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

NCT06924749 | Completed Phase 2

• 1 other identifier: GTEEC2023
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pneumonia, Interstitial; Cancer Patients

Keywords

EGCG

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Safety evaluations

  baseline and up to 7 days post-treatment

• Symptom resolution of COVID-19

  baseline and up to 7 days post-treatment

• Symptom resolution of COVID-19

  Baseline before treatment and 7 days after treatment

Other Outcomes (1)

• Changes in hematological biomarkers

  Baseline before treatment and 7±3 days after treatment

Study Arms (2)

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.

Drug: EGCG

Conventional Treatment Group

NO INTERVENTION

The Conventional Treatment Group was treated with the existing standard drugs.

Interventions

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.

Also known as: epigallocchin-3-gallate

EGCG#Epigallocatechin-3-gallate #

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (2)

Shan Dong cancer hospital and institute

Jinan, Shandong, 250117, China

Location

Hanxi Zhao

Jinan, Shandong, Shandong Cancer Hospital, China

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Xing Ligang, MD,PhD

  Shandong Cancer Hospital and Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: April 11, 2025
• Study Start: June 5, 2023
• Primary Completion: June 2, 2024
• Study Completion: July 2, 2024
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

CN (2)