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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.; [...]

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

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  • Medientyp: E-Artikel
  • Titel: Passive Immunity Trial for Our Nation (PassITON): study protocol for a randomized placebo-control clinical trial evaluating COVID-19 convalescent plasma in hospitalized adults
  • Beteiligte: 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.; [...]
  • Erschienen: Springer Science and Business Media LLC, 2021
  • Erschienen in: Trials, 22 (2021) 1
  • Sprache: Englisch
  • DOI: 10.1186/s13063-021-05171-2
  • ISSN: 1745-6215
  • Schlagwörter: Pharmacology (medical) ; Medicine (miscellaneous)
  • Entstehung:
  • Hochschulschrift:
  • Anmerkungen:
  • Beschreibung: <jats:title>Abstract</jats:title><jats:sec> <jats:title>Background</jats:title> <jats:p>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.</jats:p> </jats:sec><jats:sec> <jats:title>Methods</jats:title> <jats:p>The <jats:italic>Pass</jats:italic>ive <jats:italic>I</jats:italic>mmunity <jats:italic>T</jats:italic>rial for <jats:italic>O</jats:italic>ur <jats:italic>N</jats:italic>ation (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.</jats:p> </jats:sec><jats:sec> <jats:title>Discussion</jats:title> <jats:p>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.</jats:p> </jats:sec><jats:sec> <jats:title>Trial registration</jats:title> <jats:p>ClinicalTrials.gov <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT04362176">NCT04362176</jats:ext-link>. Registered on 24 April 2020.</jats:p> </jats:sec>
  • Zugangsstatus: Freier Zugang