■恢复期血浆(CP)在大流行的早期成为COVID-19的潜在治疗方法。虽然住院患者的疗效一直不佳,CP在疾病的第一阶段可能是有益的。尽管出现了多个新的变体,没有试验涉及CP变异特异性抗体滴度的分析.
■我们招募了在症状发作后10天内住院的COVID-19患者,采用双盲方法,以1:1:1的比例随机分配给他们接受200ml恢复期血浆,其中针对祖先菌株(武汉样变体)的中和抗体(NAb)滴度高(HCP)或低(LCP)滴度或安慰剂。主要终点包括插管,皮质类固醇治疗症状加重,和安全性评估为严重不良事件。对于预先计划的临时分析,根据输注CP'sNAb滴度与感染受者的变异体,即同源HCP(hHCP)或LCP(hLCP)的滴度,对患者进行重新分组.
■57名患者中,18收到HCP,19个LCP和20个安慰剂,所有小组都比计划的要小。主要终点没有发现显著差异。在临时分析中,HHCPrecipients需要的呼吸支持明显减少,与接受hLCP(9/23;39.1%)或安慰剂(8/20;40%)相比,似乎给予皮质类固醇的频率更低(1/14;7.1%),(p=0.077)。
■我们的双盲,对于早期住院的COVID-19患者,安慰剂对照的CP治疗试验的效力仍然不足,无法得出任何确切的结论。有趣的是,然而,通过同源-接受者\'变体特异性-CP滴度重组建议对hHCP的益处。我们鼓励对正在进行/以前的大型CP研究进行类似的重新分析。
■ClinTrials.gov标识符:NCT0473040。
UNASSIGNED: Convalescent plasma (CP) emerged as potential treatment for COVID-19 early in the pandemic. While efficacy in hospitalised patients has been lacklustre, CP may be beneficial at the first stages of disease. Despite multiple new variants emerging, no trials have involved analyses on variant-specific antibody titres of CP.
UNASSIGNED: We recruited hospitalised COVID-19 patients within 10 days of symptom onset and, employing a double-blinded approach, randomised them to receive 200 ml convalescent plasma with high (HCP) or low (LCP) neutralising antibody (NAb) titre against the ancestral strain (Wuhan-like variant) or placebo in 1:1:1 ratio. Primary endpoints comprised intubation, corticosteroids for symptom aggravation, and safety assessed as serious adverse events. For a preplanned ad hoc analysis, the patients were regrouped by infused CP\'s NAb titers to variants infecting the recipients i.e. by titres of homologous HCP (hHCP) or LCP (hLCP).
UNASSIGNED: Of the 57 patients, 18 received HCP, 19 LCP and 20 placebo, all groups smaller than planned. No significant differences were found for primary endpoints. In ad hoc analysis, hHCPrecipients needed significantly less respiratory support, and appeared to be given corticosteroids less frequently (1/14; 7.1%) than those receiving hLCP (9/23; 39.1%) or placebo (8/20; 40%), (p = 0.077).
UNASSIGNED: Our double-blinded, placebo-controlled CP therapy trial remained underpowered and does not allow any firm conclusions for early-stage hospitalised COVID-19 patients. Interestingly, however, regrouping by homologous - recipients\' variant-specific - CP titres suggested benefits for hHCP. We encourage similar re-analysis of ongoing/previous larger CP studies.
UNASSIGNED: ClinTrials.gov identifier: NCT0473040.