Department of Internal Medicine, Section of Infectious Diseases and Department of Medical Microbiology and Infectious Diseases, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.
Department of Internal Medicine, Section of Infectious Diseases and Department of Medical Microbiology and Infectious Diseases, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.
Clin Microbiol Infect. 2023 Feb;29(2):208-214. doi: 10.1016/j.cmi.2022.08.005. Epub 2022 Aug 23.
The potential benefit of convalescent plasma (CP) therapy for coronavirus disease 2019 (COVID-19) is highest when administered early after symptom onset. Our objective was to determine the effectiveness of CP therapy in improving the disease course of COVID-19 among high-risk outpatients.
A multicentre, double-blind randomized trial was conducted comparing 300 mL of CP with non-CP. Patients were ≥50 years, were symptomatic for <8 days, had confirmed RT-PCR or antigen test result for COVID-19 and had at least one risk factor for severe COVID-19. The primary endpoint was the highest score on a 5-point ordinal scale ranging from fully recovered (score = 1) or not (score = 2) on day 7, over hospital admission (score = 3), intensive care unit admission (score = 4) and death (score = 5) in the 28 days following randomization. Secondary endpoints were hospital admission, symptom duration and viral RNA excretion.
After the enrolment of 421 patients and the transfusion in 416 patients, recruitment was discontinued when the countrywide vaccination uptake in those aged >50 years was 80%. Patients had a median age of 60 years, symptoms for 5 days, and 207 of 416 patients received CP therapy. During the 28 day follow-up, 28 patients were hospitalized and two died. The OR for an improved disease severity score with CP was 0.86 (95% credible interval, 0.59-1.22). The OR was 0.58 (95% CI, 0.33-1.02) for patients with ≤5 days of symptoms. The hazard ratio for hospital admission was 0.61 (95% CI, 0.28-1.34). No difference was found in viral RNA excretion or in the duration of symptoms.
In patients with early COVID-19, CP therapy did not improve the 5-point disease severity score.
在症状出现后早期给予恢复期血浆（CP）治疗，对 2019 年冠状病毒病（COVID-19）的潜在益处最大。我们的目的是确定 CP 治疗在改善高危门诊 COVID-19 患者疾病进程方面的有效性。
一项多中心、双盲随机试验比较了 300ml CP 与非 CP。患者年龄≥50 岁，症状出现<8 天，经 RT-PCR 或抗原检测确诊 COVID-19，且至少有一个 COVID-19 重症的危险因素。主要终点是随机分组后 28 天内 5 分制 ordinal 评分中完全恢复（评分=1）或未恢复（评分=2）、住院、入住重症监护病房（评分=4）和死亡（评分=5）的最高评分。次要终点是住院、症状持续时间和病毒 RNA 排出。
在纳入 421 例患者并输注 416 例患者后，当全国 50 岁以上人群疫苗接种率达到 80%时，停止了入组。患者的中位年龄为 60 岁，症状持续 5 天，416 例患者中有 207 例接受 CP 治疗。在 28 天随访期间，28 例患者住院，2 例死亡。CP 治疗改善疾病严重程度评分的 OR 为 0.86（95%可信区间，0.59-1.22）。症状持续时间≤5 天的患者 OR 为 0.58（95%CI，0.33-1.02）。住院的风险比为 0.61（95%CI，0.28-1.34）。病毒 RNA 排出或症状持续时间无差异。
在 COVID-19 早期患者中，CP 治疗并未改善 5 分疾病严重程度评分。
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