Background Patients with immunodeficiency-associated antibody disorders are at a higher risk of prolonged/persistent COVID-19 infection, having no viable treatment options. Methods A retrospective analysis of patients with primary and/or secondary immunodeficiency-associated antibody disorders who received casirivimab and imdevimab (REGEN-COV®) under emergency compassionate use. Objective were to describe safety and response to REGEN-COV, focusing on the subset of patients who had COVID-19 duration ≥21 days before treatment. Results Quantitative (change in oxygenation status and/or viral load) and/or qualitative (physician-reported clinical status) outcomes data are reported from 64 patients. Improvement in ≥1 outcome was observed in 90.6% of the overall patient group. Thirty-seven of these had COVID-19 duration ≥21 days before treatment; median time from diagnosis to REGEN-COV treatment was 60.5 days. Of the 29 patients with COVID-19 duration ≥21 days before treatment and available outcome data, 96.6% showed improvement in ≥1 outcome. In the 14 patients with post-treatment reverse transcription–polymerase chain reaction (RT-PCR) results available, 11 (78.6%) reported a negative RT-PCR following treatment, with 5 (45.5%) and 8 (72.7%) patients reporting a negative RT-PCR within 5 days and 21 days of treatment, respectively. Ten of 85 patients (11.8%) experienced serious adverse events; only one was an infusion-related reaction, possibly related to REGEN-COV. Two deaths were reported; neither were attributed to REGEN-COV. Conclusions In this retrospective analysis of immunodeficient patients granted REGEN-COV under emergency compassionate use, REGEN-COV treatment was associated with rapid viral clearance and clinical improvement in patients with longstanding COVID-19. Adverse events were consistent with COVID-19 and its associated complications, and due to patients’ concurrent medical conditions.

中文翻译：

---

在 2019 年冠状病毒病 (COVID-19) 和免疫缺陷相关抗体疾病患者中同情使用 REGEN-COV®

背景 患有免疫缺陷相关抗体疾病的患者长期/持续感染 COVID-19 的风险更高，没有可行的治疗选择。方法回顾性分析在紧急同情使用下接受卡西利单抗和伊姆德单抗 (REGEN-COV®) 的原发性和/或继发性免疫缺陷相关抗体疾病患者。目的是描述对 REGEN-COV 的安全性和反应，重点是治疗前 COVID-19 持续时间≥21 天的患者子集。结果 64 名患者报告了定量（氧合状态和/或病毒载量的变化）和/或定性（医生报告的临床状态）结果数据。在整个患者组的 90.6% 中观察到 ≥1 个结果的改善。其中 37 人在治疗前 COVID-19 持续时间≥21 天；从诊断到 REGEN-COV 治疗的中位时间为 60.5 天。在治疗前 COVID-19 病程≥21 天且有可用结果数据的 29 名患者中，96.6% 的患者≥1 项结果有所改善。在获得治疗后逆转录聚合酶链反应 (RT-PCR) 结果的 14 例患者中，11 例 (78.6%) 报告治疗后 RT-PCR 阴性，其中 5 例 (45.5%) 和 8 例 (72.7%) 患者报告分别在治疗后 5 天和 21 天内 RT-PCR 阴性。85 名患者中有 10 名（11.8%）出现了严重的不良事件；只有一个是输液相关反应，可能与 REGEN-COV 有关。据报道有两人死亡；两者都没有归因于 REGEN-COV。结论 在这项对在紧急同情使用下授予 REGEN-COV 的免疫缺陷患者的回顾性分析中，REGEN-COV 治疗与长期 COVID-19 患者的快速病毒清除和临床改善有关。不良事件与 COVID-19 及其相关并发症一致，并且是由于患者同时存在的医疗状况。