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.)

中文翻译：

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为 Covid-19 高危门诊患者提供早期恢复期血浆

背景

早期使用从 2019 年冠状病毒病 (Covid-19) 康复的献血者处获得的恢复期血浆可以预防患有 Covid-19 的急性疾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，我们分配因 Covid-19 症状而在急诊室接受治疗的患者接受一个单位的恢复期血浆，其中含有高滴度的抗严重急性呼吸综合征冠状病毒 2（SARS）抗体-CoV-2）或安慰剂。所有患者均为 50 岁或以上，或具有一种或多种疾病进展的危险因素。此外，所有患者均在症状出现后7天内到急诊科就诊，目前病情稳定，接受门诊治疗。主要结局是随机分组后 15 天内的疾病进展，包括因任何原因入院、寻求急诊或紧急护理或未经住院的死亡。次要结局包括按 8 类顺序排列的最严重疾病严重程度、随机分组后 30 天内的无住院天数以及全因死亡。

结果

共有 511 名患者参加了该试验（恢复期血浆组 257 名，安慰剂组 254 名）。患者的中位年龄为 54 岁；症状持续时间中位数为 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。恢复期血浆组有 77 名患者 (30.0%) 发生疾病进展，安慰剂组有 81 名患者 (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；后验优越性概率恢复期血浆，0.68）。血浆组有 5 名患者死亡，安慰剂组有 1 名患者死亡。两组在最严重疾病严重程度和住院天数方面的结果相似。

结论

在出现 Covid-19 症状后 1 周内向高危门诊患者注射 Covid-19 恢复期血浆并不能阻止疾病进展。（SIREN-C3PO ClinicalTrials.gov 编号，NCT04355767。）