Title

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 General Hospital
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

Research Square

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.

DOI

10.21203/rs.3.rs-227796/v1

Publication Date

3-2-2021

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