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

For the Passive Immunity Trial for Our Nation (PassITON) Investigators

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9 Scopus citations

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.

Original languageEnglish (US)
Article number221
JournalTrials
Volume22
Issue number1
DOIs
StatePublished - Dec 2021

Bibliographical note

Funding Information:
Primary funding for this work was provided by the NCATS award 3UL1TR002243-04S3. Funding for REDCap, trial innovation work, and the other tools was provided by NCATS award No. UL1TR002243. Funding for pilot work was provided by the Dolly Parton COVID-19 Research Fund.

Funding Information:
The PassITON trial launched in April 2020 as a single-center study at Vanderbilt University Medical Center with funding from the Dolly Parton COVID-19 Research Fund. The trial expanded to a multicenter study in August 2020 with funding from the NCATS of the National Institutes of Health (NIH). Prior to expansion to the multicenter format, 66 participants had been enrolled at Vanderbilt. Interim analyses conducted by the independent DSMB after enrollment and completion of the primary outcome by 151 and 469 study participants resulted in recommendations to continue the study without modification. PassITON is currently enrolling under protocol version 5.0 dated September 15, 2020. Trial completion is expected by May 31, 2021. Acknowledgements Disclaimer

Publisher Copyright:
© 2021, The Author(s).

Keywords

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

PubMed: MeSH publication types

  • Clinical Trial Protocol
  • Journal Article

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