Study of of Oxygen Nebulized Inhalation EGCG in Cancer Patients With New Coronary Pneumonia

Study of of Oxygen Nebulized Inhalation EGCG in Cancer Patients With New Coronary：Phase II Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Cancer Patients; Pneumonia, Interstitial
• Intervention / Treatment: Drug: EGCG

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250117
      • Shan Dong cancer hospital and institute
    • Jinan, Shandong, China, Shandong Cancer Hospital
      • Hanxi Zhao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed malignant tumors by pathology or cytology
• COVID-19 with a confirmed positive polymerase chain reaction or antigen test result for SARS-CoV-23
• moderate-to-severe COVID-19 pneumonia (defined as any radiographic evidence of pulmonary infiltrates and oxygen saturation >94% on room air)
• Pulmonary function of the patient can be treated with aerosol inhalation for 7 days

Exclusion Criteria:

• Current or recent progresses rapidly and may develop into a Critical illness with coronavirus in a short period of time
• Caused by other viruses such as cytomegalovirus, as well as pneumocystis pneumonia, pulmonary edema, aspiration pneumonia and acute interstitial pneumonia
• Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator would preclude the participant from adhering to the protocol or would increase the risk associated with study participation
• known allergy or hypersensitivity to EGCG

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Conventional Treatment Group; The Conventional Treatment Group was treated with the existing standard drugs.
Experimental: EGCG#Epigallocatechin-3-gallate #; 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.	Drug: EGCG; 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.; Other Names: epigallocchin-3-gallate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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.	Baseline before treatment and 7±3 days after treatment

Collaborators and Investigators

• Sponsor: Shandong Cancer Hospital and Institute
• Investigators: Study Chair: Xing Ligang, MD,PhD, Shandong Cancer Hospital and Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2023
• Primary Completion (Actual): June 2, 2024
• Study Completion (Actual): July 2, 2024

Study Registration Dates

• First Submitted: August 22, 2023
• First Submitted That Met QC Criteria: April 6, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 23, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: EGCG
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: GTEEC2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No