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

NCT ID: NCT06924749

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-05
• Study Completion Date: 2024-07-02

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.

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.

Conditions

Pneumonia, Interstitial; Cancer Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

EGCG

Intervention Type: 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.

Conventional Treatment Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

epigallocchin-3-gallate

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Cancer Hospital and Institute

OTHER

Sponsor Role: lead

Responsible Party

Han Xi Zhao

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xing Ligang, MD,PhD

Role: STUDY_CHAIR

Shandong Cancer Hospital and Institute

Locations

Shan Dong cancer hospital and institute

Jinan, Shandong, China

Hanxi Zhao

Jinan, Shandong, China

Countries

China

Other Identifiers

GTEEC2023

Identifier Type: -

Identifier Source: org_study_id