早期恢复期血浆治疗 COVID-19 高风险门诊患者。
Early Convalescent Plasma for High-Risk Outpatients with Covid-19.
机构信息
From the University of Michigan, Ann Arbor (F.K.K., R.D.D., C.V.H., V.L.W.S., C.F.G., N.L.H., R.S., W.B.), Spectrum Health, Grand Rapids (J.C.R.), and Michigan State University, East Lansing (J.C.R.) - all in Michigan; the Medical University of South Carolina, Charleston (V.D.-M., S.D.Y., L.D.F., E.L.); Stanford University, Palo Alto, CA (K.S., J.M.H., S.J., J.Q.); Vitalant Research Institute, Scottsdale, AZ (L.J.D.); the National Heart, Lung, and Blood Institute, Bethesda, MD (N.E.K.); the University of Pittsburgh, Pittsburgh (A.K., J.F.M., D.J.T., C.W.C.); Harbor-UCLA Medical Center, Los Angeles (K.Y.); Cooper University Hospital, Camden, NJ (C.W.J.); Oregon Health and Science University, Portland (B.K.); Health Partners Methodist Hospital, St. Louis Park, MN (A.B.); and the University of Chicago, Chicago (D.G.B.).
出版信息
N Engl J Med. 2021 Nov 18;385(21):1951-1960. doi: 10.1056/NEJMoa2103784. Epub 2021 Aug 18.
BACKGROUND
Early administration of convalescent plasma obtained from blood donors who have recovered from coronavirus disease 2019 (Covid-19) may prevent disease progression in acutely ill, high-risk patients with Covid-19.
METHODS
In this randomized, multicenter, single-blind trial, we assigned patients who were being treated in an emergency department for Covid-19 symptoms to receive either one unit of convalescent plasma with a high titer of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or placebo. All the patients were either 50 years of age or older or had one or more risk factors for disease progression. In addition, all the patients presented to the emergency department within 7 days after symptom onset and were in stable condition for outpatient management. The primary outcome was disease progression within 15 days after randomization, which was a composite of hospital admission for any reason, seeking emergency or urgent care, or death without hospitalization. Secondary outcomes included the worst severity of illness on an 8-category ordinal scale, hospital-free days within 30 days after randomization, and death from any cause.
RESULTS
A total of 511 patients were enrolled in the trial (257 in the convalescent-plasma group and 254 in the placebo group). The median age of the patients was 54 years; the median symptom duration was 4 days. In the donor plasma samples, the median titer of SARS-CoV-2 neutralizing antibodies was 1:641. Disease progression occurred in 77 patients (30.0%) in the convalescent-plasma group and in 81 patients (31.9%) in the placebo group (risk difference, 1.9 percentage points; 95% credible interval, -6.0 to 9.8; posterior probability of superiority of convalescent plasma, 0.68). Five patients in the plasma group and 1 patient in the placebo group died. Outcomes regarding worst illness severity and hospital-free days were similar in the two groups.
CONCLUSIONS
The administration of Covid-19 convalescent plasma to high-risk outpatients within 1 week after the onset of symptoms of Covid-19 did not prevent disease progression. (SIREN-C3PO ClinicalTrials.gov number, NCT04355767.).
背景
从已从 COVID-19 中康复的献血者中获取的恢复期血浆的早期给药可能会阻止患有 COVID-19 的急性重病高危患者的疾病进展。
方法
在这项随机、多中心、单盲试验中，我们将在急诊科接受 COVID-19 症状治疗的患者分为接受一剂高滴度针对严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 的抗体的恢复期血浆或安慰剂的组。所有患者年龄均在 50 岁或以上，或有一个或多个疾病进展的危险因素。此外，所有患者在症状发作后 7 天内就诊于急诊科，且病情稳定可门诊管理。主要结局是随机分组后 15 天内的疾病进展，其包括因任何原因住院、寻求急诊或紧急护理或未住院而死亡。次要结局包括 8 级有序量表上的最严重疾病严重程度、随机分组后 30 天内的无住院天数和任何原因导致的死亡。
结果
共有 511 名患者入组（恢复期血浆组 257 名，安慰剂组 254 名）。患者的中位年龄为 54 岁；中位症状持续时间为 4 天。在供者血浆样本中，SARS-CoV-2 中和抗体的中位滴度为 1:641。恢复期血浆组中 77 名（30.0%）患者和安慰剂组中 81 名（31.9%）患者发生疾病进展（风险差，1.9 个百分点；95%可信区间，-6.0 至 9.8；恢复期血浆优势的后验概率，0.68）。血浆组中有 5 名患者和安慰剂组中有 1 名患者死亡。两组间最严重疾病严重程度和无住院天数的结局相似。
结论
在 COVID-19 症状发作后 1 周内对高危门诊患者给予 COVID-19 恢复期血浆并未预防疾病进展。（SIREN-C3PO 临床试验编号，NCT04355767.）
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