Riccardo Buonomo A, Gabriele Saccone, Nunzia Esposito, Isabella Di Filippo, Biagio Pinchera, Maria Foggia, Emanuela Zappulo, Agnese Giaccone, Nicola Schiano M, Giulio Viceconte, Riccardo Scotto, Giuseppe Bifulco, Ivan Gentile
Section of Infectious Diseases, Department of Clinical Medicine and Surgery, University of Naples Federico II Naples, Naples, Italy.
Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.
Am J Perinatol. 2024 May;41(S 01):e612-e616. doi: 10.1055/a-1925-2017. Epub 2022 Aug 16.
Our objective was to evaluate the safety and efficacy of casirivimab/imdevimab therapy in pregnant women with severe coronavirus disease 2019 (COVID-19) requiring oxygen therapy.
This was a prospective case series study aimed to evaluate the safety and efficacy of casirivimab/imdevimab therapy in unvaccinated pregnant women with severe COVID-19. Inclusion criteria were severe acute respiratory syndrome coronavirus 2 infection documented with polymerase chain reaction, pregnancy, severe COVID-19 requiring oxygen therapy, duration of symptoms of 10 days or less, and able to provide informed consent. Vaccinated women and those with mild-to-moderate disease were excluded from the study. Included patients received casirivimab and imdevimab as a single intravenous dose of 4,000/4,000 mg. Women were also treated with low molecular weight heparin, steroids, and antibiotics, if necessary. The primary outcome was maternal death. Secondary outcomes were the rate of adverse events during infusion or within 72 hours and the rate of abortion.
Thirteen hospitalized unvaccinated pregnant women with severe COVID-19 requiring oxygen and treated with casirivimab/imdevimab were included in the study. We observed no maternal death, and no patients required intubation or admission to the intensive care unit. No abortion or fetal loss was recorded. Nine pregnancies were still ongoing, and there were three cesarean deliveries and one vaginal delivery. Two were preterm deliveries (at 31 and 34 weeks), and two were term deliveries.
Casirivimab/imdevimab therapy may be considered as a therapy in unvaccinated pregnant women with severe COVID-19.
我们的目的是评估卡西瑞维单抗/英夫利昔单抗疗法对需要吸氧治疗的重症2019冠状病毒病（COVID-19）孕妇的安全性和有效性。
这是一项前瞻性病例系列研究，旨在评估卡西瑞维单抗/英夫利昔单抗疗法对未接种疫苗的重症COVID-19孕妇的安全性和有效性。纳入标准为经聚合酶链反应确诊的严重急性呼吸综合征冠状病毒2感染、妊娠、需要吸氧治疗的重症COVID-19、症状持续时间为10天或更短，以及能够提供知情同意书。接种疫苗的妇女和患有轻至中度疾病的妇女被排除在研究之外。纳入的患者接受卡西瑞维单抗和英夫利昔单抗单次静脉注射剂量为4000/4000mg。如有必要，妇女还接受低分子量肝素、类固醇和抗生素治疗。主要结局是孕产妇死亡。次要结局是输注期间或72小时内不良事件的发生率以及流产率。
13名住院的未接种疫苗的重症COVID-19孕妇需要吸氧并接受卡西瑞维单抗/英夫利昔单抗治疗，被纳入研究。我们未观察到孕产妇死亡，也没有患者需要插管或入住重症监护病房。未记录到流产或胎儿丢失。9例妊娠仍在继续，有3例剖宫产和1例阴道分娩。2例为早产（分别在31周和34周），2例为足月分娩。
卡西瑞维单抗/英夫利昔单抗疗法可被视为未接种疫苗且患有重症COVID-19孕妇的一种治疗方法。
