A Feasibility Study Assessing the Safety of Multiple Doses of Anti-SARS-CoV-2 Plasma in Mechanically Ventilated Intubated Patients With Respiratory Failure Due to COVID-19

This study will assess the feasibility of administering multiple doses of convalescent plasma (from people who have recovered form SARS-CoV-2) to Covid-19 positive patients in the Intensive Care Unit receiving mechanical ventilation. Donor plasma will not be obtained under this protocol, but all plasma used will follow FDA guidelines for Investigational COVID-19 Convalescent Plasma use. Patients may receive single or double plasma units infused on days 0, 3, and 6. This decision may be based on availability of blood plasma. The primary objective of this study is feasibility. Feasibility will be assessed based on the proportion of subjects who consent and receive at least one dose of convalescent plasma. The study will be declared 'feasible' if at least 80% of subjects who consent receive at least one dose. The secondary study endpoint is overall survival at day 60 after first dose of convalescent plasma. Respiratory status and overall clinical status will be reviewed during follow up on days 14, 28, and 60.本研究旨在评估为接受有创机械通气的重症监护病房（Intensive Care Unit，ICU）新型冠状病毒肺炎（COVID-19）阳性患者输注多剂恢复期血浆（convalescent plasma，来源于曾感染严重急性呼吸综合征冠状病毒2（SARS-CoV-2）并康复的供者）的可行性。本研究方案无需采集供者血浆，所有使用的血浆均将遵循美国食品药品监督管理局（Food and Drug Administration，FDA）发布的《研究用新型冠状病毒肺炎恢复期血浆使用指南》。受试者可在第0、3、6日接受单份或双份血浆输注，具体输注剂量可根据血浆供应情况调整。本研究的主要终点为可行性：可行性将通过签署知情同意并接受至少一剂恢复期血浆的受试者占比进行评估。若签署知情同意的受试者中至少80%接受了至少一剂恢复期血浆，则判定本研究“可行”。次要研究终点为接受首剂恢复期血浆后第60天的总生存率。随访阶段将在第14、28、60天对受试者的呼吸状态与整体临床状态进行评估。