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

Sponsor
Shandong Cancer Hospital and Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05758571
Collaborator
(none)
78
Enrollment
1
Location
2
Arms
36
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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. 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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

In this phase I study, subjects were divided into four dose groups according to the improved Fibonacci method and were given different doses of EGCG to evaluate adverse events. At the same time, the researchers conducted a phase II study of EGCG in tumor patients with COVID-19 pneumonia. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
78 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Oxygen Atomizing Inhalation of EGCG in the Treatment COVID-19 Pneumonia in Cancer Patients: Phase I-II Clinical Trial
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: EGCG（Epigallocatechin-3-gallate ）

Epigallocatechin-3-gallate (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. From the beginning of the diagnosis and 7 days after the signing of the informed consent form, the medication can be continued according to the wishes of the patients, but the total medication time is not more than 14 days.

Drug: 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.
Other Names:
  • epigallocchin-3-gallate

    		•
    Placebo Comparator: 0.9% saline solution

    The placebo is 0.9% saline solution.

    Drug: Placebo
    10ml 0.9% saline solution is inhaled by atomization three times a day.

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With EGCG-Related Adverse Events as Assessed by CTCAE v4.0 [through study completion, an average of 1 year]

      CTCAE v4.0 is an international standard for evaluating adverse event to cancer treatment.

    2. Changes of imaging examination (chest CT) after administration [up to 2 weeks]

      The changes of lung before and after treatment were judged by CT chest with or without contrast.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts 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 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shandong Cancer Hospital Jinan Shandong China 250117

    Sponsors and Collaborators

    • Shandong Cancer Hospital and Institute

    Investigators

    • Study Chair: Ligang Xing, MD, PhD, Shandong Cancer Hospital and Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Han Xi Zhao, Principal investigator, Shandong Cancer Hospital and Institute
    ClinicalTrials.gov Identifier:
    NCT05758571
    Other Study ID Numbers:
    • GTEBC-2023
    First Posted:
    Mar 7, 2023
    Last Update Posted:
    Mar 7, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Han Xi Zhao, Principal investigator, Shandong Cancer Hospital and Institute
    EGCG
    Additional relevant MeSH terms:
    COVID-19
    Pneumonia
    Neoplasms

    Study Results

    No Results Posted as of Mar 7, 2023