Oxygen Atomizing Inhalation of EGCG in the Treatment COVID-19 Pneumonia in Cancer Patients

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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. Thus, we designed this phase I-II clinical study in order to investigate the possible role of EGCG in tumor patients infected with SARS-CoV-2.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong Cancer Hospital and Institute

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 pneumonia, according to the diagnosis and treatment standard of COVID-19 in Peking Union Medical College Hospital

• Pulmonary function of the patient can be treated with aerosol inhalation for 5-7 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

• Need systemic use of immune suppressive agents