PDF(Pubmed)
Abstract：
Although severe coronavirus disease 2019 (COVID-19) and hospitalization associated with COVID-19 are generally preventable among healthy vaccine recipients, patients with immunosuppression have poor immunogenic responses to COVID-19 vaccines and remain at high risk of infection with SARS-CoV-2 and hospitalization. In addition, monoclonal antibody therapy is limited by the emergence of novel SARS-CoV-2 variants that have serially escaped neutralization. In this context, there is interest in understanding the clinical benefit associated with COVID-19 convalescent plasma collected from persons who have been both naturally infected with SARS-CoV-2 and vaccinated against SARS-CoV-2 (\"vax-plasma\"). Thus, we report the clinical outcome of 386 immunocompromised outpatients who were diagnosed with COVID-19 and who received contemporary COVID-19-specific therapeutics (standard-of-care group) and a subgroup who also received concomitant treatment with very high titer COVID-19 convalescent plasma (vax-plasma group) with a specific focus on hospitalization rates. The overall hospitalization rate was 2.2% (5 of 225 patients) in the vax-plasma group and 6.2% (10 of 161 patients) in the standard-of-care group, which corresponded to a relative risk reduction of 65% (P = 0.046). Evidence of efficacy in nonvaccinated patients cannot be inferred from these data because 94% (361 of 386 patients) of patients were vaccinated. In vaccinated patients with immunosuppression and COVID-19, the addition of vax-plasma or very high titer COVID-19 convalescent plasma to COVID-19-specific therapies reduced the risk of disease progression leading to hospitalization.IMPORTANCEAs SARS-CoV-2 evolves, new variants of concern (VOCs) have emerged that evade available anti-spike monoclonal antibodies, particularly among immunosuppressed patients. However, high-titer COVID-19 convalescent plasma continues to be effective against VOCs because of its broad-spectrum immunomodulatory properties. Thus, we report clinical outcomes of 386 immunocompromised outpatients who were treated with COVID-19-specific therapeutics and a subgroup also treated with vaccine-boosted convalescent plasma. We found that the administration of vaccine-boosted convalescent plasma was associated with a significantly decreased incidence of hospitalization among immunocompromised COVID-19 outpatients. Our data add to the contemporary data providing evidence to support the clinical utility of high-titer convalescent plasma as antibody replacement therapy in immunocompromised patients.
摘要：
尽管在健康疫苗接种者中，2019年严重冠状病毒病（COVID-19）和与COVID-19相关的住院通常是可以预防的，免疫抑制患者对COVID-19疫苗的免疫原性反应较差,感染SARS-CoV-2和住院的风险仍然很高.此外,单克隆抗体治疗受到已经连续逃脱中和的新型SARS-CoV-2变体的出现的限制。在这种情况下，有兴趣了解从自然感染SARS-CoV-2和接种SARS-CoV-2疫苗(“vax-plasma”)的人收集的COVID-19恢复期血浆相关的临床益处。因此，我们报告了386例诊断为COVID-19并接受当代COVID-19特异性治疗的免疫功能低下门诊患者(标准治疗组)和一个亚组的临床结局,这些亚组还接受了高滴度COVID-19恢复期血浆的伴随治疗(vax血浆组),特别关注住院率.vax血浆组的总住院率为2.2％（225例患者中的5例），标准治疗组为6.2％（161例患者中的10例），相对风险降低65%(P=0.046)。未接种疫苗的患者的疗效证据不能从这些数据推断，因为94%（386名患者中的361名）的患者接种了疫苗。在接种免疫抑制和COVID-19疫苗的患者中，在COVID-19特异性疗法中添加vax血浆或非常高滴度的COVID-19恢复期血浆可降低疾病进展导致住院的风险。重要的SARS-CoV-2演变，新的关注变种（VOCs）已经出现，逃避可用的抗尖峰单克隆抗体，特别是在免疫抑制患者中。然而,高滴度的COVID-19恢复期血浆由于其广谱免疫调节特性，继续对VOC有效。因此，我们报告了386例接受COVID-19特异性治疗的免疫功能低下门诊患者的临床结局,其中一个亚组也接受了疫苗强化的恢复期血浆治疗.我们发现，在免疫受损的COVID-19门诊患者中，给予疫苗加强的恢复期血浆与住院发生率显着降低相关。我们的数据增加了当代数据，提供了支持高滴度恢复期血浆作为免疫功能低下患者的抗体替代疗法的临床实用性的证据。
