Efficacy and Safety of COVID-19 Convalescent Plasma in Hospitalized Patients

作者：Mila B. Ortigoza, Hyunah Yoon, Keith Goldfeld, Andrea B. Troxel, Johanna P. Daily, Yinxiang Wu, Yi Li, Danni Wu, Gia Cobb, Gillian Baptiste, Mary O’Keeffe, Marilou Corpuz, Luis Ostrosky‐Zeichner, Amee Amin, Ioannis M. Zacharioudakis, Dushyantha Jayaweera, Yanyun Wu, Julie V. Philley, Megan Devine, Mahalia S. Desruisseaux, Alessandro D. Santin, Shweta Anjan, Reeba Mathew, Bela Patel, Masayuki Nigo, Rabi Upadhyay, Tania Kupferman, Andrew Dentino, Rahul Nanchal, Christian A. Merlo, David N. Hager, Kartik Chandran, Jonathan R. Lai, Johanna Rivera, Chowdhury R. Bikash, Gorka Lasso, Timothy P. Hilbert, Monika Paroder, Andrea A. Asencio, Mengling Liu, Eva Petkova, Alexander Bragat, Reza Shaker, David D. McPherson, Ralph L. Sacco, Marla J. Keller, Corita R. Grudzen, Judith S. Hochman, Liise-anne Pirofski, Fatema Z Rahman, Adeyinka Ajayi, Sara L. Rodriguez, Ana G Ledesma, Deborah Keeling, Norka Rappoport, Sam F Ebel, Jayne Kim, Michelle Chang, Kevin M. Chan, Payal Patel, Anne Martocci, Shivang R. Dave, Yousef Darwish, Monica R Taveras, Victoria Shoyelu, Patrick Xin, Eduardo Iturrate, Lee C Moldolsky, Brian J Raimondo, Sarah Mendez, Patricia Hughes, Stephanie Sterling, Aaron Lord, Shadi Yaghi, Karen Veloso, Masooma Sheikh, Erica Visconti-Ferrara, Andrew J. Fleming, Heekoung Youn, Baby Jane Fran, Rosario Medina, Renee McKell, Saila Khan, Tanya Hamilton, Carlos J. Sánchez, Nandini H Patel, Levi G. Cleare, Olivia Vergnolle, Antonio Nakouzi, Gregory Quevedo, Robert H. Bortz, Ariel S. Wirchnianski, Catalina Florez, Rachelle Babb, Jennifer Ayala, K. Zoe Tsagaris, Andria James, Isaiah Eke, Aisha Obeidallah, Oana Sandu, Sophie Sohval, Leana Serrano‐Rahman, Joan Uehlinger, Rachel Bartash, Aya Al-Abduladheem, Inessa Gendlina, Carol Sheridan, Anna E. Bortnick, Jeremy Eichler, Rachel Kaufman, Sarah Yukelis, Michael J. Pennock, M J Goggin, Christine Shen, Jayabhargav Annam, Ahmed Khokhar, Daniel Barboto, Brianna J. Lally, Audrey Lee, Max Lee, Xiuyi A. Yang, Stephanie Allen, Avinash Malaviya, Osama Moussa, Rosa Park, Reise Sample, Andrea Bae, Galit Benoni, Lindsie Boerger, Lisa D Baker, Martha A. Luther, Lirim S Ameti, Neima Briggs, Marjorie R Golden, Michael V. Gormally, Gloria S. Huang, Raymond M. Johnson, Alyssa Morrison, Michele Montagna-Hill, Brooke N Rivera, Grace M Cortezzo, Kay B Debski, Nicoletti, Kerry DeBenedictis, Rivcah Davis, Christi E. Marshall, Miriam Andrea Duque Cuartas, Laura Beauchamps, Jovanna Bertran-Lopez, Jose Armando Gonzales Zamora, Maria Carolina Delgado-Lelievre, S. Dominguez, Chin Chin Lee, Halina Kusack, Vela Karakeshishyan, Americo Hajaz, Dasmany Deniz, Giovanni Garcia, Katheryn Dae, Patricia Blenet, Deborah R. Jaffe, Lourdes Olson, Diane Sabogal, Olivia Blust, Veronica Del Prete Perez, Claudia Bornia, Vanessa Rodriguez-Perez, V. Calderon, Rajan A. Ramdev, Aaliyah Jolly, Ivonne Guzman, Richard Guerra, Sebastian Brito, Rhonda Hobbs, Rebecca Denham, John Dick, María Dolores García Hernández, Laura E Nielsen, Sami M Anjum, Shelby C. Mader, Taylor P Stutz, Mehriban Mammadova, Pamela Nichols, Tanya S Khan, Maha Boktour, Brenda Emilia Castañeda Castañeda, Brenda D Benitez, Erik Hinojosa, Brenda C Guerra, Armando Ortiz, Renee Hebbeler-Clark, Pamela J. McShane, Rebekah Hibbard, Benji E Hawkins, Elizabeth Dohanich, Carly Wadle, K. Greenlee, Jennifer D. Brooks, Christopher Herrick, Amit Gode, Paul A. Bergl, Kurt Hu, Jayshil J. Patel, Shankar Srinivasan, Jeanette Graf, Char Klis, Kyersten Reimer, Erica L. Carpenter, Christine A. Naczek, Rae Petersen, Renee Dex, Jennifer Drossart, James Zelten, Charles D. Brummitt, Mengyao Liang, Lynda Yanny, Gary Dennison, Phyllis Runningen, Brian Brzezinski, Stephen Fiebig, Chris Naczek, Michelle Kasdorf, Lalitha Parameswaran, Anthony T. Corcoran, Abhinav Rohatgi, Marta Wrońska, Xinyuan Wu, Ranjini Srinivasan, Fang‐Ming Deng, Thomas D. Filardo, Jay Pendse, Simone B. Blaser, Olga Whyte, Jacqueline M Gallagher, Ololade E. Thomas, Danibel Ramos, Caroline L Sturm-Reganato, Charlotte C. Fong, Ivy M. Daus, Arianne Gisselle Payoen, Joseph T. Chiofolo, Mark T. Friedman, Ding Wen Wu, Jessica Jacobson, Jeffrey Schneider, Uzma Sarwar, Henry E. Wang, Ryan Huebinger, Goutham Dronavalli, Yu Bai, Carolyn Z. Grimes, Karen W. Eldin, Virginia Umana, Jessica Martin, Timothy R. Heath, Fatimah Bello, Daru Ransford, Maudry Laurent-Rolle, Sheela Shenoi, Oscar Bate Akide-Ndunge, Bipin Thapa, Jennifer Peterson, Kelly Knauf, Shivani Patel, Laura Cheney, Christopher A. Tormey, Jeanne E. Hendrickson · 发表于：JAMA Internal Medicine · 年份：2021 · DOI：10.1001/jamainternmed.2021.6850 · 被引用次数：93 · 研究领域：COVID-19 Clinical Research Studies、Long-Term Effects of COVID-19、SARS-CoV-2 and COVID-19 Research

Importance: There is clinical equipoise for COVID-19 convalescent plasma (CCP) use in patients hospitalized with COVID-19. Objective: To determine the safety and efficacy of CCP compared with placebo in hospitalized patients with COVID-19 receiving noninvasive supplemental oxygen. Design, Setting, and Participants: CONTAIN COVID-19, a randomized, double-blind, placebo-controlled trial of CCP in hospitalized adults with COVID-19, was conducted at 21 US hospitals from April 17, 2020, to March 15, 2021. The trial enrolled 941 participants who were hospitalized for 3 or less days or presented 7 or less days after symptom onset and required noninvasive oxygen supplementation. Interventions: A unit of approximately 250 mL of CCP or equivalent volume of placebo (normal saline). Main Outcomes and Measures: The primary outcome was participant scores on the 11-point World Health Organization (WHO) Ordinal Scale for Clinical Improvement on day 14 after randomization; the secondary outcome was WHO scores determined on day 28. Subgroups were analyzed with respect to age, baseline WHO score, concomitant medications, symptom duration, CCP SARS-CoV-2 titer, baseline SARS-CoV-2 serostatus, and enrollment quarter. Outcomes were analyzed using a bayesian proportional cumulative odds model. Efficacy of CCP was defined as a cumulative adjusted odds ratio (cOR) less than 1 and a clinically meaningful effect as cOR less than 0.8. Results: Of 941 participants randomized (473 to placebo and 468 to CC...