Le Michelle, Khoury Lauren, Lu Yang, Prosty Connor, Cormier Maxime, Cheng Mathew P, Fowler Robert, Murthy Srinivas, Tsang Jennifer L Y, Ben-Shoshan Moshe, Rahme Elham, Golchi Shirin, Dendukuri Nandini, Lee Todd C, Netchiporouk Elena
Division of Dermatology, Department of Medicine, McGill University, Montreal, QC, Canada.
Faculty of Medicine, McGill University, Montreal, QC, Canada.
Open Forum Infect Dis. 2024 Feb 23;11(4):ofae102. doi: 10.1093/ofid/ofae102. eCollection 2024 Apr.
Omalizumab is an anti-immunoglobulin E monoclonal antibody used to treat moderate to severe chronic idiopathic urticaria, asthma, and nasal polyps. Recent research suggested that omalizumab may enhance the innate antiviral response and have anti-inflammatory properties.
We aimed to investigate the efficacy and safety of omalizumab in adults hospitalized for coronavirus disease 2019 (COVID-19) pneumonia.
This was a phase II randomized, double blind, placebo-controlled trial comparing omalizumab with placebo (in addition to standard of care) in hospitalized patients with COVID-19. The primary endpoint was the composite of mechanical ventilation and/or death at day 14. Secondary endpoints included all-cause mortality at day 28, time to clinical improvement, and duration of hospitalization.
Of 41 patients recruited, 40 were randomized (20 received the study drug and 20 placebo). The median age of the patients was 74 years and 55.0% were male. Omalizumab was associated with a 92.6% posterior probability of a reduction in mechanical ventilation and death on day 14 with an adjusted odds ratio of 0.11 (95% credible interval 0.002-2.05). Omalizumab was also associated with a 75.9% posterior probability of reduced all-cause mortality on day 28 with an adjusted odds ratio of 0.49 (95% credible interval, 0.06-3.90). No statistically significant differences were found for the time to clinical improvement and duration of hospitalization. Numerically fewer adverse events were reported in the omalizumab group and there were no drug-related serious adverse events.
These results suggest that omalizumab could prove protective against death and mechanical ventilation in hospitalized patients with COVID-19. This study could also support the development of a phase III trial program investigating the antiviral and anti-inflammatory effect of omalizumab for severe respiratory viral illnesses requiring hospital admission. ClinicalTrials.gov ID: NCT04720612.
奥马珠单抗是一种抗免疫球蛋白E单克隆抗体，用于治疗中度至重度慢性特发性荨麻疹、哮喘和鼻息肉。最近的研究表明，奥马珠单抗可能增强先天性抗病毒反应并具有抗炎特性。
我们旨在研究奥马珠单抗在因2019冠状病毒病（COVID-19）肺炎住院的成人患者中的疗效和安全性。
这是一项II期随机、双盲、安慰剂对照试验，在COVID-19住院患者中比较奥马珠单抗与安慰剂（除标准治疗外）。主要终点是第14天的机械通气和/或死亡复合终点。次要终点包括第28天的全因死亡率、临床改善时间和住院时间。
在招募的41名患者中，40名被随机分组（20名接受研究药物，20名接受安慰剂）。患者的中位年龄为74岁，55.0%为男性。奥马珠单抗与第14天机械通气和死亡减少的后验概率为92.6%相关，调整后的优势比为0.11（95%可信区间0.002 - 2.05）。奥马珠单抗与第28天全因死亡率降低的后验概率为75.9%相关，调整后的优势比为0.49（95%可信区间，0.06 - 3.90）。临床改善时间和住院时间未发现统计学显著差异。奥马珠单抗组报告的不良事件在数量上较少，且没有与药物相关的严重不良事件。
这些结果表明，奥马珠单抗可能对COVID-19住院患者的死亡和机械通气具有保护作用。本研究也可为开展III期试验项目提供支持，该项目旨在研究奥马珠单抗对需要住院治疗的严重呼吸道病毒疾病的抗病毒和抗炎作用。ClinicalTrials.gov标识符：NCT04720612。
