Infectious Diseases Division, Warren Alpert Medical School of Brown University, Providence, Rhode Island, USA.
School of Electrical and Computer Engineering, National Technical University of Athens, Athens, Greece.
J Infect Dis. 2023 Jan 11;227(2):226-235. doi: 10.1093/infdis/jiac362.
Thymosin-α-1 (Tα1) may be a treatment option for coronavirus disease 2019 (COVID-19), but efficacy and safety data remain limited.
Prospective, open-label, randomized trial assessing preliminary efficacy and safety of thymalfasin (synthetic form of Tα1), compared with the standard of care, among hospitalized patients with hypoxemia and lymphocytopenia due to COVID-19.
A total of 49 patients were included in this analysis. Compared with control patients, the incidence of clinical recovery was higher for treated patients with either baseline low-flow oxygen (subdistribution hazard ratio, 1.48 [95% confidence interval, .68-3.25]) or baseline high-flow oxygen (1.28 [.35-4.63]), although neither difference was significant. Among patients with baseline low-flow oxygen, treated patients, compared with control patients, had an average difference of 3.84 times more CD4+ T cells on day 5 than on day 1 (P = .01). Nine serious adverse events among treated patients were deemed not related to Tα1.
Tα1 increases CD4+ T-cell count among patients with baseline low-flow oxygen support faster than the standard of care and may have a role in the management of hospitalized patients with hypoxemia and lymphocytopenia due to COVID-19.
NCT04487444.
胸腺肽-α1（Tα1）可能是治疗 2019 年冠状病毒病（COVID-19）的一种选择，但疗效和安全性数据仍然有限。
这是一项前瞻性、开放标签、随机试验，评估胸腺法新（Tα1 的合成形式）与 COVID-19 导致低氧血症和淋巴细胞减少症的住院患者的标准治疗相比的初步疗效和安全性。
共有 49 名患者纳入本分析。与对照组相比，基线低流量吸氧的治疗患者（亚分布危险比，1.48 [95%置信区间，.68-3.25]）或基线高流量吸氧的治疗患者（1.28 [.35-4.63]）的临床康复发生率更高，尽管这两种差异均无统计学意义。在基线低流量吸氧的患者中，与对照组相比，治疗患者在第 5 天的 CD4+T 细胞数量平均多 3.84 倍（P =.01）。在治疗患者中发生的 9 例严重不良事件被认为与 Tα1 无关。
Tα1 使基线低流量氧支持的患者中的 CD4+T 细胞计数增加速度快于标准治疗，可能在管理 COVID-19 导致的低氧血症和淋巴细胞减少症的住院患者中发挥作用。
NCT04487444。
