Passive Immunity Trial for Our Nation (PassITON): study protocol for a randomized placebo-control clinical trial evaluating COVID-19 convalescent plasma in hospitalized adults

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

Trials. 2021;22(1):221
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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.
Study details
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine