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 Pass ive I mmunity T rial for O ur N ation (PassITON), is a multicenter, placebo-controlled, blinded, randomized clinical trial being conducted in the United States 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. Date of trial registration: April 24, 2020, https://clinicaltrials.gov/ct2/show/NCT04362176.
RCT Entities:
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 Pass ive I mmunity T rial for O ur N ation (PassITON), is a multicenter, placebo-controlled, blinded, randomized clinical trial being conducted in the United States 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-19patients 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. Date of trial registration: April 24, 2020, https://clinicaltrials.gov/ct2/show/NCT04362176.
Authors: Michael J Joyner; Rickey E Carter; Jonathon W Senefeld; Stephen A Klassen; John R Mills; Patrick W Johnson; Elitza S Theel; Chad C Wiggins; Katelyn A Bruno; Allan M Klompas; Elizabeth R Lesser; Katie L Kunze; Matthew A Sexton; Juan C Diaz Soto; Sarah E Baker; John R A Shepherd; Noud van Helmond; Nicole C Verdun; Peter Marks; Camille M van Buskirk; Jeffrey L Winters; James R Stubbs; Robert F Rea; David O Hodge; Vitaly Herasevich; Emily R Whelan; Andrew J Clayburn; Kathryn F Larson; Juan G Ripoll; Kylie J Andersen; Matthew R Buras; Matthew N P Vogt; Joshua J Dennis; Riley J Regimbal; Philippe R Bauer; Janis E Blair; Nigel S Paneth; DeLisa Fairweather; R Scott Wright; Arturo Casadevall Journal: N Engl J Med Date: 2021-01-13 Impact factor: 91.245
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Authors: Seth J Zost; Pavlo Gilchuk; Rita E Chen; James Brett Case; Joseph X Reidy; Andrew Trivette; Rachel S Nargi; Rachel E Sutton; Naveenchandra Suryadevara; Elaine C Chen; Elad Binshtein; Swathi Shrihari; Mario Ostrowski; Helen Y Chu; Jonathan E Didier; Keith W MacRenaris; Taylor Jones; Samuel Day; Luke Myers; F Eun-Hyung Lee; Doan C Nguyen; Ignacio Sanz; David R Martinez; Paul W Rothlauf; Louis-Marie Bloyet; Sean P J Whelan; Ralph S Baric; Larissa B Thackray; Michael S Diamond; Robert H Carnahan; James E Crowe Journal: Nat Med Date: 2020-07-10 Impact factor: 87.241
Authors: James Brett Case; Paul W Rothlauf; Rita E Chen; Zhuoming Liu; Haiyan Zhao; Arthur S Kim; Louis-Marie Bloyet; Qiru Zeng; Stephen Tahan; Lindsay Droit; Ma Xenia G Ilagan; Michael A Tartell; Gaya Amarasinghe; Jeffrey P Henderson; Shane Miersch; Mart Ustav; Sachdev Sidhu; Herbert W Virgin; David Wang; Siyuan Ding; Davide Corti; Elitza S Theel; Daved H Fremont; Michael S Diamond; Sean P J Whelan Journal: Cell Host Microbe Date: 2020-07-03 Impact factor: 21.023
Authors: Peter Horby; Wei Shen Lim; Jonathan R Emberson; Marion Mafham; Jennifer L Bell; Louise Linsell; Natalie Staplin; Christopher Brightling; Andrew Ustianowski; Einas Elmahi; Benjamin Prudon; Christopher Green; Timothy Felton; David Chadwick; Kanchan Rege; Christopher Fegan; Lucy C Chappell; Saul N Faust; Thomas Jaki; Katie Jeffery; Alan Montgomery; Kathryn Rowan; Edmund Juszczak; J Kenneth Baillie; Richard Haynes; Martin J Landray Journal: N Engl J Med Date: 2020-07-17 Impact factor: 91.245