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Passive Immunity Trial for Our Nation (PassITON): study protocol for a randomized placebo-control clinical trial evaluating COVID-19 convalescent plasma in hospitalized adults.
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; Harris, Estelle S; Hoda, Daanish; Ipe, Tina S; Jaiswal, Stuti J; Johnson, Nicholas J; Jones, Alan E; Laguio-Vila, Maryrose; Lindsell, Christopher J; Mallada, Jason; Mammen, Manoj J; Metcalf, Ryan A; Middleton, Elizabeth A; Mucha, Simon; O'Neal, Hollis R; Pannu, Sonal R; Pulley, Jill M; Qiao, Xian; Raval, Jay S; Rhoads, Jillian P; Schrager, Harry; Shanholtz, Carl; Shapiro, Nathan I; Schrantz, Stephen J; Thomsen, Isaac; Vermillion, Krista K; Bernard, Gordon R; Rice, Todd W.
Afiliación
  • Self WH; 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.
  • Stewart TG; Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, USA. wesley.self@vumc.org.
  • Wheeler AP; Department of Biostatistics, Vanderbilt University Medical Center, Nashville, USA.
  • El Atrouni W; Department of Pathology, Microbiology, and Immunology, Vanderbilt University Medical Center, Nashville, USA.
  • Bistran-Hall AJ; Division of Infectious Diseases, Department of Internal Medicine, The University of Kansas School of Medicine, Kasas, USA.
  • Casey JD; Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, 1313 21st Ave South, 312 Oxford House, Nashville, TN, 37232, USA.
  • Cataldo VD; Department of Medicine, Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, USA.
  • Chappell JD; Division of Hematology and Oncology, Louisiana State University Health-Sciences Center, New Orleans, USA.
  • Cohn CS; Division of Infectious Diseases, Department of Pediatrics, Vanderbilt University Medical Center, Nashville, USA.
  • Collins JB; Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, USA.
  • Denison MR; Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, 1313 21st Ave South, 312 Oxford House, Nashville, TN, 37232, USA.
  • de Wit M; Division of Infectious Diseases, Department of Pediatrics, Vanderbilt University Medical Center, Nashville, USA.
  • Dixon SL; Division of Pulmonary Disease and Critical Care Medicine, Department of Internal Medicine, Virginia Commonwealth University, Richmond, USA.
  • Duggal A; Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, 1313 21st Ave South, 312 Oxford House, Nashville, TN, 37232, USA.
  • Edwards TL; Department of Critical Care, Respiratory Institute, Cleveland Clinical Healthcare System, Cleveland, USA.
  • Fontaine MJ; Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, 1313 21st Ave South, 312 Oxford House, Nashville, TN, 37232, USA.
  • Ginde AA; Division of Transfusion Services, Department of Pathology, University of Maryland School of Medicine, Baltimore, USA.
  • Harkins MS; Department of Emergency Medicine, University of Colorado School of Medicine, Boulder, USA.
  • Harrington T; Department of Medicine, University of New Mexico School of Medicine, Albuquerque, USA.
  • Harris ES; Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Maryland School of Medicine, College Park, USA.
  • Hoda D; Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Utah, Salt Lake City, USA.
  • Ipe TS; Intermountain Healthcare, Salt Lake City, USA.
  • Jaiswal SJ; Department of Pathology and Laboratory Medicine, University of Arkansas for Medical Sciences, Fayetteville, USA.
  • Johnson NJ; Division of Hospital Medicine, Scripps Clinic, Scripps Research Translational Institute, The Scripps Research Institute, San Diego, USA.
  • Jones AE; Department of Emergency and Division of Pulmonary, Critical Care, and Sleep Medicine, University of Washington, Seattle, USA.
  • Laguio-Vila M; Department of Emergency Medicine, University of Mississippi Medical Center, Oxford, USA.
  • Lindsell CJ; Department of Internal Medicine, Division of Infectious Disease, Rochester General Hospital, Rochester, USA.
  • Mallada J; Department of Biostatistics, Vanderbilt University Medical Center, Nashville, USA.
  • Mammen MJ; Department of Pharmacy, Newton-Wellesley Hospital, Massachusetts College of Pharmacy and Health Sciences, Boston, USA.
  • Metcalf RA; Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, State University of New York at Buffalo, Buffalo, USA.
  • Middleton EA; Department of Pathology, University of Utah, Salt Lake City, USA.
  • Mucha S; Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Utah, Salt Lake City, USA.
  • O'Neal HR; Department of Critical Care, Respiratory Institute, Cleveland Clinical Healthcare System, Cleveland, USA.
  • Pannu SR; Division of Pulmonary and Critical Care, Louisiana State University Health-Sciences Center, New Orleans, USA.
  • Pulley JM; Division of Pulmonary, Critical Care, and Sleep Medicine, The Ohio State University, Columbus, USA.
  • Qiao X; Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, 1313 21st Ave South, 312 Oxford House, Nashville, TN, 37232, USA.
  • Raval JS; Sentara Pulmonary, Critical Care, and Sleep Specialists, Sentara Health, Eastern Virginia Medical School, Norfolk, USA.
  • Rhoads JP; Department of Pathology, University of New Mexico School of Medicine, Albuquerque, USA.
  • Schrager H; Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, 1313 21st Ave South, 312 Oxford House, Nashville, TN, 37232, USA.
  • Shanholtz C; Newton-Wellesley Hospital, Department of Medicine, Tufts School of Medicine, Boston, USA.
  • Shapiro NI; Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Maryland School of Medicine, College Park, USA.
  • Schrantz SJ; Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Boston, USA.
  • Thomsen I; Department of Medicine, University of Chicago, Chicago, USA.
  • Vermillion KK; Division of Infectious Diseases, Department of Pediatrics, Vanderbilt University Medical Center, Nashville, USA.
  • Bernard GR; Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, 1313 21st Ave South, 312 Oxford House, Nashville, TN, 37232, USA.
  • Rice TW; Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, 1313 21st Ave South, 312 Oxford House, Nashville, TN, 37232, USA.
Trials ; 22(1): 221, 2021 Mar 20.
Article en En | MEDLINE | ID: mdl-33743799
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: SARS-CoV-2 / COVID-19 / Hospitalización Tipo de estudio: Clinical_trials / Diagnostic_studies / Guideline / Prognostic_studies / Qualitative_research Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: SARS-CoV-2 / COVID-19 / Hospitalización Tipo de estudio: Clinical_trials / Diagnostic_studies / Guideline / Prognostic_studies / Qualitative_research Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido