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
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, LSU Health Sciences Center- New OrleansFollow
James D. Chappell, Vanderbilt University Medical Center
Claudia S. Cohn, University of Minnesota Twin Cities
Jessica B. Collins, Vanderbilt University Medical Center
Mark R. Denison, Vanderbilt University Medical Center
Marjolein de Wit, Virginia Commonwealth University
Sheri L. Dixon, Vanderbilt University Medical Center
Abhijit Duggal, Cleveland Clinic Foundation
Terri L. Edwards, Vanderbilt University Medical Center
Magali J. Fontaine, University of Maryland School of Medicine
Adit A. Ginde, University of Colorado School of Medicine
Michelle S. Harkins, UNM School of Medicine
Thelma Harrington, University of Maryland School of Medicine
Estelle S. Harris, The University of Utah

Document Type

Article

Publication Date

12-1-2021

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 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.

First Page

1

Last Page

13

PubMed ID

33743799

Volume

22

Issue

1

Publisher

BioMed Central

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Recommended Citation

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; and Harris, Estelle S., "Passive Immunity Trial for Our Nation (PassITON): Study Protocol for a Randomized Placebo-Control Clinical Trial Evaluating COVID-19 Convalescent Plasma in Hospitalized Adults" (2021). School of Medicine Faculty Publications. 92.
https://digitalscholar.lsuhsc.edu/som_facpubs/92

File Format

pdf

File Size

1675 KB