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

Christopher J. Lindsell¹  Thomas G. Stewart¹  Simon Mucha²  Abhijit Duggal²  Nathan I. Shapiro³  Adit A. Ginde⁴  Alan E. Jones⁵  Nicholas J. Johnson⁶  Maryrose Laguio-Vila⁷  Claudia S. Cohn⁸  Jonathan D. Casey⁹  Stephen J. Schrantz^1,10  Michelle S. Harkins^1,11  Tina S. Ipe^1,12  Allison P. Wheeler^1,13  Jay S. Raval^1,14  Ryan A. Metcalf^1,15  Jason Mallada^1,16  Vince D. Cataldo^1,17  Stuti J. Jaiswal^1,18  Wissam El Atrouni^1,19  Isaac Thomsen^2,20  Mark R. Denison^2,20  James D. Chappell^2,20  Marjolein de Wit^2,21  Thelma Harrington^2,22  Carl Shanholtz^2,22  Elizabeth A. Middleton^2,23  Estelle S. Harris^2,23  Hollis R. O’Neal^2,24  Manoj J. Mammen^2,25  Sonal R. Pannu^2,26  Magali J. Fontaine^2,27  Daanish Hoda^2,28  Harry Schrager^2,29  Xian Qiao^3,30  Krista K. Vermillion^3,31  Amanda J. Bistran-Hall^3,31  Sheri L. Dixon^3,31  Jillian P. Rhoads^3,31  Terri L. Edwards^3,31  Jessica B. Collins^3,31  Jill M. Pulley^3,31  Wesley H. Self^3,32  Todd W. Rice^3,33  Gordon R. Bernard^3,33 

[1] Department of Biostatistics, Vanderbilt University Medical Center, Nashville, USA;Department of Critical Care, Respiratory Institute, Cleveland Clinical Healthcare System, Cleveland, USA;Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Boston, USA;Department of Emergency Medicine, University of Colorado School of Medicine, Boulder, USA;Department of Emergency Medicine, University of Mississippi Medical Center, Oxford, USA;Department of Emergency and Division of Pulmonary, Critical Care, and Sleep Medicine, University of Washington, Seattle, USA;Department of Internal Medicine, Division of Infectious Disease, Rochester General Hospital, Rochester, USA;Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, USA;Department of Medicine, Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, USA;Department of Medicine, University of Chicago, Chicago, USA;Department of Medicine, University of New Mexico School of Medicine, Albuquerque, USA;Department of Pathology and Laboratory Medicine, University of Arkansas for Medical Sciences, Fayetteville, USA;Department of Pathology, Microbiology, and Immunology, Vanderbilt University Medical Center, Nashville, USA;Department of Pathology, University of New Mexico School of Medicine, Albuquerque, USA;Department of Pathology, University of Utah, Salt Lake City, USA;Department of Pharmacy, Newton-Wellesley Hospital, Massachusetts College of Pharmacy and Health Sciences, Boston, USA;Division of Hematology and Oncology, Louisiana State University Health-Sciences Center, New Orleans, USA;Division of Hospital Medicine, Scripps Clinic, Scripps Research Translational Institute, The Scripps Research Institute, San Diego, USA;Division of Infectious Diseases, Department of Internal Medicine, The University of Kansas School of Medicine, Kasas, USA;Division of Infectious Diseases, Department of Pediatrics, Vanderbilt University Medical Center, Nashville, USA;Division of Pulmonary Disease and Critical Care Medicine, Department of Internal Medicine, Virginia Commonwealth University, Richmond, USA;Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Maryland School of Medicine, College Park, USA;Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Utah, Salt Lake City, USA;Division of Pulmonary and Critical Care, Louisiana State University Health-Sciences Center, New Orleans, USA;Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, State University of New York at Buffalo, Buffalo, USA;Division of Pulmonary, Critical Care, and Sleep Medicine, The Ohio State University, Columbus, USA;Division of Transfusion Services, Department of Pathology, University of Maryland School of Medicine, Baltimore, USA;Intermountain Healthcare, Salt Lake City, USA;Newton-Wellesley Hospital, Department of Medicine, Tufts School of Medicine, Boston, USA;Sentara Pulmonary, Critical Care, and Sleep Specialists, Sentara Health, Eastern Virginia Medical School, Norfolk, USA;Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, 1313 21st Ave South, 312 Oxford House, 37232, Nashville, TN, USA;Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, 1313 21st Ave South, 312 Oxford House, 37232, Nashville, TN, USA;Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, USA;Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, 1313 21st Ave South, 312 Oxford House, 37232, Nashville, TN, USA;Department of Medicine, Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, USA;

关键词: COVID-19;    SARS-CoV-2: convalescent plasma;    Passive immunity;    Neutralizing antibodies;    Clinical trials;    Randomized controlled trial;   

DOI  :  10.1186/s13063-021-05171-2

来源: Springer

【 摘 要 】

BackgroundConvalescent 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.MethodsThe 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.DiscussionThis 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 registrationClinicalTrials.gov NCT04362176. Registered on 24 April 2020.

【 授权许可】

CC BY