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

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 Pass ive I mmunity T rial for O ur N ation (PassITON), is a multicenter, placebo-controlled, blinded, randomized clinical trial being conducted in the United States 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 Date of trial registration: April 24, 2020, https://clinicaltrials gov/ct2/show/NCT04362176