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Recruiting
NCT05758571
Oxygen Atomizing Inhalation of EGCG in the Treatment COVID-19 Pneumonia in Cancer Patients
Conditions: COVID-19 Pneumonia, Neoplasms Malignant
Sex: All
Ages: 18 Years – 70 Years
Phase: PHASE1, PHASE2
Enrollment: 78
Sponsor: Shandong Cancer Hospital and Institute
Location: China
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.
Eligibility Criteria
Inclusion Criteria:Diagnosed malignant tumors by pathology or cytologyCOVID-19 with a confirmed positive polymerase chain reaction or antigen test result for SARS-CoV-23Moderate pneumonia, according to the diagnosis and treatment standard of COVID-19 in Peking Union Medical College HospitalPulmonary function of the patient can be treated with aerosol inhalation for 5-7 daysExclusion Criteria:Current or recent progresses rapidly and may develop into a Critical illness with coronavirus in a short period of timeCaused by other viruses such as cytomegalovirus, as well as pneumocystis pneumonia, pulmonary edema, aspiration pneumonia and acute interstitial pneumoniaAny 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 participationNeed systemic use of immune suppressive agents
Source: ClinicalTrials.gov (NCT05758571). StuddyBuddy aggregates publicly available trial information.