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Epigallocatechin-3-gallate (EGCG) is a major polyphenol of green tea that possesses a wide variety of actions, such as anti-inflammatory, anti-fibrotic, pro-apoptotic, anti-tumorous, and metabolic effects via modulation of a variety of intracellular signaling cascades. In addition, preclinical studies have also emphasized the antiviral activity of epigallocatechin-3-gallate (EGCG), including SARS-CoV-2. In previous studies, we found that EGCG can prevent and cure radiation- induced normal tissue damage in tumor patients. In clinical studies, we found that EGCG can prevent and treat radiation-induced acute radiation esophagitis, acute radiation skin injury, acute radiation oral mucositis with high safety. At the same time, the phase I clinical trial designed by us has confirmed the safety and efficacy of EGCG in the treatment of interstitial pneumonia.
The Phase II study was conducted with a randomized, controlled, placebo dose determined by Phase I. the subjects were divided into two groups (experimental group and placebo group). To observe the effectiveness of EGCG, the researchers will use both clinician assessment and patient self-assessment. Primary endpoint: change in imaging (chest CT) before and after treatment. Secondary evaluation endpoints: 1 Further evaluation of the safety of EGCG. 2 The degree of symptom improvement . 3 Changes in laboratory testing indicators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EGCG#Epigallocatechin-3-gallate # | Experimental | Patients randomized to the EGCG group received nebulized EGCG (5878 µmol/L, 10 mL three times daily) plus standard care. The EGCG formulation (HPLC purity ≥98%, Ningbo Hepu Biotechnology Co., Ltd.) was prepared as a 0.9% normal saline solution for nebulization. The protocol-defined treatment duration was 7 days, with optional patient-directed continuation for up to 14 days or until initiation of anti-tumor therapy, whichever occurred first. |
|
| Conventional Treatment Group | No Intervention | The Conventional Treatment Group was treated with the existing standard drugs. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EGCG | Drug | EGCG (high pressure liquid chromatographic purity ≥ 95%; from Ningbo Hepu Biotechnology Co., Ltd.) is dissolved in 0.9% normal saline; 10ml is inhaled by atomization three times a day. |
| Measure | Description | Time Frame |
|---|---|---|
| CT imaging improvement rate of COVID-19 | The number of patients with various outcomes in the two groups was assessed. CT scans were performed before and after treatment, and evaluations of improvement, stability, and deterioration were made according to the assessment criteria from previous studies. | Baseline before treatment and 7±3 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluations | The incidence of adverse events between the two groups was evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | baseline and up to 7 days post-treatment |
| Symptom resolution of COVID-19 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in hematological biomarkers | Hematological biomarkers such as lactate dehydrogenase, lymphocyte count, platelet count, D-dimer, C-reactive protein, aspartate aminotransferase, alanine aminotransferase, creatinine, procalcitonin , and creatine kinase have previously been identified as associated with clinical outcomes in COVID-19. The levels of these biomarkers were tested using biochemical analysis. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xing Ligang, MD,PhD | Shandong Cancer Hospital and Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shan Dong cancer hospital and institute | Jinan | Shandong | 250117 | China | ||
| Hanxi Zhao |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41549240 | Derived | Zhu W, Jia L, Qiao Q, Li X, Peng X, Meng X, Kong L, Zhao H. Efficacy and safety of 7-day aerosolized epigallocatechin-3-gallate in oncologic patients with COVID-19 pneumonia. BMC Cancer. 2026 Jan 19;26(1):235. doi: 10.1186/s12885-026-15553-x. |
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| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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CT evaluations were performed by a separate radiologist blinded to both treatment allocation and potential imaging artifacts. Subjective endpoints (e.g., COVID-19 symptoms) were collected via patient self-reporting, entirely recorded by the participants themselves to minimize human interference.
|
Differences in COVID-19 Symptom Scores Between the Two Groups Patients assessed the severity of COVID-19-related symptoms daily using a 4-point scale (0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms). |
| baseline and up to 7 days post-treatment |
| Symptom resolution of COVID-19 | The number of patients with various COVID-19 symptom outcomes in the two groups was assessed. At the final evaluation, patients compared their symptoms with the baseline to determine whether the symptoms had remained stable, improved, or worsened. | Baseline before treatment and 7 days after treatment |
| Baseline before treatment and 7±3 days after treatment |
| Jinan |
| Shandong |
| Shandong Cancer Hospital |
| China |