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COVID-19 恢复期血浆治疗儿童 SARS-CoV-2 感染中重度病例的安全性和抗体动力学。

Safety and Antibody Kinetics of COVID-19 Convalescent Plasma for the Treatment of Moderate to Severe Cases of SARS-CoV-2 Infection in Pediatric Patients.

机构信息

From the CHOC Children's Hospital, Division of Infectious Diseases, Orange, California.

Department of Pediatrics, University of California, Irvine, California.

出版信息

Pediatr Infect Dis J. 2021 Jul 1;40(7):606-611. doi: 10.1097/INF.0000000000003166.

DOI:10.1097/INF.0000000000003166
PMID:33967228
Abstract

BACKGROUND

Therapies against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and its life-threatening respiratory infection coronavirus disease 2019 (COVID-19) have been evaluated, including COVID-19 convalescent plasma (CCP). Multiple large reports of CCP treatment in adults exist. Pediatric data on CCP safety and efficacy are limited.

METHODS

Single-center prospective, open-label trial looking at safety, antibody kinetics and outcomes of CCP (10 mL/kg, max 1 unit) treatment for COVID-19 in hospitalized pediatric patients with moderate to severe disease or at high-risk for serious illness.

RESULTS

Thirteen patients were enrolled. No infusion-related adverse events occurred. No hematologic or metabolic adverse events were noted during hospitalization or at 3-weeks. Ten patients had clinical improvement by day 7 (WHO eight-category ordinal severity scale for COVID-19). Following CCP, anti-SARS-CoV-2 anti-nucleocapsid IgG increased significantly at 24 hours and high levels were sustained at 7- and 21-days. Transient IgM response was noted. Twelve patients (92.3%) were discharged home, 9 (75%) by day 7 post-CCP. One remained on invasive ventilatory support 42 days after CCP and was eventually discharged to an intermediate care facility. The single patient death was retrospectively confirmed to have had brain death before CCP.

CONCLUSION

CCP was well tolerated in pediatric patients, resulted in rapid antibody increase, and did not appear to interfere with immune responses measured at 21 days. More pediatric data are necessary to establish the efficacy of CCP, but our data suggest benefit in moderate to severe COVID-19 when used early. Other immunologic or antiviral interventions may be added as supported by emerging data.

摘要

背景

针对严重急性呼吸综合征冠状病毒 2(SARS-CoV-2)及其危及生命的呼吸道感染 2019 年冠状病毒病(COVID-19)的疗法已得到评估,包括 COVID-19 恢复期血浆(CCP)。有多项关于成人 CCP 治疗的大型报告。关于 CCP 在儿科患者中的安全性和疗效的数据有限。

方法

这是一项单中心前瞻性、开放标签试验,旨在观察 COVID-19 住院儿科患者中 CCP(10ml/kg,最大 1 单位)治疗的安全性、抗体动力学和结局,这些患者患有中度至重度疾病或有发生严重疾病的高风险。

结果

共纳入 13 例患者。无输液相关不良事件发生。在住院期间或 3 周时,未观察到血液学或代谢不良事件。10 例患者在第 7 天(COVID-19 的世界卫生组织八分类严重程度量表)达到临床改善。接受 CCP 后,抗 SARS-CoV-2 抗核衣壳 IgG 在 24 小时内显著增加,7 天和 21 天时仍保持高水平。一过性 IgM 反应。12 例患者(92.3%)出院回家,9 例(75%)在接受 CCP 后第 7 天出院。1 例患者在接受 CCP 后 42 天仍需接受有创通气支持,最终被送往中级护理机构。唯一的患者死亡被回顾性确认为在接受 CCP 前已发生脑死亡。

结论

CCP 在儿科患者中耐受良好,导致快速抗体增加,并且似乎不会干扰在 21 天测量的免疫反应。需要更多的儿科数据来确定 CCP 的疗效,但我们的数据表明,在早期使用时,CCP 对中重度 COVID-19 有效。其他免疫或抗病毒干预措施可能会根据新出现的数据进行添加。

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