Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, 1313 21st Ave South, 312 Oxford House, Nashville, TN, 37232, USA.
Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, USA.
Trials. 2021 Mar 20;22(1):221. doi: 10.1186/s13063-021-05171-2.
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.
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.
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.
ClinicalTrials.gov NCT04362176 . Registered on 24 April 2020.
恢复期血浆正被广泛用于治疗 2019 年冠状病毒病（COVID-19）。然而，COVID-19 恢复期血浆的临床疗效尚不清楚。
美国正在进行一项多中心、安慰剂对照、盲法、随机临床试验——被动免疫试验（PassITON），旨在提供 COVID-19 恢复期血浆治疗有症状住院成人患者的疗效的高质量证据。有呼吸道症状且症状出现时间不足 14 天的 COVID-19 住院成人患者有资格参加。纳入的患者以 1:1 的比例随机分配接受 1 单位（200-399ml）COVID-19 恢复期血浆，该血浆使用 SARS-CoV-2 嵌合病毒中和测定法显示具有中和功能。以盲法方式给予研究治疗，患者随访 28 天。主要结局是研究治疗后 14 天的临床状态，采用 7 级序数量表评估死亡率、呼吸支持和恢复日常生活活动能力。主要次要结局包括死亡率和无吸氧天数。该试验预计纳入 1000 例患者，旨在检测主要结局的比值比≤0.73。
该试验将提供迄今为止 COVID-19 恢复期血浆治疗急性中重度 COVID-19 住院成人患者疗效的最可靠数据。这些数据将有助于指导当前大流行期间 COVID-19 患者的治疗，并为是否需要建立一个用于收集和分发恢复期血浆的标准化基础设施以应对未来的病毒性大流行做出决策提供依据。
ClinicalTrials.gov NCT04362176。于 2020 年 4 月 24 日注册。
