Convalescent Plasma to Limit Coronavirus Associated Complications: A Randomized Blinded Phase 2 Study Comparing the Efficacy and Safety of Anti-SARS-CoV-2 Plasma to Placebo in COVID-19 hospitalized pa

摘要 目前还没有任何科学证明或批准的治疗新冠肺炎的方法。恢复期血浆(CP)，它 从新冠肺炎康复者身上获得的血浆中含有SARS冠状病毒抗体- 2、引起这种疾病的病毒。CP在改善症状和死亡率方面有着悠久而传奇的历史 其他大流行性疾病，如1918年和2009年的流感和SARS，以及无数其他毒素-- 传播性和感染性疾病。因此，CP是一种合理的、容易获得的治疗方案 新冠肺炎。在纽约市地区，成千上万的新冠肺炎恢复者 捐献了他们的血浆来帮助其他患有这种疾病的人。该项目是一个协作性项目 随机、盲法、安慰剂对照试验评价住院患者慢性前列腺炎的疗效 与新冠肺炎合作，这项研究正在纽约大学(NYU)的三家朗格内健康医院进行 曼哈顿、布鲁克林和长岛、贝尔维尤医院中心和三蒙特菲奥里医疗中心(MMC) 布朗克斯的医院。我们设计并启动了这项试验，当时大流行在纽约市迅速发展 通过爱因斯坦-蒙特菲奥里和 纽约大学-朗格尼CTSA在纽约血液中心(NYBC)的支持下进行。支撑这一观点的假说 试验表明，与安慰剂相比，服用CP可以避免呼吸恶化，而呼吸恶化是导致死亡的主要原因 在新冠肺炎患者中。本项目的具体目标是：1)考察CP是否降低了 与安慰剂(生理盐水， SS)在给药后14天，以及2)确定SARS数量和质量之间的联系- 接受CP和安慰剂治疗的新冠肺炎住院患者的CoV-2抗体水平和临床结果。 证明CP对新冠肺炎有效的公共卫生效益，已导致338,000人感染 美国有21,845人死亡，纽约市有187,250人感染和1,127人死亡 巨大的公共卫生进步可以拯救数千人的生命。

ABSTRACT There are not any scientifically proven or approved therapies for COVID-19. Convalescent plasma (CP), which is plasma that is obtained from people who have recovered from COVID-19, contains antibodies to SARS-CoV- 2, the virus that causes this disease. CP has a long and storied history of improving symptoms and mortality from other pandemic diseases, such as 1918 and 2009 influenza and SARS, as well as a myriad of other toxin- mediated and infectious diseases. Thus, CP is a rationally based and readily available therapeutic option for COVID-19. There are thousands of people who have recovered from COVID-19 in the New York City area who have donated their plasma to help others who are suffering from this disease. This project is a collaborative randomized blinded placebo-controlled trial to evaluate the efficacy of treatment with CP in hospitalized patients with COVID-19 that is being conducted at three New York University (NYU) Langone Health hospitals in Manhattan, Brooklyn and Long Island, Bellevue Hospital Center, and three Montefiore Medical Center (MMC) hospitals in the Bronx. We designed and launched this trial as the pandemic surged in NYC by rapidly developing a multicenter, well-powered Phase 2 trial via regional collaborations established by Einstein-Montefiore and NYU-Langone CTSAs with support from the New York Blood Center (NYBC). The hypothesis underpinning the trial is that compared to placebo, administration of CP will avert respiratory deterioration, the main cause of death in patients with COVID-19. The specific aims of this project are: 1) To examine whether CP decreases the likelihood of respiratory deterioration in patients hospitalized for COVID-19 compared to placebo (saline solution, SS) at 14 days from administration, and 2) To identify associations between quantitative and qualitative SARS- CoV-2 antibody levels and clinical outcomes in patients hospitalized for COVID-19 who receive CP and placebo. The public health benefit of proof of CP efficacy against COVID-19, which has already caused 338,000 infections and 21,845 deaths in the United States and 187,250 infections and 1,127 deaths in New York City would be a tremendous and public health advance that could save thousands of lives.