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一项随机临床试验

原文发布日期：2022-12-29

英文摘要：

摘要翻译：

原文链接：

文章：

一项随机临床试验

a randomized clinical trial

原文发布日期：2022-12-29

英文摘要：

Patients with cancer are at high risk of severe coronavirus disease 2019 (COVID-19), with high morbidity and mortality. Furthermore, impaired humoral response renders severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines less effective and treatment options are scarce. Randomized trials using convalescent plasma are missing for high-risk patients. Here, we performed a randomized, open-label, multicenter trial (https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001632-10/DE) in hospitalized patients with severe COVID-19 (n = 134) within four risk groups ((1) cancer (n = 56); (2) immunosuppression (n = 16); (3) laboratory-based risk factors (n = 36); and (4) advanced age (n = 26)) randomized to standard of care (control arm) or standard of care plus convalescent/vaccinated anti-SARS-CoV-2 plasma (plasma arm). No serious adverse events were observed related to the plasma treatment. Clinical improvement as the primary outcome was assessed using a seven-point ordinal scale. Secondary outcomes were time to discharge and overall survival. For the four groups combined, those receiving plasma did not improve clinically compared with those in the control arm (hazard ratio (HR) = 1.29; P = 0.205). However, patients with cancer experienced a shortened median time to improvement (HR = 2.50; P = 0.003) and superior survival with plasma treatment versus the control arm (HR = 0.28; P = 0.042). Neutralizing antibody activity increased in the plasma cohort but not in the control cohort of patients with cancer (P = 0.001). Taken together, convalescent/vaccinated plasma may improve COVID-19 outcomes in patients with cancer who are unable to intrinsically generate an adequate immune response.

摘要翻译：

患有癌症的患者感染严重冠状病毒病2019（COVID-19）的风险很高，病情和死亡率都很重。此外，由于免疫应答受损，现有SARS-CoV-2疫苗的效果也受到限制，治疗选择也很有限。针对高风险患者的随机试验缺失。为此，我们进行了一个多中心、随机、开放标签的临床试验（https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001632-10/DE），招募了134名住院 severe COVID-19 病人，分为四个风险组： (1) 癌症患者（n=56）；(2) 免疫抑制者（n=16）；(3) 基于实验室的风险因素（n=36）；和(4) 高龄者（n=26）。受试者随机分配到常规治疗组或常规治疗加康复血浆或新冠疫苗中和的抗体（ plasma arm ）。在 plasma 处理相关事件中没有观察到严重不良事件。临床改善作为主要结果，使用七点有序尺度进行评估。次要结果是出院时间和总生存率。将四个组结合起来分析，接受 plasma治疗的患者与常规组相比，在临床改善方面没有显著差异（HR=1.29；P=0.205）。然而，癌症患者在改善时间上有明显缩短（HR=2.50；P=0.003），且在 plasma治疗下总生存率优于常规组（HR=0.28；P=0.042）。康复血浆中的中和抗体活性增加，但对癌症患者的免疫抑制者而言，在常规治疗组中没有增加（P=0.001）。总体来说，可能康复/新冠疫苗血浆可以改善无法内在产生足够免疫力的癌症患者 COVID-19 的结果。