Passive Immunity Trial for Our Nation (PassITON): study protocol for a randomized placebo-control clinical trial evaluating COVID-19 convalescent plasma in hospitalized adults.
Passive Immunity Trial for Our Nation (PassITON): study protocol for a randomized placebo-control clinical trial evaluating COVID-19 convalescent plasma in hospitalized adults.
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DOI：
10.1186/s13063-021-05171-2
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发表时间：
2021-03-20
期刊：
影响因子：
2.5
通讯作者：
Passive Immunity Trial for Our Nation (PassITON) Investigators
中科院分区：
文献类型：
--
作者：
Self WH;Stewart TG;Wheeler AP;El Atrouni W;Bistran-Hall AJ;Casey JD;Cataldo VD;Chappell JD;Cohn CS;Collins JB;Denison MR;de Wit M;Dixon SL;Duggal A;Edwards TL;Fontaine MJ;Ginde AA;Harkins MS;Harrington T;Harris ES;Hoda D;Ipe TS;Jaiswal SJ;Johnson NJ;Jones AE;Laguio-Vila M;Lindsell CJ;Mallada J;Mammen MJ;Metcalf RA;Middleton EA;Mucha S;O'Neal HR Jr;Pannu SR;Pulley JM;Qiao X;Raval JS;Rhoads JP;Schrager H;Shanholtz C;Shapiro NI;Schrantz SJ;Thomsen I;Vermillion KK;Bernard GR;Rice TW;Passive Immunity Trial for Our Nation (PassITON) Investigators
康复期血浆被广泛用于治疗2019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。我们国家的被动免疫试验（Passive Immunity Trial for Our Nation，PassITON）是一项在美国进行的多中心、安慰剂对照、盲法、随机临床试验，旨在为COVID-19恢复期血浆治疗因症状性疾病住院的成年人的疗效提供高质量的证据。患有COVID-19并有呼吸道症状住院少于14天的成年人符合资格。入组的患者以1：1的比例随机分配至1单位（200-399 mL）COVID-19恢复期血浆，该血浆已使用SARS-CoV-2嵌合病毒中和试验证明具有中和功能。研究治疗以盲法方式施用，并对患者随访28天。主要结局是研究治疗后14天的临床状态，采用7类顺序量表评估死亡率、呼吸支持和恢复正常日常生活活动。关键次要结局包括死亡率和无氧天数。该试验预计入组1000例患者，旨在检测主要结局的比值比≤ 0.73。这项试验将提供迄今为止关于COVID-19恢复期血浆治疗急性中度至重度COVID-19住院成人的疗效的最可靠数据。这些数据将有助于指导当前大流行中COVID-19患者的治疗，并有助于决定是否需要开发标准化基础设施，用于收集和传播恢复期血浆，为未来的病毒大流行做准备。ClinicalTrials.gov NCT 04362176。于二零二零年四月二十四日注册。在线版本包含补充材料，可通过10.1186/s13063-021-05171-2获得。
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. The online version contains supplementary material available at 10.1186/s13063-021-05171-2.
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影响因子：
30.3
作者：
Case, James Brett;Rothlauf, Paul W.;Whelan, Sean P. J.
通讯作者：
Whelan, Sean P. J.
DOI：
10.1056/nejmoa2035389
发表时间：
2021-02-04
期刊：
The New England journal of medicine
影响因子：
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作者：
Baden LR;El Sahly HM;Essink B;Kotloff K;Frey S;Novak R;Diemert D;Spector SA;Rouphael N;Creech CB;McGettigan J;Khetan S;Segall N;Solis J;Brosz A;Fierro C;Schwartz H;Neuzil K;Corey L;Gilbert P;Janes H;Follmann D;Marovich M;Mascola J;Polakowski L;Ledgerwood J;Graham BS;Bennett H;Pajon R;Knightly C;Leav B;Deng W;Zhou H;Han S;Ivarsson M;Miller J;Zaks T;COVE Study Group
通讯作者：
COVE Study Group
影响因子：
158.5
作者：
Ginde, Adit A.;Brower, Roy G.;Talmor, Daniel
通讯作者：
Talmor, Daniel
DOI：
10.1056/nejmoa2031893
发表时间：
2021-03-18
期刊：
The New England journal of medicine
影响因子：
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作者：
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通讯作者：
Casadevall A
影响因子：
8.6
作者：
Casadevall, A
通讯作者：
Casadevall, A