Early Convalescent Plasma for High-Risk Outpatients with Covid-19.
Early Convalescent Plasma for High-Risk Outpatients with Covid-19.
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DOI：
10.1056/nejmoa2103784
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发表时间：
2021-11-18
期刊：
影响因子：
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通讯作者：
SIREN-C3PO Investigators
中科院分区：
文献类型：
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作者：
Korley FK;Durkalski-Mauldin V;Yeatts SD;Schulman K;Davenport RD;Dumont LJ;El Kassar N;Foster LD;Hah JM;Jaiswal S;Kaplan A;Lowell E;McDyer JF;Quinn J;Triulzi DJ;Van Huysen C;Stevenson VLW;Yadav K;Jones CW;Kea B;Burnett A;Reynolds JC;Greineder CF;Haas NL;Beiser DG;Silbergleit R;Barsan W;Callaway CW;SIREN-C3PO Investigators
从2019冠状病毒病（Covid-19）康复的献血者中获得的恢复期血浆的早期给药可能会预防急性高风险Covid-19患者的疾病进展。在这项随机、多中心、单盲试验中，我们将因新冠肺炎症状而在急诊科接受治疗的患者分配为接受一个单位的恢复期血浆（含有高滴度的严重急性呼吸综合征冠状病毒2型（SARS-CoV-2）抗体）或安慰剂。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风险因素。此外，所有患者在症状发作后7天内到急诊科就诊，病情稳定，可接受门诊治疗。主要结局是随机化后15天内的疾病进展，包括因任何原因住院、寻求急诊或紧急护理或未住院死亡。次要结局包括8类有序量表上的疾病最严重程度、随机化后30天内的无住院天数和全因死亡。共有511名患者入组试验（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。在供体血浆样本中，SARS-CoV-2中和抗体的中位滴度为1：641。恢复期血浆组77例患者（30.0%）和安慰剂组81例患者（31.9%）发生疾病进展（风险差异，1.9个百分点; 95%可信区间，-6.0至9.8;恢复期血浆优效性的后验概率，0.68）。血浆组5例患者和安慰剂组1例患者死亡。两组最严重疾病严重程度和无住院天数的结局相似。在新型冠状病毒肺炎症状出现后1周内向高风险门诊患者给予新型冠状病毒肺炎恢复期血浆并不能阻止疾病进展。（SIREN-C3 PO ClinicalTrials.gov编号，NCT 04355767。）
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. 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. 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. 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.)