Milam Ashlee N, Doan Diana T, Childress Darrell T, Durham Spencer H
Harrison School of Pharmacy, Auburn University, Auburn, AL, USA.
East Alabama Medical Center, Opelika, AL, USA.
J Pharm Technol. 2022 Jun;38(3):169-173. doi: 10.1177/87551225221080027. Epub 2022 Mar 4.
The coronavirus disease 2019 (COVID-19) is a novel coronavirus that has caused an unprecedented global pandemic, with few treatment options currently available. Neutralizing monoclonal antibodies (mAbs) are a promising treatment approach to reduce hospitalizations in high-risk patients with mild-to-moderate COVID-19 infections.
The primary objective is to compare hospitalization rates of high-risk patients who tested positive for COVID-19 within 28 days between those who received mAb infusions versus those who did not. Secondary objectives were emergency department (ED) visits and mortality within 28 days of a positive test.
This single-center, institutional review board-approved, retrospective, observational cohort study included patients aged 19 years and older who tested positive for COVID-19 between December 2, 2020 and February 28, 2021. Patients who received the mAbs bamlanivimab or casirivimab/imdevimab were compared with patients who did not receive mAb infusions to examine hospitalization rates, ED visits, and mortality within 28 days of the positive COVID-19 test.
A total of 2780 patients were evaluated for inclusion using electronic chart review via Cerner. Of the 1612 patients who met inclusion criteria, 568 received an mAb infusion (mAb group) and 1044 did not (non-mAb group). Baseline characteristics were similar between the 2 groups. Of the patients in the mAb group, 34 (6%) were hospitalized versus 397 (38%) in the non-mAb group. Patients with ED visits included 111 (20%) and 672 (64%) in the mAb and non-mAb groups, respectively. Finally, 5 patients in the mAb group experienced mortality (0.9%) versus 83 (8%) in the non-mAb group. Each endpoint achieved statistical significance with a value of <0.0001.
Monoclonal antibody infusions are effective in preventing hospitalization, ED visits, and mortality in high-risk patients with mild-to-moderate COVID-19.
2019年冠状病毒病(COVID-19)是一种新型冠状病毒,已引发了一场前所未有的全球大流行,目前几乎没有可用的治疗选择。中和单克隆抗体(mAbs)是一种有前景的治疗方法,可降低轻度至中度COVID-19感染的高危患者的住院率。
主要目的是比较在28天内COVID-19检测呈阳性的高危患者中,接受mAb输注的患者与未接受mAb输注的患者的住院率。次要目的是检测呈阳性后28天内的急诊科(ED)就诊情况和死亡率。
这项单中心、经机构审查委员会批准的回顾性观察队列研究纳入了2020年12月2日至2021年2月28日期间COVID-19检测呈阳性的19岁及以上患者。将接受mAbs巴瑞替尼单抗或卡西瑞韦单抗/依德维单抗的患者与未接受mAb输注的患者进行比较,以检查COVID-19检测呈阳性后28天内的住院率、ED就诊情况和死亡率。
通过Cerner电子病历审查共评估了2780例患者是否符合纳入标准。在1612例符合纳入标准的患者中,568例接受了mAb输注(mAb组),1044例未接受(非mAb组)。两组的基线特征相似。mAb组中有34例(6%)住院,而非mAb组中有397例(38%)住院。mAb组和非mAb组的ED就诊患者分别为111例(20%)和672例(64%)。最后,mAb组中有5例患者死亡(0.9%),而非mAb组中有83例(8%)。每个终点均达到统计学显著性,P值<0.0001。
单克隆抗体输注可有效预防轻度至中度COVID-19高危患者的住院、ED就诊和死亡。