Passive Immunity Trial for Our Nation (PassITON): Study Protocol for a Randomized Placebo-Control Clinical Trial Evaluating COVID-19 Convalescent Plasma in Hospitalized Adults
Department
Infectious Diseases
Document Type
Article
Publication Title
Trials
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 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.
First Page
221
DOI
10.1186/s13063-021-05171-2
Volume
22
Issue
1
Publication Date
3-2-2021
PubMed ID
33743799
Recommended Citation
Self, W. H., Stewart, T. G., Wheeler, A. P., El Atrouni, W., Bistran-Hall, A. J., Casey, J. D., Cataldo, V. D., Chappell, J. D., Cohn, C. S., Collins, J. B., Denison, M. R., de Wit, M., Dixon, S. L., Duggal, A., Edwards, T. L., Fontaine, M. J., Ginde, A. A., Harkins, M. S., Harrington, T., Harris, E. S., Hoda, D., Ipe, T. S., Jaiswal, S. J., Johnson, N. J., Jones, A. E., Laguio-Vila, M., Lindsell, C. J., Mallada, J., Mammen, M., Metcalf, R. A., Middleton, E. A., Mucha, S., O'Neal, H. R., Pannu, S. R., Pulley, J. M., Qiao, X., Raval, J. S., Rhoads, J. P., Schrager, H., Shanholtz, C., Shapiro, N. I., Schrantz, S. J., Thomsen, I., Vermillion, K. K., Bernard, G. R., & Rice, T. W. (2021). Passive Immunity Trial for Our Nation (PassITON): Study Protocol for a Randomized Placebo-Control Clinical Trial Evaluating COVID-19 Convalescent Plasma in Hospitalized Adults. Trials, 22 (1), 221. https://doi.org/10.1186/s13063-021-05171-2