Cancer Patients, Pneumonia, Interstitial
Conditions
Keywords
EGCG
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.
Interventions
DRUGEGCG
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.
Sponsors
Shandong Cancer Hospital and Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 and up to 7 days post-treatment | Differences in COVID-19 Symptom Scores Between the Two Groups Patients assessed the severity of COVID-19-related symptoms daily using a 4-point scale (0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in hematological biomarkers | Baseline before treatment and 7±3 days after treatment | Hematological biomarkers such as lactate dehydrogenase, lymphocyte count, platelet count, D-dimer, C-reactive protein, aspartate aminotransferase, alanine aminotransferase, creatinine, procalcitonin , and creatine kinase have previously been identified as associated with clinical outcomes in COVID-19. The levels of these biomarkers were tested using biochemical analysis. |
Countries
China
Outcome results
None listed