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

• Wesley H. Self, Vanderbilt University Medical Center
• Thomas G. Stewart, Vanderbilt University Medical Center
• Allison P. Wheeler, Vanderbilt University Medical Center, Nashville, Tennessee
• Wissam El Atrouni, University of Kansas School of Medicine
• Amanda J. Bistran-Hall, Vanderbilt University Medical Center
• Jonathan D. Casey, Vanderbilt University Medical Center
• Vince D. Cataldo, Louisiana State University Health Sciences Center
• James D. Chappell, Vanderbilt University Medical Center
• Claudia S. Cohn, University of Minnesota
• Jessica B. Collins, Vanderbilt University Medical Center
• Mark R. Denison, Vanderbilt University Medical Center
• Maijolein de Wit, Virginia Commonwealth University
• Sheri L. Dixon, Vanderbilt University Medical Center
• Abhijit Duggal, Cleveland Clinic Health System
• Terri L. Edwards, Vanderbilt University Medical Center
• Magali J. Fontaine, University of Maryland School of Medicine
• Adit A. Ginde, University of Colorado Denver School of Medicine
• Michelle S. Harkins, University of New Mexico School of Medicine
• Thelma Harrington, University of Maryland School of Medicine
• Estelle S. Harris, University of Utah
• Daanish Hoda, Intermountain Healthcare
• Tina S. Ipe, University of Arkansas for Medical Sciences
• Stuti J. Jaiswal, The Scripps Research Institute
• Nicholas J. Johnson, University of Washington
• Alan E. Jones, The University of Mississippi Medical Center
• Maryrose Laguio-Vila, Rochester Regional HealthFollow
• Christopher J. Lindsell, Vanderbilt University Medical Center
• Jason Mallada, Newton-Wellesley Hospital
• Manoj J. Mammen, State University of New York at Buffalo: University at Buffalo
• Ryan A. Metcalf, University of Utah
• Elizabeth A. Middleton, University of Utah
• Simon Mucha, Cleveland Clinic Health System
• Hollis R. O'Neal, Louisiana State University Health Sciences Center
• Sonal R. Pannu, The Ohio State University
• Jill M. Pulley, Vanderbilt University Medical Center
• Xian Qiao, Eastern Virginia Medical School
• Jay S. Raval, University of New Mexico School of Medicine
• Jillian P. Rhoads, Vanderbilt University Medical Center
• Harry Schrager, Newton-Wellesley Hospital
• Carl Shanholtz, University of Maryland School of Medicine
• Nathan I. Shapiro, Beth Israel Deaconess Medical Center
• Stephen J. Schrantz, University of Chicago Department of Medicine
• Isaac Thomsen, Vanderbilt University Medical Center
• Krista K. Vermillion, Vanderbilt University Medical Center
• Gordon R. Bernard, Vanderbilt University Medical Center
• Todd W. Rice, Vanderbilt University Medical Center

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