicine.disease, Vitamin D Deficiency, Treatment Outcome, 030228 respiratory system, chemistry, Pulse Therapy, Drug, Critical Care: Original Research, Female, Cardiology and Cardiovascular Medicine, business, Delis–Kaplan Executive Function System
Abstract

Background Long-term cognitive impairment frequently occurs after critical illness; no treatments are known to improve long-term cognition. Research Question Does a single high-dose (540,000 International Units) enteral treatment of vitamin D3 given shortly after hospital admission in critically ill patients who are vitamin D deficient improve long-term global cognition or executive function? Study Design and Methods This study evaluated long-term cognitive outcomes among patients enrolled in a multicenter, blinded, randomized clinical trial comparing vitamin D3 treatment vs placebo in critically ill adults with vitamin D deficiency. Global cognition was measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). Executive function was measured with a composite score derived from three Delis-Kaplan Executive Function System subscales. Outcomes were assessed at a median of 443 days (interquartile range, 390-482 days) after randomization and were compared using multivariate proportional odds regression. Adjusted ORs of > 1.0 would indicate better outcomes in the vitamin D3 group compared with the placebo group. Results Ninety-five patients were enrolled, including 47 patients randomized to vitamin D3 treatment and 48 patients randomized to placebo. The adjusted median RBANS score at follow-up was 79.6 (95% CI, 73.0-84.0) in the vitamin D3 group and 82.1 (95% CI, 74.7-84.6) in the placebo group (adjusted OR, 0.83; 95% CI, 0.50-1.38). The adjusted median executive function composite scores were 8.1 (95% CI, 6.8-9.0) and 8.7 (95% CI, 7.4-9.3), respectively (adjusted OR, 0.72; 95% CI, 0.36-1.42). Interpretation In vitamin D-deficient, critically-ill adults, a large dose of enteral vitamin D3 did not improve long-term global cognition or executive function. Trial Registry ClinicalTrials.gov; No.: NCT03733418; URL: www.clinicaltrials.gov

Published
2021

6. 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

7. Early High-Dose Vitamin D

Author

Adit A, Ginde, Roy G, Brower, Jeffrey M, Caterino, Lani, Finck, Valerie M, Banner-Goodspeed, Colin K, Grissom, Douglas, Hayden, Catherine L, Hough, Robert C, Hyzy, Akram, Khan, Joseph E, Levitt, Pauline K, Park, Nancy, Ringwood, Emanuel P, Rivers, Wesley H, Self, Nathan I, Shapiro, B Taylor, Thompson, Donald M, Yealy, and Laurie S, Zoloth

Subjects
Vitamin, Adult, Male, medicine.medical_specialty, Organ Dysfunction Scores, Critical Illness, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, Gastroenterology, vitamin D deficiency, Treatment failure, Article, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Double-Blind Method, Internal medicine, medicine, Vitamin D and neurology, Humans, 030212 general & internal medicine, Treatment Failure, Vitamin D, Cholecalciferol, Extramural, business.industry, Critically ill, General Medicine, Vitamins, Length of Stay, Middle Aged, medicine.disease, Vitamin D Deficiency, Clinical trial, Multicenter study, chemistry, Female, business
Abstract

BACKGROUND: Vitamin D deficiency is a common, potentially reversible contributor to morbidity and mortality among critically ill patients. The potential benefits of vitamin D supplementation in acute critical illness require further study. METHODS: We conducted a randomized, double-blind, placebo-controlled, phase 3 trial of early vitamin D(3) supplementation in critically ill, vitamin D-deficient patients who were at high risk for death. Randomization occurred within 12 hours after the decision to admit the patient to an intensive care unit. Eligible patients received a single enteral dose of 540,000 IU of vitamin D(3) or matched placebo. The primary end point was 90-day all-cause, all-location mortality. RESULTS: A total of 1360 patients were found to be vitamin D-deficient during point-of-care screening and underwent randomization. Of these patients, 1078 had baseline vitamin D deficiency (25-hydroxyvitamin D level

Published
2019

8. Fluid Management With a Simplified Conservative Protocol for the Acute Respiratory Distress Syndrome*

Author

G. Netzer, Joyce Lanier, N. Lavery, K. Liu, Carolyn S. Calfee, Daryl J. Kor, K. Hodgin, Rana Hejal, P. Lauto, M. Andrews, Dale M. Needham, L. Bezdijan, Timothy E Albertson, E. L. Warren, D. Schoenfeld, Brian M. Daniel, S. Bredow, Anita J. Reddy, Mark D. Eisner, K. Sundar, S. Brown, W. Beninati, C. Lawton, Russell R. Miller, K. Ludwig, S. Brierre, Daniel A. Culver, Christopher E. Cox, N. Bolouri, S. Jain, Venkata Bandi, C. Kardos, A. Harvey, Nancy Ringwood, D. Charbonnet, C. Romaine, D. Herr, Steven R Holets, P. Sloane, P. Lazar, Polly P. Bailey, David A. Schoenfeld, Mark Tidswell, S. Ouellette, J. McLean, Ellen L. Burnham, Kathleen D. Liu, Richard F. Hinds, A. Stowe, L. Kozikowski, Jay S. Steingrub, R. W. Ashton, J. J. Komara, G. Meyaski, Gordon R. Bernard, Herbert P. Wiedemann, Leonardo Seoane, T. Bost, Lisa M. Brown, E. Hirshberg, M. Waclawiw, T. Beck, Henry E. Fessler, T. Frederick, G. Simpson, D. Eckley, J. Byrne, Colin K. Grissom, J. Ferguson, C. Oldmixon, K. Bender, Joseph A. Govert, R. Tanaka, Burton W. Lee, J. Titus, Oscar Garcia, E. Vlastelin, C. Hebert, Michael A Gentile, John P. Hunt, Bennett P. deBoisblanc, K. Moreau, J. Thompson, Jorge A. Guzman, W. Hall, J. Germain, K. Overdier, C. Thomas, D. Hanselman, James F. Orme, D. Haney, L. Gray, Justin Dickerson, Alfred F. Connors, Daniel R. Brown, R. Morse, D. Ward, Catherine L. Hough, Anna Ungar, E. Hammond, N. Kumar, Eliotte L. Hirshberg, R. Wolken, Pedro A. Mendez-Tellez, Roy G. Brower, C. Bishop, Emir Festic, Rolf D. Hubmayr, H. Gallo, Kalpatha Guntupalli, K. Thompson, J. Blaauw, Summer Choudhury, Art Wheeler, C. Ross, Brian M. Morrissey, T. Hill, B. T. Thompson, J. Fearon, Nancy W. Knudsen, Lydia Chang, H. Highfield, E. Braden, C. Higgins, N. Shum, Peter Rock, Shannon S. Carson, H. Howes, L. DeSouza, Melissa A. Passe, J. Wright, Jonathon D. Truwit, Gail Weinmann, Marc Moss, C. LeBlanc, Stephanie J. Gundel, K. Kordesch, Susan Mogan, A. Workneh, Frank Thomas, Lindell K. Weaver, S. Groce, Timothy R. Watkins, D. Taylor, H. Zhou, T. Graydon, Terry P. Clemmer, M. Dubin, Jonathan E. Sevransky, A. Overton, C. Shanholtz, Mary Faith Marshall, Elizabeth Smoot, R. D. Hite, S. Barney, Todd W. Rice, S. Lasalvia, A. Antoine, M. Guha, K. Oakjones, R. Duncan Hite, C. Grissom, R. Miller, J. Maloney, S. Frankel, W. Alward, A. Austin, Leonard D. Hudson, Al Jephson, R. Tejedor, Samuel M. Brown, J. D. Thornton, Mary Ragusky, Neil R. MacIntyre, Augustine S. Lee, D. Murphy, L. Struck, Michael A. Matthay, Alan H. Morris, S. King, J. McKeehan, M. L. Warner, S. Rimkus, D. Kelley, Alan B. Marr, Richard Wilson, K. Van Gundy, Meredith Mealer, Michael W. Peterson, David N. Hager, C. Pope, Michael J. Lanspa, Ivor S. Douglas, P. Rock, M. Tidswell, M. Pearce, Andrea L. Harabin, Kathryn A. Sims, T. Jagneaux, F. Simeone, B. Jensen, Ognjen Gajic, P. Wright, Margaret A. Hays, Kyle B. Enfield, D. Nielsen, A. Morris, A. Sampaio, Margaret J. Neff, and Peter E. Morris

Subjects
Male, medicine.medical_specialty, Central Venous Pressure, Fluid management, Acute respiratory distress, Critical Care and Intensive Care Medicine, Random Allocation, Clinical Protocols, Treatment trial, Furosemide, medicine, Humans, Diuretics, Intensive care medicine, Retrospective Studies, Protocol (science), Respiratory Distress Syndrome, business.industry, Central venous pressure, Acute kidney injury, Shock, Retrospective cohort study, Middle Aged, Water-Electrolyte Balance, medicine.disease, Respiration, Artificial, United States, Intensive Care Units, Catheter, Fluid Therapy, Female, business
Abstract

In the Fluid and Catheter Treatment Trial (FACTT) of the National Institutes of Health Acute Respiratory Distress Syndrome Network, a conservative fluid protocol (FACTT Conservative) resulted in a lower cumulative fluid balance and better outcomes than a liberal fluid protocol (FACTT Liberal). Subsequent Acute Respiratory Distress Syndrome Network studies used a simplified conservative fluid protocol (FACTT Lite). The objective of this study was to compare the performance of FACTT Lite, FACTT Conservative, and FACTT Liberal protocols.Retrospective comparison of FACTT Lite, FACTT Conservative, and FACTT Liberal. Primary outcome was cumulative fluid balance over 7 days. Secondary outcomes were 60-day adjusted mortality and ventilator-free days through day 28. Safety outcomes were prevalence of acute kidney injury and new shock.ICUs of Acute Respiratory Distress Syndrome Network participating hospitals.Five hundred three subjects managed with FACTT Conservative, 497 subjects managed with FACTT Liberal, and 1,124 subjects managed with FACTT Lite.Fluid management by protocol.Cumulative fluid balance was 1,918 ± 323 mL in FACTT Lite, -136 ± 491 mL in FACTT Conservative, and 6,992 ± 502 mL in FACTT Liberal (p0.001). Mortality was not different between groups (24% in FACTT Lite, 25% in FACTT Conservative and Liberal, p = 0.84). Ventilator-free days in FACTT Lite (14.9 ± 0.3) were equivalent to FACTT Conservative (14.6 ± 0.5) (p = 0.61) and greater than in FACTT Liberal (12.1 ± 0.5, p0.001 vs Lite). Acute kidney injury prevalence was 58% in FACTT Lite and 57% in FACTT Conservative (p = 0.72). Prevalence of new shock in FACTT Lite (9%) was lower than in FACTT Conservative (13%) (p = 0.007 vs Lite) and similar to FACTT Liberal (11%) (p = 0.18 vs Lite).FACTT Lite had a greater cumulative fluid balance than FACTT Conservative but had equivalent clinical and safety outcomes. FACTT Lite is an alternative to FACTT Conservative for fluid management in Acute Respiratory Distress Syndrome.

Published
2015
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9. Point prevalence study of mobilization practices for acute respiratory failure patients in the United States

Author

Peter E. Morris, Sarah E. Jolley, Dale M. Needham, Nancy Ringwood, Catherine L. Hough, Megan Anders, Stephanie E. Gundel, Russell R. Miller, Marc Moss, Karen K. Koo, Ellen Caldwell, and Selina M Parry

Subjects
medicine.medical_specialty, Icu patients, Rehabilitation, Mobilization, Cross-sectional study, business.industry, medicine.medical_treatment, Prevalence, 030208 emergency & critical care medicine, Critical Care and Intensive Care Medicine, Intensive care unit, Article, law.invention, 03 medical and health sciences, 0302 clinical medicine, law, medicine, Acute respiratory failure, 030212 general & internal medicine, Intensive care medicine, business, Intensive care unit acquired weakness
Abstract

Objective:Early mobility in mechanically ventilated patients is safe, feasible, and may improve functional outcomes. We sought to determine the prevalence and character of mobility for ICU patients with acute respiratory failure in U.S. ICUs.Design:Two-day cross-sectional point prevalence study.Sett

Published
2017

10. Statistical design and analysis issues for the ARDS Clinical Trials Network: the Coordinating Center perspective

Author

Cathryn F. Oldmixon, Nancy Ringwood, David A. Schoenfeld, B. Taylor Thompson, and Douglas Hayden

Subjects
ARDS, medicine.medical_specialty, Randomization, Early stopping, Statistical design, business.industry, General Medicine, medicine.disease, Treatment efficacy, Clinical trial, Sample size determination, Covariate, medicine, Intensive care medicine, business
Abstract

We describe the statistical design principals for clinical trials conducted by the Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network that is funded by the National Heart Lung and Blood Institute. These include the definition of ARDS used by the network, the choice of measures of treatment efficacy, the choice of sample size, eligibility criteria, the choice of data to collect, stratification and randomization, the use of factorial trials and coenrollment of patients on more than one trial, early stopping for futility and efficacy, the choice of control group, the control of cointerventions, treatment administration and covariate adjustment.

Published
2012
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11. Randomized, placebo-controlled trial of lisofylline for early treatment of acute lung injury and acute respiratory distress syndrome

Author

David A. Schoenfeld, Marion Gray Secundy, Thomas M. Hyera, M. A. Matthay, Robert H. Bartlett, John M. Luce, Roger G. Spragg, Kenneth P. Steinberg, Dawn Kalous, Edward Abraham, Leonard D. Hudson, Neil R. MacIntyre, David C. Thompson, Kenneth Leeper, Gail Wenzlow, Steven Dahlberg, Carolyn Paradise, Thomas Jefferson, Janice D'Hulst, Mark Sebastian, Myron Waclawiw, William J. Sibbald, Ron Dechert, Roy G. Brower, Charles Watts, Paul N. Lanken, Michael A. Gryzner, John Komara, Carolyn H. Welsh, Scott S. Emerson, Joe G N Garcia, Francine Molay, Aimee Girod, Susan K. Pingleton, Douglas Hayden, Barbara Finkel, Pamela Randall, Henry J. Silverman, Galen B. Toews, Dorothy B. Gail, James Orme, Nancy Ringwood, Jason Kelley, Charles B. Lawton, Chris Stevens, Lee Mallatratt, B. Taylor Thompson, Alejandro C. Arroliga, Richard Kallet, Gordon R. Bernard, Marek Ancukiewicz, Herbert P. Wiedemann, Andrea L. Harabin, Brian Daniel, Terry Clemmer, Arthur S. Slutsky, John D. Lockrem, Ronald V. Maier, Michael Matthay, Robert Sladen, Carroll Wilcox, Alan H. Morris, Wanda Corral, Deborah Arnoldi, Arthur P. Wheeler, Libby Stone, Robin M Davis, Harry Anderson, Fran Piedalue, Polly E. Parsons, Carolyn Smith, C. William Hanson, Carol H. Bosken, V. A. Denver, Michael D. Shasby, James M. Boyett, Christine Walberg, Claudette Lee, Gordon Bernard, Robert C. McIntyre, William J. Fulkerson, and Jonathan E. Gottlieb

Subjects
Lung Diseases, Respiratory Distress Syndrome, business.industry, Anti-Inflammatory Agents, Non-Steroidal, Placebo-controlled study, Acute respiratory distress, Lung injury, Fatty Acids, Nonesterified, Critical Care and Intensive Care Medicine, chemistry.chemical_compound, chemistry, Double-Blind Method, Anesthesia, Medicine, Humans, Prospective Studies, Pentoxifylline, business, Diffuse alveolar damage, Infusions, Intravenous, Lisofylline
Abstract

To determine whether the administration of lisofylline (1-[5R-hydroxyhexyl]-3,7-dimethylxanthine) would decrease mortality in patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS).A prospective, randomized, double-blind, placebo-controlled, multicenter study.Intensive care units at 21 hospitals at the ten centers constituting the ARDS Clinical Trials Network.A total of 235 patients who met eligibility criteria were enrolled in the study (116 into the lisofylline group, 119 into the placebo group).Patients were randomized to receive either lisofylline or placebo. The dose of lisofylline was 3 mg/kg with a maximum dose of 300 mg intravenously every 6 hrs. The intravenous solution of study drug was administered over 10 mins every 6 hrs. Dosing was continued for 20 days or until the patient achieved 48 hrs of unassisted breathing.The trial was stopped by the Data Safety Monitoring Board for futility at the first scheduled interim analysis. The patient groups had similar characteristics at enrollment. No significant safety concerns were associated with lisofylline therapy. There was no significant difference between groups in the number of patients who had died at 28 days (31.9% lisofylline vs. 24.7% placebo, p = .215). There was no significant difference between the lisofylline and placebo groups in terms of resolution of organ failures, ventilator-free days, infection-related deaths, or development of serious infection during the 28-day study period. The median number of organ failure-free days for the five nonpulmonary organ failures examined (cardiovascular, central nervous system, coagulation, hepatic, and renal) was not different between the lisofylline and placebo groups. Although lisofylline has been reported to decrease circulating free fatty acid levels, we did not find any such treatment effect compared with placebo.In this study, there was no evidence that lisofylline had beneficial effects in the treatment of established ALI/ARDS.

Published
2002

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