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

AUTHORS

Self WH , Stewart TG , Wheeler AP , El Atrouni W , Bistran-Hall AJ , Casey JD , Cataldo VD , Chappell JD , Cohn CS , Collins JB , Denison MR , de Wit M , Dixon SL , Duggal A , Edwards TL , Fontaine MJ , Ginde AA , Harkins MS , Harrington T , Harris ES , Hoda D , Ipe TS , Jaiswal SJ , Johnson NJ , Jones AE , Laguio-Vila M , Lindsell CJ , Mallada J , Mammen MJ , Metcalf RA , Middleton EA , Mucha S , O'Neal HR , Pannu SR , Pulley JM , Qiao X , Raval JS , Rhoads JP , Schrager H , Shanholtz C , Shapiro NI , Schrantz SJ , Thomsen I , Vermillion KK , Bernard GR , Rice TW , , . Trials. 2021 03 20; 22(1). 221

PMID: 33743799 [PubMed].

ABSTRACT

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.