Efficacy and safety of 7-day aerosolized epigallocatechin-3-gallate in oncologic patients with COVID-19 pneumonia.
- 2026-01-19
- BMC cancer 26(1)
- Wanqi Zhu
- Li Jia
- Qiang Qiao
- Xiaolin Li
- Xie Peng
- Xiangjiao Meng
- Lingling Kong
- Hanxi Zhao
- PubMed: 41549240
- DOI: 10.1186/s12885-026-15553-x
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 114
- Population
- 108 oncologic patients with COVID-19 pneumonia
- Methods
- Phase II, open-label, randomized controlled trial; 7-day aerosolized EGCG plus standard treatment vs standard treatment alone
- Blinding
- Open-label
- Duration
- 7 days
- Funding
- Unclear
- Large Human Trial
BACKGROUND: Oncologic patients are vulnerable to prolonged or severe COVID-19 due to immunosuppression and comorbidities. Our initial Phase I/II clinical trial has showed that epigallocatechin-3-gallate (EGCG), a catechin monomer isolated from tea, exhibits favorable safety profiles with therapeutic effects against COVID-19 pneumonia. This phase II, open-label, randomized controlled trial further evaluated the efficacy and safety of 7-day aerosolized epigallocatechin-3-gallate (EGCG) in oncologic patients with COVID-19 pneumonia. METHODS: This trial was conducted from June 2023 to May 2024. Patients were randomized (2:1) to receive aerosolized EGCG plus standard treatment or standard treatment alone. The primary endpoint was CT imaging improvement. Secondary endpoints included symptom resolution and the safety of EGCG. RESULTS: 114 patients were randomized, with 108 eligible (71 in EGCG group, 37 in control group). The EGCG group showed significantly greater CT improvement (P = 0.004) and faster symptom resolution for fever (P = 0.035), cough (P = 0.048), and dyspnea (P = 0.015). Improvement rates were higher in the EGCG group for fever (95% confidence interval: 1.380 -10.352) and dyspnea (95% confidence interval:1.750-60.446). Post-treatment lactate dehydrogenase levels were significantly lower in the EGCG group (P = 0.028). Safety profiles were comparable, with only mild adverse events observed in the EGCG group. CONCLUSIONS: Aerosolized EGCG significantly improved both radiological and clinical outcomes with a favorable safety profile in oncologic patients with COVID-19 pneumonia, although broader application requires further validation in larger multi-center trials. TRIAL REGISTRY: ClinicalTrials.gov, TRN: NCT06924749, Registration date: 22 August 2023.
Research Insights
The EGCG group showed significantly greater CT improvement (P = 0.004)
- Effect
- Beneficial
- Effect size
- Moderate
Post-treatment lactate dehydrogenase levels were significantly lower in the EGCG group (P = 0.028)
- Effect
- Beneficial
- Effect size
- Small
faster symptom resolution for cough (P = 0.048)
- Effect
- Beneficial
- Effect size
- Small
faster symptom resolution for dyspnea (P = 0.015)
- Effect
- Beneficial
- Effect size
- Large
faster symptom resolution for fever (P = 0.035)
- Effect
- Beneficial
- Effect size
- Moderate
Adverse Events Reported
Safety profiles were comparable, with only mild adverse events observed in the EGCG group.
- Finding
- Reported
- Grade
- mild