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

恢复期血浆限制冠状病毒相关并发症：一项随机盲法 2 期研究，比较抗 SARS-CoV-2 血浆与安慰剂在 COVID-19 住院患者中的功效和安全性

• 批准号: 10166008
• 负责人: MARLA J KELLER
• 金额: $ 432.52万
• 依托单位: ALBERT EINSTEIN COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-08 至 2023-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10166008
• 关键词: 2019-nCoV; Adult Respiratory Distress Syndrome; Antibodies; Area; Biological; Blinded; Blood; Blood Circulation; COVID-19; COVID-19 pandemic; Case Series; Cause of Death; Cessation of life; Clinical; Collaborations; Communicable Diseases; Consent Forms; Coronavirus; Deterioration; Development; Disease; Ebola; Emergency Situation; Epidemic; Health; Health Benefit; Health system; Hospitals; Human; Immunoglobulin A; Immunoglobulin G; Immunoglobulin M; Infection; Influenza; Influenza A Virus, H1N1 Subtype; Institutional Review Boards; Intubation; Letters; Liquid substance; Long Island; Lung diseases; Measles; Mediating; Medical center; Medicine; Meta-Analysis; Microbe; Middle East Respiratory Syndrome; New York; New York City; Outcome; Patients; Persons; Placebos; Plasma; Pneumococcal Pneumonia; Protocols documentation; Public Health; Randomized; Recording of previous events; Reporting; Research; Respiratory Failure; Safety; Saline; Serum; Severe Acute Respiratory Syndrome; Spanish flu; Symptoms; Therapeutic; Toxin; Treatment Efficacy; United States; Universities; Virus; base; blood product; college; comparative efficacy; design; effective therapy; experience; falls; improved; influenza pneumonia; mortality; mortality risk; pandemic disease; pandemic influenza; phase 2 study; phase II trial; placebo controlled trial; respiratory; symptomatic improvement; trial comparing; trial design

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.

摘要 对于COVID-19，没有任何科学证明或批准的疗法。恢复期血浆（CP）， 是从COVID-19康复者身上获得的血浆，含有SARS-CoV抗体， 2、导致这种疾病的病毒。CP在改善症状和死亡率方面有着悠久的历史 其他流行性疾病，如1918年和2009年的流感和SARS，以及无数其他毒素， 介导的和传染性疾病。因此，CP是一种合理的、容易获得的治疗选择， 2019冠状病毒病。纽约市地区有数千名从COVID-19中康复的人， 捐献了他们的血浆来帮助其他患有这种疾病的人。该项目是一个合作 一项随机盲法安慰剂对照试验，评价CP治疗住院患者的疗效 与COVID-19，正在进行的三个纽约（NYU）Langone健康医院， 曼哈顿、布鲁克林和长岛、贝尔维尤医院中心和三个蒙蒂菲奥里医疗中心（MMC） 布朗克斯的医院。我们设计并启动了这项试验，因为纽约市的大流行迅速发展， Einstein-Montefiore建立的区域合作开展的多中心、把握度良好的2期试验， 在纽约血液中心（NYBC）的支持下，NYU-Langone CTSA。支撑这一假设的是 与安慰剂相比，CP的施用将避免呼吸恶化，这是死亡的主要原因 在COVID-19患者中。本项目的具体目标是：1）研究CP是否降低了 与安慰剂相比，因COVID-19住院的患者呼吸恶化的可能性（盐水溶液， SS）给药后14天，以及2）确定SARS定量和定性之间的关联- 接受CP和安慰剂治疗的COVID-19住院患者的CoV-2抗体水平和临床结局。 证明CP对COVID-19有效的公共卫生益处，COVID-19已导致338，000例感染 美国有21,845人死亡，纽约市有187,250人感染，1,127人死亡， 巨大的公共卫生进步，可以挽救成千上万的生命。