From the Department of Medicine, Division of Infectious Diseases (K.A.G., S.S.), the Department of Pathology (E.M.B., C.E.M., A.A.R.T.), the Department of Neurology, Brain Injury Outcomes Division (A.Y., K.L., N.A.M., A.L.G., N.K., D.F.H.), the Department of Ophthalmology (D.A.J.), the Welch Center for Prevention, Epidemiology and Clinical Research (L.J.A.), and the Institute for Clinical and Translational Research (D.E.F.), Johns Hopkins School of Medicine, and the Departments of Molecular Microbiology and Immunology (D.J.S., A.S., A.P., S.L.K., A.C.), International Health (L.L.H., C.G.S.), and Epidemiology (B.L., D.M.S., S.E., S.N.B.), Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, the Division of Intramural Research, National Institute of Allergy and Infectious Diseases, Bethesda (O.L.), and Luminis Health, Annapolis (B.R.M.) - all in Maryland; the Department of Medicine, Division of Hematology and Oncology, MedStar Washington Hospital Center (A.G.S.), and the Department of Medicine, Division of Infectious Diseases, Georgetown University Medical Center (S.G.K.) - both in Washington, DC; the Division of Allergy and Immunology, Department of Medicine (G.S.M.), and the Department of Pathology (T.J.G.), NorthShore University Health System, Evanston, IL; the Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine (Y.F.), the Department of Medicine, Division of Pulmonary and Critical Care Medicine, University of Texas Health Science Center (B.P.), Houston, and The Next Practices Group, Austin (E.C.F.) - all in Texas; the Department of Medicine, Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham (S.L.H.); the Department of Emergency Medicine, Rhode Island Hospital, Brown University, Providence, RI (A.C.L.); the Department of Medicine, Division of Infectious Diseases, University of Utah School of Medicine, Salt Lake City (E.S.S.); the Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami (S.A.); the Department of Medicine, Division of Infectious Diseases, University of Cincinnati, Cincinnati (M.A.H.); the Department of Medicine, Division of Infectious Diseases, Mayo Clinic Hospital, Phoenix, AZ (J.E.B.); the Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles (J.S.C.), Ascada Research (K.O., M.A.), the Department of Medicine, Division of Infectious Diseases, University of California, Irvine (D.N.F.), and the Department of Medicine, Division of Infectious Diseases, University of California, San Diego (E.R.C.) - all in California; the Department of Emergency Medicine, Wayne State University, Detroit (J.H.P.); the Department of Medicine, Division of Hematology and Oncology, University of Massachusetts Chan Medical School, Worcester (J.M.G.); Nuvance Health (J.R.P., W.R., M.-E.C.), and Nuvance Health Danbury Hospital (P.B.B.), Danbury, and Nuvance Health Norwalk Hospital, Norwalk (J.H., B.G.) - all in Connecticut; Nuvance Health Vassar Brothers Medical Center, Poughkeepsie (V.C.C., D.C.), the Department of Medicine, University of Rochester Medical Center, Rochester (M.S.Z.), and the Bliss Group, New York (M.R.) - all in New York; and the Department of Pathology, University of New Mexico School of Medicine, Albuquerque, NM (J.S.R.).
N Engl J Med. 2022 May 5;386(18):1700-1711. doi: 10.1056/NEJMoa2119657. Epub 2022 Mar 30.
BACKGROUND: Polyclonal convalescent plasma may be obtained from donors who have recovered from coronavirus disease 2019 (Covid-19). The efficacy of this plasma in preventing serious complications in outpatients with recent-onset Covid-19 is uncertain. METHODS: In this multicenter, double-blind, randomized, controlled trial, we evaluated the efficacy and safety of Covid-19 convalescent plasma, as compared with control plasma, in symptomatic adults (≥18 years of age) who had tested positive for severe acute respiratory syndrome coronavirus 2, regardless of their risk factors for disease progression or vaccination status. Participants were enrolled within 8 days after symptom onset and received a transfusion within 1 day after randomization. The primary outcome was Covid-19-related hospitalization within 28 days after transfusion. RESULTS: Participants were enrolled from June 3, 2020, through October 1, 2021. A total of 1225 participants underwent randomization, and 1181 received a transfusion. In the prespecified modified intention-to-treat analysis that included only participants who received a transfusion, the primary outcome occurred in 17 of 592 participants (2.9%) who received convalescent plasma and 37 of 589 participants (6.3%) who received control plasma (absolute risk reduction, 3.4 percentage points; 95% confidence interval, 1.0 to 5.8; P = 0.005), which corresponded to a relative risk reduction of 54%. Evidence of efficacy in vaccinated participants cannot be inferred from these data because 53 of the 54 participants with Covid-19 who were hospitalized were unvaccinated and 1 participant was partially vaccinated. A total of 16 grade 3 or 4 adverse events (7 in the convalescent-plasma group and 9 in the control-plasma group) occurred in participants who were not hospitalized. CONCLUSIONS: In participants with Covid-19, most of whom were unvaccinated, the administration of convalescent plasma within 9 days after the onset of symptoms reduced the risk of disease progression leading to hospitalization. (Funded by the Department of Defense and others; CSSC-004 ClinicalTrials.gov number, NCT04373460.).
背景：多克隆恢复期血浆可从已从 COVID-19 中康复的供者中获得。该血浆用于预防近期发病的 COVID-19 门诊患者发生严重并发症的疗效尚不确定。
方法：在这项多中心、双盲、随机、对照试验中，我们评估了 COVID-19 恢复期血浆与对照血浆相比，在症状出现后 8 天内接受治疗且无论疾病进展的危险因素或疫苗接种状态如何均为 SARS-CoV-2 检测呈阳性的成年（≥18 岁）患者中的疗效和安全性。参与者在症状出现后 1 天内随机分组后接受输血。主要结局为输血后 28 天内 COVID-19 相关住院。
结果：参与者于 2020 年 6 月 3 日至 2021 年 10 月 1 日入组。共有 1225 名参与者接受随机分组，1181 名接受输血。在仅包括接受输血的参与者的预先指定的改良意向治疗分析中，主要结局发生在 592 名接受恢复期血浆的参与者中的 17 名（2.9%）和 589 名接受对照血浆的参与者中的 37 名（6.3%）（绝对风险降低 3.4 个百分点；95%置信区间 1.0 至 5.8；P=0.005），这对应于 54%的相对风险降低。由于住院的 COVID-19 患者中有 53 名未接种疫苗，1 名部分接种疫苗，因此这些数据无法推断疫苗接种参与者的疗效证据。在未住院的参与者中，共有 16 例 3 级或 4 级不良事件（恢复期血浆组 7 例，对照组 9 例）。
结论：在 COVID-19 患者中，大多数未接种疫苗的患者在症状出现后 9 天内给予恢复期血浆可降低导致住院的疾病进展风险。（由国防部和其他机构资助；CSSC-004 ClinicalTrials.gov 编号，NCT04373460。）
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