患有SARS-CoV-2感染的孕妇患严重疾病的风险增加,包括住院,重症监护入院,通气支持,和死亡。尽管妊娠患者被排除在COVID-19疾病药物治疗的研究试验之外,美国国立卫生研究院的治疗指南指出,不应阻止孕妇接受有效的治疗.casirivimab和imdevimab(REGEN-COV)的输注,单克隆抗体疗法,被证明与安慰剂相比,可以降低与COVID-19相关的住院或任何原因死亡的风险,缓解症状,并更快地降低SARS-CoV-2病毒载量。2021年7月,美国食品和药物管理局发布了REGEN-COV的紧急使用授权。虽然孕妇不包括在最初的试验中,鉴于怀孕人群的发病率和死亡率较高,我们的机构从2021年8月开始向我们的怀孕患者提供REGEN-COV。REGEN-COV给药后的副作用很少见,被认为是COVID-19而不是REGEN-COV的继发副作用。
本研究旨在追踪接受REGEN-COV的未接种疫苗的妊娠患者的安全性和临床结果,并将这些结果与SARS-CoV-2检测呈阳性且符合资格但未接受REGEN-COV的当代患者队列进行比较。我们的假设是怀孕期间服用REGEN-COV是安全的,接受REGEN-COV的孕妇会出现不太严重的COVID-19呼吸道疾病,随着住院时间的减少,重症监护病房的入院率,需要氧气和其他COVID-19疗法。
这是一项回顾性队列研究,对象是SARS-CoV-2检测呈阳性或已知暴露于COVID-19阳性者的孕妇,因此有资格在我们的机构获得REGEN-COV。在这个群体中,我们比较了在2021年3月至10月期间在亚特兰大的格雷迪纪念医院接受REGEN-COV的人和没有接受REGEN-COV的人,格鲁吉亚。研究的主要结局是围产期结局,安全数据,和SARS-CoV-2感染的临床过程。从2021年3月到10月,86名孕妇通过实时聚合酶链反应检测出SARS-CoV-2阳性或已确认暴露。在这个群体中,36人接受REGEN-COV,50人没有。没有输注速率调整或停药的情况,过敏反应,或接受REGEN-COV的个人死亡。一个人在给药后超过24小时出现呼吸急促恶化,这被归类为输液相关反应。围产期结局无显著差异,住院时间,重症监护病房的入院率,两组之间对COVID-19的额外药物治疗或需氧量。
服用REGEN-COV在妊娠期间是安全的,并且不会增加不良产妇,新生儿,或产科结果。在我们的高危人群中,COVID-19相关结局没有统计学上的显著差异。鉴于该药物在怀孕期间可能的安全性及其在非怀孕人群中的已知益处,我们主张继续使用该疗法,并鼓励开展未来的研究,招募更大,更多样化的队列,以进一步探讨其疗效.
Pregnant patients with SARS-CoV-2 infection are at increased risk for severe disease including hospitalization, intensive care admission, ventilatory support, and death. Although pregnant patients were excluded from investigational trials for pharmacologic treatments for COVID-19 illness, the National Institutes of Health treatment guidelines state that efficacious treatments should not be withheld from pregnant patients. An infusion of casirivimab and imdevimab (REGEN-COV), a monoclonal antibody therapy, was shown to reduce the risk of COVID-19-related hospitalization or death from any cause and resolved symptoms and reduced SARS-CoV-2 viral load more rapidly than placebo. In July of 2021, the Food and Drug Administration released an Emergency Use Authorization for REGEN-COV. Although pregnant persons were not included in the original trials, given the higher risk of morbidity and mortality in the pregnant population, our institution offered REGEN-COV to our pregnant patients beginning in August of 2021. Side effects after REGEN-COV administration are rare and thought to be secondary to COVID-19 rather than REGEN-COV.
This study aimed to track safety and clinical outcomes in unvaccinated pregnant patients who received REGEN-COV and to compare these outcomes with those of a contemporary cohort of patients who tested positive for SARS-CoV-2 and were eligible but did not receive REGEN-COV. Our hypothesis was that REGEN-COV administration during pregnancy is safe, and that pregnant persons who received REGEN-COV would experience less severe COVID-19 respiratory illness, with decreased length of hospital stay, rates of intensive care unit admission, and need for oxygen and other COVID-19 therapeutics.
This is a retrospective cohort study of pregnant patients who either tested positive for SARS-CoV-2 or had a known exposure to a COVID-19-positive person, and were therefore eligible for REGEN-COV at our institution. Within this cohort, we compared those who received REGEN-COV with those who did not between March and October of 2021 at Grady Memorial Hospital in Atlanta, Georgia. The main outcomes studied were perinatal outcomes, safety data, and the clinical course of SARS-CoV-2 infection.
From March to October of 2021, 86 pregnant people tested positive for SARS-CoV-2 via real-time polymerase chain reaction or had a confirmed exposure. In this group, 36 received REGEN-COV and 50 did not. There were no instances of infusion rate adjustment or discontinuation, anaphylaxis, or death among individuals who received REGEN-COV. One individual experienced worsening shortness of breath >24 hours after administration, which was classified as an infusion-related reaction. There were no significant differences in perinatal outcomes, length of hospitalization, rates of intensive care unit admission, additional pharmacologic treatment for COVID-19, or oxygen requirement between the 2 groups.
Administration of REGEN-COV is safe in pregnancy and did not increase adverse maternal, neonatal, or obstetrical outcomes. There was not a statistically significant difference in COVID-19-related outcomes in our high-risk population. Given the likely safety of this drug in pregnancy and its known benefits in the nonpregnant population, we advocate for the continued use of this therapy and encourage the development of future studies to enroll a larger and more diverse cohort to explore its efficacy further.