Wright-Patterson Medical Center, Wright-Patterson AFB, OH 45433, USA.
Boonshoft School of Medicine, Wright State University, Fairborn, OH 45324, USA.
Mil Med. 2022 Oct 29;187(11-12):e1261-e1264. doi: 10.1093/milmed/usab188.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease 2019 (COVID-19), was first identified in 2019 in Wuhan, China, and has rapidly spread across the world. As of April 2021, SARS-CoV-2 has infected more than 140,000,000 and caused more than 3,000,000 deaths globally. In November 2020, the monoclonal antibody bamlanivimab was approved by the FDA for non-hospitalized patients with SARS-CoV-2 (COVID-19) who possessed risk factors for progression to severe COVID-19. This provided a treatment option that may help prevent hospitalization.
Patients who regularly received ambulatory care at a military treatment facility and who were diagnosed with mild-to-moderate COVID-19 and possessed risk factors for progression to severe COVID-19 were treated with a single, intravenous infusion (700 mg) of the virus-neutralizing monoclonal antibody bamlanivimab. The primary outcome was improvement of self-reported symptoms within 24 to 72 hours of receiving the infusion. The secondary outcome was prevention of disease progression requiring emergency department (ED) utilization or hospitalization related to COVID-19 within 30 days of infusion. Bamlanivimab was administered in accordance with the FDA's approval and Defense Health Agency's guidance, including follow-up within 72 hours of administration. Institutional Review Board (IRB) approval was obtained.
Of the COVID-19 patients who were given the option of a bamlanivimab infusion, 40 accepted and 6 did not (40/46, 86.9%). Thirty-six of 40 patients in the treatment group were contacted within 72 hours. ED/hospitalization information was available for all 46 patients. In the treatment group, 94.4% (34/36) reported global improvement. Three of 40 (7.5%) patients in the treatment group required inpatient admission, and 2 of 40 patients (5%) required ED evaluation within 30 days of infusion. Therefore, 5 of 40 (12.5%) patients required evaluation shortly after infusion, while 2 of 6 (33.3%) patients who declined treatment required hospital evaluation or admission related to COVID-19 within 30 days of infusion (P = .15).
Global improvement of symptoms within 24 to 72 hours of infusion was reported by 94.4% of patients receiving bamlanivimab; however, statistical significance could not be determined due to the small sample size and lack of placebo group due to study design. Furthermore, ED visits and hospital admissions were analyzed, but with only six patients in the comparison group, the relative risk was not statistically significant and could not be precisely estimated. In the future, this study can be replicated with both larger control/treatment arms to validate the initial results of this small, retrospective, cohort study.
严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）是导致 2019 年冠状病毒病（COVID-19）的病原体，于 2019 年在中国武汉首次被发现，并迅速在全球范围内传播。截至 2021 年 4 月，SARS-CoV-2 已感染超过 1.4 亿人，全球死亡超过 300 万人。2020 年 11 月，FDA 批准了单克隆抗体 bamlanivimab 用于非住院 COVID-19（SARS-CoV-2）患者，这些患者具有向重症 COVID-19 进展的风险因素。这提供了一种可能有助于预防住院的治疗选择。
在军事治疗机构接受常规门诊护理、被诊断为轻度至中度 COVID-19 且具有向重症 COVID-19 进展风险因素的患者接受单次静脉输注（700mg）病毒中和单克隆抗体 bamlanivimab。主要结局是在接受输注后 24 至 72 小时内自我报告症状的改善。次要结局是在输注后 30 天内需要因 COVID-19 而紧急部门（ED）就诊或住院治疗的疾病进展的预防。bamlanivimab 的使用符合 FDA 的批准和国防卫生局的指南，包括给药后 72 小时内的随访。获得了机构审查委员会（IRB）的批准。
在接受 bamlanivimab 输注选择的 COVID-19 患者中，40 人接受了治疗，6 人拒绝了治疗（40/46，86.9%）。治疗组的 40 名患者中有 36 名在 72 小时内得到了联系。所有 46 名患者的 ED/住院信息均可获得。在治疗组中，94.4%（34/36）的患者报告了全身改善。治疗组中有 3 例（7.5%）患者需要住院治疗，有 2 例（5%）患者需要在输注后 30 天内进行 ED 评估。因此，5 例（12.5%）患者在输注后不久需要评估，而 6 例（33.3%）拒绝治疗的患者中有 2 例在输注后 30 天内因 COVID-19 需要住院评估或入院（P=0.15）。
接受 bamlanivimab 治疗的患者在输注后 24 至 72 小时内报告症状总体改善的比例为 94.4%；然而，由于样本量小且由于研究设计缺乏安慰剂组，无法确定统计学意义。此外，还分析了 ED 就诊和住院治疗情况，但由于比较组只有 6 名患者，相对风险没有统计学意义，也无法精确估计。在未来，可以对更大的对照组/治疗组进行复制，以验证这项小型回顾性队列研究的初步结果。
