Passive Immunity Trial for Our Nation (PassITON): study protocol for a randomized placebo-control clinical trial evaluating COVID-19 convalescent plasma in hospitalized adults

Self, Wesley H.; Stewart, Thomas G.; Wheeler, Allison P.; El Atrouni, Wissam; Bistran-Hall, Amanda J.; Casey, Jonathan D.; Cataldo, Vince D.; Chappell, James D.; Cohn, Claudia S.; Collins, Jessica B.; Denison, Mark R.; de Wit, Marjolein; Dixon, Sheri L.; Duggal, Abhijit; Edwards, Terri L.; Fontaine, Magali J.; Ginde, Adit A.; Harkins, Michelle S.; Harrington, Thelma; Harris, Estelle S.; Hoda, Daanish; Ipe, Tina S.; Jaiswal, Stuti J.; Johnson, Nicholas J.; Jones, Alan E.; Laguio-Vila, Maryrose; Lindsell, Christopher J.; Mallada, Jason; Mammen, Manoj J.; Metcalf, Ryan A.; Middleton, Elizabeth A.; Mucha, Simon; O’Neal, Hollis R.; Pannu, Sonal R.; Pulley, Jill M.; Qiao, Xian; Raval, Jay S.; Rhoads, Jillian P.; Schrager, Harry; Shanholtz, Carl; Shapiro, Nathan I.; Schrantz, Stephen J.; Thomsen, Isaac; Vermillion, Krista K.; Bernard, Gordon R.; Rice, Todd W.

BACKGROUND: Convalescent 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. METHODS: The 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. DISCUSSION: This 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 REGISTRATION: ClinicalTrials.gov NCT04362176. Registered on 24 April 2020. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05171-2.