期刊
TRIALS
卷 22, 期 1, 页码 -出版社
BMC
DOI: 10.1186/s13063-021-05171-2
关键词
COVID-19; SARS-CoV-2: convalescent plasma; Passive immunity; Neutralizing antibodies; Clinical trials; Randomized controlled trial
资金
- NCATS [3UL1TR002243-04S3, UL1TR002243]
- Dolly Parton COVID-19 Research Fund
The PassITON trial in the USA aims to provide high-quality evidence on the efficacy of COVID-19 convalescent plasma for treating adults hospitalized with acute moderate to severe COVID-19. With a planned enrollment of 1000 patients, the trial is designed to provide the most robust data available on the treatment of COVID-19 patients.
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 14days are eligible. Enrolled patients are randomized in a 1:1 ratio to 1 unit (200-399mL) 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 28days. The primary outcome is clinical status 14days 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.
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