Pneumonia, InterstitialPhase 2NCT06924749
Study of of Oxygen Nebulized Inhalation EGCG in Cancer Patients With New Coronary Pneumonia
A Phase 2 study testing EGCG in people with Pneumonia, Interstitial and Cancer Patients, run by Shandong Cancer Hospital and Institute at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Interstitial, Cancer Patients
- What is being tested?
- EGCG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 2 sitesChina
- Study dates
- 5 Jun 2023to 2 Jul 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
Shan Dong cancer hospital and institute
Jinan, Shandong, 250117
Hanxi Zhao
Jinan, Shandong, Shandong Cancer Hospital
About this study
Official title: Study of of Oxygen Nebulized Inhalation EGCG in Cancer Patients With New Coronary：Phase II Clinical Trial
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.
Read the 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.
- Conditions
- Pneumonia, Interstitial, Cancer Patients
- Being tested
- EGCG
- Keywords
- EGCG
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGCGDrug
Also called epigallocchin-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.
| Study group | Role | What they receive |
|---|---|---|
| EGCG#Epigallocatechin-3-gallate # | Experimental | Patients randomized to the EGCG group received nebulized EGCG (5878 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. Receives: Drug: EGCG |
| Conventional Treatment Group | No intervention | The Conventional Treatment Group was treated with the existing standard drugs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CT imaging improvement rate of COVID-19
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.
Measured: Baseline before treatment and 7±3 days after treatment
Secondary outcomes (3)
Safety evaluations
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
Measured: baseline and up to 7 days post-treatment
Symptom resolution of COVID-19
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).
Measured: baseline and up to 7 days post-treatment
Symptom resolution of COVID-19
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.
Measured: Baseline before treatment and 7 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start5 Jun 2023
- Primary completion2 Jun 2024
- Study completion2 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, InterstitialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Xi Zhao, Shandong Cancer Hospital and Institute
- Investigators
- Xing Ligang, MD,PhD, Study chair, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924749
- Sponsor's protocol ID
- GTEEC2023
- Status last verified
- Nov 2025
- First submitted
- 22 Aug 2023
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhu W, Jia L, Qiao Q, Li X, Peng X, Meng X, Kong L, Zhao H. Efficacy and safety of 7-day aerosolized epigallocatechin-3-gallate in oncologic patients with COVID-19 pneumonia. BMC Cancer. 2026 Jan 19;26(1):235. doi: 10.1186/s12885-026-15553-x.
PubMed 41549240
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of of Oxygen Nebulized Inhalation EGCG in Cancer Patients With New Coronary：Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT06924749
- Acronym / sponsor ID
- GTEEC2023
- Conditions
- Pneumonia, Interstitial, Cancer Patients
- Keywords
- EGCG
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 2 Jun 2024 (actual)
- Study completion
- 2 Jul 2024 (actual)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EGCG#Epigallocatechin-3-gallate # | Experimental | Drug: EGCGPatients randomized to the EGCG group received nebulized EGCG (5878 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. |
| Conventional Treatment Group | No intervention | –The Conventional Treatment Group was treated with the existing standard drugs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EGCGAlso: epigallocchin-3-gallateEGCG (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. | Drug | EGCG#Epigallocatechin-3-gallate # |
Primary outcome
CT imaging improvement rate of COVID-19
Time frame: 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.
3 secondary outcomes
Safety evaluations
Time frame: baseline and up to 7 days post-treatment
Symptom resolution of COVID-19
Time frame: baseline and up to 7 days post-treatment
Symptom resolution of COVID-19
Time frame: Baseline before treatment and 7 days after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Derived from this study: PubMed 41549240Zhu W, Jia L, Qiao Q, Li X, Peng X, Meng X, Kong L, Zhao H. Efficacy and safety of 7-day aerosolized epigallocatechin-3-gallate in oncologic patients with COVID-19 pneumonia. BMC Cancer. 2026 Jan 19;26(1):235. doi: 10.1186/s12885-026-15553-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xing Ligang, MD,PhD study chair
Shandong Cancer Hospital and Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EGCG in people with Pneumonia, Interstitial and Cancer Patients, run by Shandong Cancer Hospital and Institute at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CT imaging improvement rate of COVID-19 (time frame: Baseline before treatment and 7±3 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06924749, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.