Trials (Mar 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
- Wesley H. Self,
- Thomas G. Stewart,
- Allison P. Wheeler,
- Wissam El Atrouni,
- Amanda J. Bistran-Hall,
- Jonathan D. Casey,
- Vince D. Cataldo,
- James D. Chappell,
- Claudia S. Cohn,
- Jessica B. Collins,
- Mark R. Denison,
- Marjolein de Wit,
- Sheri L. Dixon,
- Abhijit Duggal,
- Terri L. Edwards,
- Magali J. Fontaine,
- Adit A. Ginde,
- Michelle S. Harkins,
- Thelma Harrington,
- Estelle S. Harris,
- Daanish Hoda,
- Tina S. Ipe,
- Stuti J. Jaiswal,
- Nicholas J. Johnson,
- Alan E. Jones,
- Maryrose Laguio-Vila,
- Christopher J. Lindsell,
- Jason Mallada,
- Manoj J. Mammen,
- Ryan A. Metcalf,
- Elizabeth A. Middleton,
- Simon Mucha,
- Hollis R. O’Neal,
- Sonal R. Pannu,
- Jill M. Pulley,
- Xian Qiao,
- Jay S. Raval,
- Jillian P. Rhoads,
- Harry Schrager,
- Carl Shanholtz,
- Nathan I. Shapiro,
- Stephen J. Schrantz,
- Isaac Thomsen,
- Krista K. Vermillion,
- Gordon R. Bernard,
- Todd W. Rice,
- For the Passive Immunity Trial for Our Nation (PassITON) Investigators
Affiliations
- Wesley H. Self
- Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center
- Thomas G. Stewart
- Department of Biostatistics, Vanderbilt University Medical Center
- Allison P. Wheeler
- Department of Pathology, Microbiology, and Immunology, Vanderbilt University Medical Center
- Wissam El Atrouni
- Division of Infectious Diseases, Department of Internal Medicine, The University of Kansas School of Medicine
- Amanda J. Bistran-Hall
- Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center
- Jonathan D. Casey
- Department of Medicine, Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center
- Vince D. Cataldo
- Division of Hematology and Oncology, Louisiana State University Health-Sciences Center
- James D. Chappell
- Division of Infectious Diseases, Department of Pediatrics, Vanderbilt University Medical Center
- Claudia S. Cohn
- Department of Laboratory Medicine and Pathology, University of Minnesota
- Jessica B. Collins
- Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center
- Mark R. Denison
- Division of Infectious Diseases, Department of Pediatrics, Vanderbilt University Medical Center
- Marjolein de Wit
- Division of Pulmonary Disease and Critical Care Medicine, Department of Internal Medicine, Virginia Commonwealth University
- Sheri L. Dixon
- Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center
- Abhijit Duggal
- Department of Critical Care, Respiratory Institute, Cleveland Clinical Healthcare System
- Terri L. Edwards
- Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center
- Magali J. Fontaine
- Division of Transfusion Services, Department of Pathology, University of Maryland School of Medicine
- Adit A. Ginde
- Department of Emergency Medicine, University of Colorado School of Medicine
- Michelle S. Harkins
- Department of Medicine, University of New Mexico School of Medicine
- Thelma Harrington
- Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Maryland School of Medicine
- Estelle S. Harris
- Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Utah
- Daanish Hoda
- Intermountain Healthcare
- Tina S. Ipe
- Department of Pathology and Laboratory Medicine, University of Arkansas for Medical Sciences
- Stuti J. Jaiswal
- Division of Hospital Medicine, Scripps Clinic, Scripps Research Translational Institute, The Scripps Research Institute
- Nicholas J. Johnson
- Department of Emergency and Division of Pulmonary, Critical Care, and Sleep Medicine, University of Washington
- Alan E. Jones
- Department of Emergency Medicine, University of Mississippi Medical Center
- Maryrose Laguio-Vila
- Department of Internal Medicine, Division of Infectious Disease, Rochester General Hospital
- Christopher J. Lindsell
- Department of Biostatistics, Vanderbilt University Medical Center
- Jason Mallada
- Department of Pharmacy, Newton-Wellesley Hospital, Massachusetts College of Pharmacy and Health Sciences
- Manoj J. Mammen
- Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, State University of New York at Buffalo
- Ryan A. Metcalf
- Department of Pathology, University of Utah
- Elizabeth A. Middleton
- Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Utah
- Simon Mucha
- Department of Critical Care, Respiratory Institute, Cleveland Clinical Healthcare System
- Hollis R. O’Neal
- Division of Pulmonary and Critical Care, Louisiana State University Health-Sciences Center
- Sonal R. Pannu
- Division of Pulmonary, Critical Care, and Sleep Medicine, The Ohio State University
- Jill M. Pulley
- Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center
- Xian Qiao
- Sentara Pulmonary, Critical Care, and Sleep Specialists, Sentara Health, Eastern Virginia Medical School
- Jay S. Raval
- Department of Pathology, University of New Mexico School of Medicine
- Jillian P. Rhoads
- Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center
- Harry Schrager
- Newton-Wellesley Hospital, Department of Medicine, Tufts School of Medicine
- Carl Shanholtz
- Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Maryland School of Medicine
- Nathan I. Shapiro
- Department of Emergency Medicine, Beth Israel Deaconess Medical Center
- Stephen J. Schrantz
- Department of Medicine, University of Chicago
- Isaac Thomsen
- Division of Infectious Diseases, Department of Pediatrics, Vanderbilt University Medical Center
- Krista K. Vermillion
- Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center
- Gordon R. Bernard
- Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center
- Todd W. Rice
- Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center
- For the Passive Immunity Trial for Our Nation (PassITON) Investigators
- DOI
- https://doi.org/10.1186/s13063-021-05171-2
- Journal volume & issue
-
Vol. 22,
no. 1
pp. 1 – 13
Abstract
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.
Keywords
- COVID-19
- SARS-CoV-2: convalescent plasma
- Passive immunity
- Neutralizing antibodies
- Clinical trials
- Randomized controlled trial
