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

项目总结 拟议的迈阿密临床和转化科学研究所(CTSI)的行政补充是 评价恢复期血浆治疗效果的随机、盲法、安慰剂对照试验 (CP)新冠肺炎住院患者。研究表明，在新冠肺炎中输注CP是安全的 病人。然而，这项试验的目的是获得科学证据，以支持或拒绝以下假设 CP可能是新冠肺炎的一种治疗选择。支持这项试验的假设是，与 安慰剂，给予CP将避免呼吸恶化，这是死亡的主要原因，并改善临床 新冠肺炎患者住院治疗情况分析。这项试验是在几个网站上进行的，这些网站 经历了新冠肺炎案件数量的快速上升，包括佛罗里达州迈阿密、纽约市、 和德克萨斯州的休斯顿。迈阿密是美国新冠肺炎大流行的新震中，也是 全球热点。这项研究是在现有的CTSA奖的范围内，其重点是网络试验 和快速站点启动和团队科学，并利用迈阿密CTSI对动员资源的重点 应对迅速出现的传染病，这在2015年寨卡病毒期间得到了证明。迈阿密将作为一个 新网站在这个快速设计和启动的试验中，在纽约市已经做的工作的基础上开发了一个 通过区域协作和CTSA财团合作，进行多中心、功能强大的第二阶段试验。

PROJECT SUMMARY The proposed administrative supplement to the Miami Clinical and Translational Science Institute (CTSI) is a randomized blinded placebo-controlled trial to evaluate the efficacy of treatment with convalescent plasma (CP) in hospitalized patients with COVID-19. Studies have shown that CP is safe for transfusion in COVID-19 patients. However, this trial was developed to obtain scientific evidence to support or reject the hypothesis that CP may be a therapeutic option for COVID-19. The hypothesis underpinning this trial is that compared to placebo, administration of CP will avert respiratory deterioration, the main cause of death, and improve clinical status in patients hospitalized with COVID-19. This trial is being conducted across several sites that have experienced rapidly rising numbers of COVID-19 cases, including Miami, Florida, New York City, New York, and Houston Texas. Miami is the new epicenter of the COVID-19 pandemic in the United States, and one of the global hot spots. This study is within the scope of the existing CTSA award, with its focus on network trials and rapid site initiation and team science, and leverages the Miami CTSI’s focus on mobilizing resources in response to rapidly emerging infectious diseases, proven during the Zika virus in 2015. Miami will serve as a new site in this quickly designed and launched trial, building upon the work already done in NYC to develop a multicenter, well-powered Phase 2 trial via regional collaborations and CTSA consortium partnerships.