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

Phase 2

Completed

• Conditions: Pneumonia, Interstitial; Cancer Patients
• Interventions: Drug: EGCG

• Registration Number: NCT06924749
• Lead Sponsor: Shandong Cancer Hospital and Institute

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.

Study Timeline

• Study Start: 2023-06-05
• Study First Submitted: 2023-08-22
• Primary Completion: 2024-06-02
• Study Completion: 2024-07-02
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-06
• Last Update Submitted: 2025-04-06
• Study First Posted: 2025-04-11
• Last Update Posted: 2025-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EGCG#Epigallocatechin-3-gallate #	EGCG	Patients randomized to the EGCG group received nebulized EGCG (1760 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.

Primary Outcome Measures

Name	Time	Method
CT imaging improvement rate of COVID-19	Baseline before treatment and 7±3 days after treatment	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.

Secondary Outcome Measures

Name	Time	Method
Safety evaluations	baseline and up to 7 days post-treatment	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
Symptom resolution of COVID-19	Baseline before treatment and 7 days after treatment	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.

Trial Locations

Locations (2)

Shan Dong cancer hospital and institute; 🇨🇳 Jinan, Shandong, China

Hanxi Zhao; 🇨🇳 Jinan, Shandong, China