• Wesley H Self, Thomas G Stewart, Allison P Wheeler, Wissam El Atrouni, Amanda J Bistran-Hall, Jonathan D Casey, Vince D Cataldo, James D Chappell, Claudia S Cohn, Jessica B Collins, Mark R Denison, Marjolein de Wit, Sheri L Dixon, Abhijit Duggal, Terri L Edwards, Magali J Fontaine, Adit A Ginde, Michelle S Harkins, Thelma Harrington, Estelle S Harris, Daanish Hoda, Tina S Ipe, Stuti J Jaiswal, Nicholas J Johnson, Alan E Jones, Maryrose Laguio-Vila, Christopher J Lindsell, Jason Mallada, Manoj J Mammen, Ryan A Metcalf, Elizabeth A Middleton, Simon Mucha, Hollis R O'Neal, Sonal R Pannu, Jill M Pulley, Xian Qiao, Jay S Raval, Jillian P Rhoads, Harry Schrager, Carl Shanholtz, Nathan I Shapiro, Stephen J Schrantz, Isaac Thomsen, Krista K Vermillion, Gordon R Bernard, Todd W Rice, and Passive Immunity Trial for Our Nation (PassITON) Investigators.
• Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, 1313 21st Ave South, 312 Oxford House, Nashville, TN, 37232, USA. wesley.self@vumc.org.
• Trials. 2021 Mar 20; 22 (1): 221.

BackgroundConvalescent plasma is being used widely as a treatment for coronavirus disease 2019 (COVID-19). However, the clinical efficacy of COVID-19 convalescent plasma is unclear.MethodsThe Passive Immunity Trial for Our Nation (PassITON) is a multicenter, placebo-controlled, blinded, randomized clinical trial being conducted in the USA to provide high-quality evidence on the efficacy of COVID-19 convalescent plasma as a treatment for adults hospitalized with symptomatic disease. Adults hospitalized with COVID-19 with respiratory symptoms for less than 14 days are eligible. Enrolled patients are randomized in a 1:1 ratio to 1 unit (200-399 mL) of COVID-19 convalescent plasma that has demonstrated neutralizing function using a SARS-CoV-2 chimeric virus neutralization assay. Study treatments are administered in a blinded fashion and patients are followed for 28 days. The primary outcome is clinical status 14 days after study treatment as measured on a 7-category ordinal scale assessing mortality, respiratory support, and return to normal activities of daily living. Key secondary outcomes include mortality and oxygen-free days. The trial is projected to enroll 1000 patients and is designed to detect an odds ratio ≤ 0.73 for the primary outcome.DiscussionThis trial will provide the most robust data available to date on the efficacy of COVID-19 convalescent plasma for the treatment of adults hospitalized with acute moderate to severe COVID-19. These data will be useful to guide the treatment of COVID-19 patients in the current pandemic and for informing decisions about whether developing a standardized infrastructure for collecting and disseminating convalescent plasma to prepare for future viral pandemics is indicated.Trial RegistrationClinicalTrials.gov NCT04362176 . Registered on 24 April 2020.

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