Department of Respiratory Medicine, Japanese Red Cross Medical Center, Tokyo, Japan.
Drug Discov Ther. 2022 Jul 20;16(3):124-127. doi: 10.5582/ddt.2022.01036. Epub 2022 Jun 25.
Although sotrovimab, one of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing antibodies has been shown to be effective in patients with mild-to-moderate coronavirus disease 2019 (COVID-19) with risk factors, their efficacy in mRNA COVID-19 vaccinated patients in omicron era is unknown. To evaluate the effectiveness of sotrovimab clinical data from both COVID-19 vaccinated and unvaccinated patients who were hospitalized and receiving sotrovimab at the Japanese Red Cross Medical Center were compared. The efficacy and adverse events were evaluated. Of the total 60 patients enrolled in this study, 45 had received the mRNA COVID-19 vaccine and 15 were unvaccinated. The clinical progression with low nasal cannula or face mask was not significantly different between groups (occurring in one patient in each group; p = 0.44), with no further progression in both groups. The duration of hospitalization was eight days for both groups (p = 0.90). Two patients in each group experienced adverse events (7%, p = 0.26). The results suggested that the efficacy and safety of sotrovimab against mild-to-moderate COVID-19 with risk factors in the omicron era might not be different regardless of the vaccination status. The results of the present study are encouraging; however, further randomized clinical studies are needed.
尽管有研究表明，针对严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）的中和抗体 sotrovimab 对有风险因素的轻症至中度 2019 冠状病毒病（COVID-19）患者有效，但在奥密克戎时代，mRNA COVID-19 疫苗接种者中其疗效尚不清楚。为了评估 sotrovimab 的疗效，比较了在日本红十字医疗中心住院并接受 sotrovimab 治疗的 COVID-19 疫苗接种者和未接种者的临床数据。评估了疗效和不良事件。本研究共纳入 60 例患者，其中 45 例接受了 mRNA COVID-19 疫苗接种，15 例未接种。两组患者低鼻导管或面罩治疗的临床进展无显著差异（每组各有 1 例患者；p = 0.44），两组均无进一步进展。两组的住院时间均为 8 天（p = 0.90）。两组各有 2 例患者发生不良事件（7%，p = 0.26）。结果表明，在奥密克戎时代，针对有风险因素的轻症至中度 COVID-19，sotrovimab 的疗效和安全性可能与疫苗接种状态无关。本研究结果令人鼓舞；然而，仍需要进一步的随机临床试验。
