Grubovic Rastvorceva Rada M, Useini Sedula, Stevanovic Milena, Demiri Ilir, Petkovic Elena, Franchini Massimo, Focosi Daniele
Institute for Transfusion Medicine of RNM, 1000 Skopje, North Macedonia.
Faculty of Medical Sciences, University Goce Delcev, 2000 Stip, North Macedonia.
Life (Basel). 2022 Oct 9;12(10):1565. doi: 10.3390/life12101565.
Background: COVID-19 convalescent plasma (CCP) is an important antiviral option for selected patients with COVID-19. Materials and Methods: In this open-label, phase 2, clinical trial conducted from 30 April 2020 till 10 May 2021 in the Republic of North Macedonia, we evaluated the efficacy and safety of CCP in hospitalized patients. Treatment was with a single unit of CCP having an anti-RBD IgG concentration higher than 5 AU/mL. Results: There were 189 patients that completed the study, of which 65 (34.4%) had WHO 8-point clinical progression scale score of 3 (requiring hospital care but not oxygen support), 65 (34.4%) had a score of 4 (hospitalized and requiring supplemental oxygen by mask or nasal prongs), and 59 (31.2%) had a score of 5 (hospitalized and requiring supplemental oxygen by non-invasive ventilation or high-flow oxygen). Mean age was 57 years (range 22−94), 78.5% were males, 80.4% had elevated body mass index, and 70.9% had comorbidity. Following CCP transfusion, we observed clinical improvement with increase rates in oxygenation-free days of 32.3% and 58.5% at 24 h and seven days after CCP transfusion, a decline in WHO scores, and reduced progression to severe disease (only one patient was admitted to ICU after CCP transfusion). Mortality in the entire cohort was 11.6% (22/189). We recorded 0% mortality in WHO score 3 (0/65) and in patients that received CCP transfusion in the first seven days of disease, 4.6% mortality in WHO score 4 (3/65), and 30.5% mortality in WHO score 5 (18/59). Mortality correlated with WHO score (Chi-square 19.3, p < 0.001) and with stay in the ICU (Chi-square 55.526, p ≤ 0.001). No severe adverse events were reported. Conclusions: This study showed that early administration of CCP to patients with moderate disease was a safe and potentially effective treatment for hospitalized COVID-19 patients. The trial was registered at clinicaltrials.gov (NCT04397523).
新冠康复者血浆（CCP）是部分新冠患者重要的抗病毒治疗选择。材料与方法：在2020年4月30日至2021年5月10日于北马其顿共和国开展的这项开放标签的2期临床试验中，我们评估了CCP在住院患者中的疗效和安全性。治疗采用单单位抗RBD IgG浓度高于5 AU/mL的CCP。结果：189例患者完成了研究，其中65例（34.4%）世界卫生组织8分临床进展量表评分为3分（需要住院治疗但无需氧疗支持），65例（34.4%）评分为4分（住院且需通过面罩或鼻导管吸氧），59例（31.2%）评分为5分（住院且需通过无创通气或高流量吸氧）。平均年龄为57岁（范围22 - 94岁），78.5%为男性，80.4%体重指数升高，70.9%有合并症。输注CCP后，我们观察到临床症状改善，CCP输注后24小时和7天时无氧天数增加率分别为32.3%和58.5%，世界卫生组织评分下降，进展为重症的情况减少（CCP输注后仅1例患者入住重症监护病房）。整个队列的死亡率为11.6%（22/189）。我们记录到世界卫生组织评分为3分的患者死亡率为0%（0/65），疾病发病后前7天接受CCP输注的患者死亡率为0%，世界卫生组织评分为4分的患者死亡率为4.6%（3/65），世界卫生组织评分为5分的患者死亡率为30.5%（18/59）。死亡率与世界卫生组织评分相关（卡方检验19.3，p < 0.001），与在重症监护病房的停留时间相关（卡方检验55.526，p ≤ 0.001）。未报告严重不良事件。结论：本研究表明，对中度疾病患者早期给予CCP是住院新冠患者安全且可能有效的治疗方法。该试验已在clinicaltrials.gov注册（NCT04397523）。
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