Passive Immunity Trial for Our Nation (PassITON): study protocol for a randomized placebo-control clinical trial evaluating COVID-19 convalescent plasma in hospitalized adults.
Wesley H SelfThomas G StewartAllison P WheelerWissam El AtrouniAmanda J Bistran-HallJonathan D CaseyVince D CataldoJames D ChappellClaudia S CohnJessica B CollinsMark R DenisonMaijolein de WitSheri L DixonAbhijit DuggalTerri L EdwardsMagali J FontaineAdit A GindeMichelle S HarkinsThelma HarringtonEstelle S HarrisDaanish HodaTina S IpeStuti J JaiswalNicholas J JohnsonAlan E JonesMaryrose Laguio-VilaChristopher J LindsellJason MalladaManoj J MammenRyan A MetcalfElizabeth A MiddletonSimon MuchaHollis R O'NealSonal R PannuJill M PulleyXian QiaoJay S RavalJillian P RhoadsHarry SchragerCarl ShanholtzNathan I ShapiroStephen J SchrantzIsaac ThomsenKrista K VermillionGordon R BernardTodd W RicePublished in: Research square (2021)
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.
Keyphrases
- sars cov
- coronavirus disease
- phase iii
- clinical trial
- respiratory syndrome coronavirus
- double blind
- placebo controlled
- phase ii
- study protocol
- end stage renal disease
- ejection fraction
- newly diagnosed
- chronic kidney disease
- open label
- computed tomography
- prognostic factors
- magnetic resonance
- stem cells
- randomized controlled trial
- risk factors
- adipose tissue
- magnetic resonance imaging
- metabolic syndrome
- cardiovascular events
- physical activity
- combination therapy
- hepatitis b virus
- early onset
- squamous cell carcinoma
- radiation therapy
- patient reported outcomes
- coronary artery disease
- drug induced
- cross sectional
- intensive care unit
- weight loss
- image quality