Phase I/II clinical trial of efficacy and safety of EGCG oxygen nebulization inhalation in the treatment of COVID-19 pneumonia patients with cancer

作者：Xiaoyan Yin, Wanqi Zhu, Xiaoyong Tang, Guangjian Yang, Xianguang Zhao, Kaikai Zhao, Liyang Jiang, Xiaolin Li, Hong Zhao, Hong Zhao, Xin Wang, Yuanyuan Yan, Ligang Xing, Jinming Yu, Xiangjiao Meng, Hanxi Zhao, Hanxi Zhao · 发表于：BMC Cancer · 年份：2024 · DOI：10.1186/s12885-024-12228-3 · 被引用次数：38 · 研究领域：Tea Polyphenols and Effects、COVID-19 Clinical Research Studies、COVID-19 and healthcare impacts

BACKGROUND: The antiviral drug Nirmatrelvir was found to be a key drug in controlling the progression of pneumonia during the infectious phase of COVID-19. However, there are very few options for effective treatment for cancer patients who have viral pneumonia. Glucocorticoids is one of the effective means to control pneumonia, but there are many adverse events. EGCG is a natural low toxic compound with anti-inflammatory function. Thus, this study was designed to investigate the safety and efficacy of epigallocatechin-3-gallate (EGCG) aerosol to control COVID-19 pneumonia in cancer populations. METHODS: The study was designed as a prospective, single-arm, open-label phase I/II trial at Shandong Cancer Hospital and Institute, between January 5, 2023 to March 31,2023 with viral pneumonia on radiographic signs after confirmed novel coronavirus infection. These patients were treated with EGCG nebulization 10 ml three times daily for at least seven days. EGCG concentrations were increased from 1760-8817umol/L to 4 levels with dose escalation following a standard Phase I design of 3-6 patients per level. Any grade adverse event caused by EGCG was considered a dose-limiting toxicity (DLT). The maximum tolerated dose (MTD) is defined as the highest dose with less than one-third of patients experiencing dose limiting toxicity (DLT) due to EGCG. The primary end points were the toxicity of EGCG and CT findings, and the former was graded by Common Terminology Criteria for Adverse Events ...