Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.
ISGlobal, Hospital Clínic, Universitat de Barcelona, Barcelona, Spain.
Nat Commun. 2022 May 11;13(1):2583. doi: 10.1038/s41467-022-29911-3.
Data on convalescent plasma (CP) treatment in COVID-19 outpatients are scarce. We aimed to assess whether CP administered during the first week of symptoms reduced the disease progression or risk of hospitalization of outpatients. Two multicenter, double-blind randomized trials (NCT04621123, NCT04589949) were merged with data pooling starting when <20% of recruitment target was achieved. A Bayesian-adaptive individual patient data meta-analysis was implemented. Outpatients aged ≥50 years and symptomatic for ≤7days were included. The intervention consisted of 200-300mL of CP with a predefined minimum level of antibodies. Primary endpoints were a 5-point disease severity scale and a composite of hospitalization or death by 28 days. Amongst the 797 patients included, 390 received CP and 392 placebo; they had a median age of 58 years, 1 comorbidity, 5 days symptoms and 93% had negative IgG antibody-test. Seventy-four patients were hospitalized, 6 required mechanical ventilation and 3 died. The odds ratio (OR) of CP for improved disease severity scale was 0.936 (credible interval (CI) 0.667-1.311); OR for hospitalization or death was 0.919 (CI 0.592-1.416). CP effect on hospital admission or death was largest in patients with ≤5 days of symptoms (OR 0.658, 95%CI 0.394-1.085). CP did not decrease the time to full symptom resolution.
Clinicaltrials.gov NCT04621123 and NCT04589949.
NCT04621123 and NCT04589949 on https://www.
gov.
评估 COVID-19 门诊患者在症状出现的第一周内接受恢复期血浆（CP）治疗是否会降低疾病进展或住院风险。
对 2 项多中心、双盲随机试验（NCT04621123、NCT04589949）进行合并，在达到 20%的招募目标时开始进行数据汇总和池化。采用贝叶斯自适应个体患者数据荟萃分析。纳入年龄≥50 岁、症状出现≤7 天的门诊患者。干预措施包括给予 200-300ml 具有预定义最低抗体水平的 CP。主要终点是 5 分疾病严重程度量表和 28 天内住院或死亡的复合终点。
在纳入的 797 例患者中，390 例接受 CP 治疗，392 例接受安慰剂治疗；中位年龄 58 岁，合并 1 种疾病，症状持续 5 天，93%患者 IgG 抗体检测为阴性。74 例患者住院，6 例需要机械通气，3 例死亡。CP 改善疾病严重程度量表的比值比（OR）为 0.936（95%可信区间（CI）0.667-1.311）；CP 治疗组住院或死亡的 OR 为 0.919（95%CI 0.592-1.416）。CP 对住院或死亡的影响在症状持续时间≤5 天的患者中最大（OR 0.658，95%CI 0.394-1.085）。CP 并未缩短完全症状缓解的时间。
CP 治疗 COVID-19 门诊患者在症状出现的第一周内不能降低疾病进展或住院风险。
