COVID-19Phase 2/3NCT05525182
Efficacy and Safety of ES16001 in Patients With COVID-19
A Phase 2/3 study testing ES16001 40 mg, ES16001 80 mg and ES16001 160 mg in people with COVID-19, run by Genencell Co. Ltd. at 3 sites in South Korea.
Trial summary
This is phase II/III, randomized, parallel-group, double-blind, placebo-controlled study. Patients must be at least 19 years of age (or according to the legal age for adult in each country) with confirmed mild or moderate COVID-19 tested positive with a real time reverse transcription polymerase chain reaction… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- ES16001 40 mg, ES16001 80 mg and ES16001 160 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 706 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 5 Jul 2021to 31 Dec 2023
- Phase
- Phase 2/3
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those with full understanding of the clinical study and agreeing with the participation of the clinical study voluntarily in writing, or with a deputy granted with legal authority of the relevant patient if he/she is unable to agree with the clinical study in person
- Adults aged at 19 or above at the time of screening examination (according to the legal age for adult in each country)
- Diagnosis of COVID-19 including a positive real time reverse transcription polymerase chain reaction (RT-PCR) for severe acute respiratory syndrome (SARS)-CoV-2 within 4 days prior to administering the investigational produce (IP)
- mild or moderate patients who have the following conditions at screening and confirm at randomization at randomization A. Mild: Those with COVID-19 symptoms relevant to the inclusion criteria 5 without breathing difficulty or other chest radiation examination B. Moderate: Those with disease in respiratory organs in the clinical evaluation or imaging examination (chest radiation examination, etc.) and also relevant to the following conditions
- Higher than 94% of oxygen saturation (Sp02) with room air at screening
- Lower than 30 times/min respiratory frequency at screening
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- Those who happen more than one of the following symptoms within 4 days prior to the treatment of investigational medicinal product (IMP) and also have more than one of symptoms within a day prior to the treatment of IMP:
- Fever
- Cough
- Shortness of breath
- Chills
- Muscle pain
- Headache
- Sore throat
- Loss of smell/taste
- Nasal congestion
- Runny nose
- Fatigue
- Nausea or vomiting
- Diarrhea
- Phlegm
- Those being hospitalized or scheduled in hospital or quarantined facilities or home isolated
- Those comply with the clinical study protocol
- Female patients of childbearing potential and male patients with partners of childbearing potential must agree to use adequate methods of contraception during the study and through 90 days after the last dose of study medication. Female patients of childbearing potential are all those except patients who are surgically sterile, who have medically documented ovarian failure, or who are at least 1 year postmenopausal. Effective contraception includes an established hormonal therapy or intrauterine device for females, and the use of a barrier contraceptive (i.e. diaphragm or condoms) with spermicide.
Who cannot join
- Those with known or suspected hypersensitivity to ES16001 or any of its excipients
- Those with genetic issues with galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption, etc.
- Patients with ECG evidence of a QTcF > 450 ms in men and > 470 ms in women and patients with any other risk factors for Torsades de pointes (TdP) (hypokalemia, hypomagnesemia or hypocalcemia, family history of long QT syndrome, low left ventricular ejection fraction, left ventricular hypertrophy, ischemia and slow heart rate)
- Concomitant use of hydroxychloroquine or other drugs known to prolong QT interval throughout the study 5. Suspected active bacterial, fungal, viral, or other infection (besides COVID-19).
- 6. Immunosuppressor or immunomodulatory drugs within the past 3 months (excluding corticosteroids) and patients with autoimmune disease.
- 7. Patients with one of the following severe COVID-19 signs at randomization (based on NIH classification)
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- Oxygen saturation (SpO2) <94% of oxygen saturation without oxygen supply in room air
- Partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) <300 mmHg
- Respiratory frequency >30 times/min
- Parenchyma infiltration> 50% 8. Patients requiring oxygen treatment (nasal prong, facial mask, and high flow oxygen) or machine respiration (oxygen by NIV or high flow, intubation and mechanical ventilation, and etc.) at randomization 9. Those requiring extracorporeal membrane oxygenation (ECMO) or continuous renal replacement therapy (CRRT) treatment due to damage on multiple organs with severe illness (respiratory failure, shock, or multiple organ disorder) 10. Those with issues on kidney or liver as follows in the screening
- Alanine transaminase (ALT) or aspartate aminotransferase (AST) > 5 x upper limit of normal (ULN) at screening
- Total bilirubin that is 1.5 x upper limit of normal (ULN) at screening in the blood
- Serum creatine > 2mg/dL (> 176.8 μmol/L) or estimated creatine clearance < 30ml/min measured or calculated by Cockroft Gault equation 11. Absolute neutrophil count (ANC) <1000/μL in the screening 12. platelet count <50,000/μL in the screening 13. Those who are pregnant or breastfeeding 14. Treatment with an investigational product within 5 times half-life or to 30 days from the screening (whichever is longer) 15. Those taking antiviral drugs, anti-inflammatory medicine, or neutralizing antibody that is known to influence the treatment of COVID-19 (refer to 7.4.2 Prohibited medication) 16. Those with chronic disease that is inappropriate for the participation in clinical study judged by the investigator (Uncontrolled diabetes, chronic kidney disease, chronic liver disease, chronic lung disease, chronic cardiovascular disease, blood cancer, chemotherapeutic cancer patients, patients taking immunosuppressants, idiopathic thrombocytopenia, hyperkalemia patients, etc.)
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites, 3 recruiting
- Recruiting
Soon Chun Hyang University Hospital
Bucheon-si
Seong-on Cho, CRA, +82) 032-621-5795
Ansoo Jang
- Recruiting
Eunpyeong, St.Mary's Hospital
Seoul
Seong-on Cho, CRA, +82) 02-2030-3372
Sanghaak Lee
- Recruiting
Kyung Hee University Medical Center
Seoul
Selki Kim, CRA, +82 ) 02-958-9510
Misuk Lee
About this study
Official title: Efficacy and Safety of ES16001 in Patients With COVID-19: a Phase II/III, Multinational, Randomized, Parallel-group, Double-blind, Placebo-controlled Study
This is phase II/III, randomized, parallel-group, double-blind, placebo-controlled study. Patients must be at least 19 years of age (or according to the legal age for adult in each country) with confirmed mild or moderate COVID-19 tested positive with a real time reverse transcription polymerase chain reaction (RT-PCR) analysis of rhinopharynx samples. RT-PCR analysis of rhinopharynx samples must be <4 days old prior to the study enrolment
Read the detailed description
After obtaining the consent and confirming eligibility, eligible patients will be treated with investigational medicinal product (IMP) for 7 days and followed up for additional 21 days (total 29 days). Patients who are discharged from the hospital or ending the quarantine may have to visit the investigational site on a pre-determined date for efficacy and safety follow up observation. Final safety and efficacy data will be collected on the last study day (29th Day).
If patients are fully recovered or discharged from the hospital prior to treatment period, all the evaluations on the 7th day/End of Treatment examination treatment shall be performed on the day of discharging.
- Conditions
- COVID-19
- Being tested
- ES16001 40 mg, ES16001 80 mg, ES16001 160 mg, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ES16001 40 mgDrug
Also called 40 mg
Composition: Elaeocarpus extract 40mg tablet
ES16001 80 mgDrug
Also called 80 mg
Elaeocarpus extract 80 mg tablet
ES16001 160 mgDrug
Also called 160 mg
Elaeocarpus extract 160 mg tablet
PlaceboDrug
Placebo Tablet: Tablets for oral use indistinguishable from ES16001 in size, appearance, taste and smell
| Study group | Role | What they receive |
|---|---|---|
| Phase II | Experimental | ES16001: 480 mg/day ES16001: 720 mg/day ES16001: 960 mg/day Placebo Receives: Drug: ES16001 40 mg; Drug: ES16001 80 mg; Drug: ES16001 160 mg; Drug: Placebo |
| Phase III | Experimental | ES16001 Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase II
To determine the safe and effective dose of ES16001 versus placebo for the treatment of mild to moderate COVID-19. Proportion of subjects receiving the oxygen aiding treatment (nasal prong or facial mask) for at last 24 hours with oxygen saturation < 94% in room air prior to oxygen supply
- Proportion of subjects requiring invasive machine ventilation as well as the non-invasive machine ventilation
- Proportion of subjects applied with high flow oxygen or machine ventilation with oxygen saturation estimated to be less than 94% in room air
- Proportion of dead subjects
Measured: 2 months, last patient in (LPI) (Dec 22,23 respectively + 1 month Tx -> 2 months for database lock (DBL) and clinical study report (CSR)
Phase III
To demonstrate the superiority of ES16001 versus placebo for the treatment of mild to moderate COVID-19. Proportion of subjects receiving the oxygen aiding treatment (nasal prong or facial mask) for at last 24 hours with oxygen saturation < 94% in room air prior to oxygen supply
- Proportion of subjects requiring invasive machine ventilation as well as the non-invasive machine ventilation
- Proportion of subjects applied with high flow oxygen or machine ventilation with oxygen saturation estimated to be less than 94% in room air
- Proportion of dead subjects
Measured: 2 months, last patient in (LPI) (Dec 22,23 respectively + 1 month Tx -> 2 months for database lock (DBL) and clinical study report (CSR)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start5 Jul 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase II -Dose-finding Phase II will be enrolled 424 patients (1:1:1:1 ratio) randomly assigned to one of the four treatment groups as follows. * ES16001 480 mg /day * ES16001 720 mg /day * ES16001 960 mg /day * Placebo Phase III In the phase III, safety and efficacy with the dose selected in the phase II will be compared with placebo. In the phase III, about 706 patients will be randomized in 1:1 ratio to test drug or placebo. Randomization will be stratified depending on the well-known risk factors for progression and disease severity of a patient. Final Endpoints and the sample size may be different depending on the results of the phase II.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 706 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genencell Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jae-Hyun Park, Study chair, Genencell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525182
- Sponsor's protocol ID
- GNC_ESE_COVID19_P2-301
- Status last verified
- Feb 2023
- First submitted
- 21 Jul 2022
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of ES16001 in Patients With COVID-19: a Phase II/III, Multinational, Randomized, Parallel-group, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT05525182
- Acronym / sponsor ID
- GNC_ESE_COVID19_P2-301
- Conditions
- COVID-19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 706 participants (estimated)
- Lead sponsor
- Genencell Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 1 Sep 2022 (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.
This is phase II/III, randomized, parallel-group, double-blind, placebo-controlled study. Patients must be at least 19 years of age (or according to the legal age for adult in each country) with confirmed mild or moderate COVID-19 tested positive with a real time reverse transcription polymerase chain reaction (RT-PCR) analysis of rhinopharynx samples. RT-PCR analysis of rhinopharynx samples must be <4 days old prior to the study enrolment
Detailed description
After obtaining the consent and confirming eligibility, eligible patients will be treated with investigational medicinal product (IMP) for 7 days and followed up for additional 21 days (total 29 days). Patients who are discharged from the hospital or ending the quarantine may have to visit the investigational site on a pre-determined date for efficacy and safety follow up observation. Final safety and efficacy data will be collected on the last study day (29th Day).
If patients are fully recovered or discharged from the hospital prior to treatment period, all the evaluations on the 7th day/End of Treatment examination treatment shall be performed on the day of discharging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Phase II -Dose-finding Phase II will be enrolled 424 patients (1:1:1:1 ratio) randomly assigned to one of the four treatment groups as follows. * ES16001 480 mg /day * ES16001 720 mg /day * ES16001 960 mg /day * Placebo Phase III In the phase III, safety and efficacy with the dose selected in the phase II will be compared with placebo. In the phase III, about 706 patients will be randomized in 1:1 ratio to test drug or placebo. Randomization will be stratified depending on the well-known risk factors for progression and disease severity of a patient. Final Endpoints and the sample size may be different depending on the results of the phase II.
| Arm | Type | Receives |
|---|---|---|
| Phase II | Experimental | Drug: ES16001 40 mg, Drug: ES16001 80 mg, Drug: ES16001 160 mg, Drug: PlaceboES16001: 480 mg/day ES16001: 720 mg/day ES16001: 960 mg/day Placebo |
| Phase III | Experimental | Drug: PlaceboES16001 Placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Those with full understanding of the clinical study and agreeing with the participation of the clinical study voluntarily in writing, or with a deputy granted with legal authority of the relevant patient if he/she is unable to agree with the clinical study in person
- Adults aged at 19 or above at the time of screening examination (according to the legal age for adult in each country)
- Diagnosis of COVID-19 including a positive real time reverse transcription polymerase chain reaction (RT-PCR) for severe acute respiratory syndrome (SARS)-CoV-2 within 4 days prior to administering the investigational produce (IP)
- mild or moderate patients who have the following conditions at screening and confirm at randomization at randomization A. Mild: Those with COVID-19 symptoms relevant to the inclusion criteria 5 without breathing difficulty or other chest radiation examination B. Moderate: Those with disease in respiratory organs in the clinical evaluation or imaging examination (chest radiation examination, etc.) and also relevant to the following conditions
- Those who happen more than one of the following symptoms within 4 days prior to the treatment of investigational medicinal product (IMP) and also have more than one of symptoms within a day prior to the treatment of IMP:
Key exclusion criteria (13 listed)
- Those with known or suspected hypersensitivity to ES16001 or any of its excipients
- Those with genetic issues with galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption, etc.
- Patients with ECG evidence of a QTcF > 450 ms in men and > 470 ms in women and patients with any other risk factors for Torsades de pointes (TdP) (hypokalemia, hypomagnesemia or hypocalcemia, family history of long QT syndrome, low left ventricular ejection fraction, left ventricular hypertrophy, ischemia and slow heart rate)
- Concomitant use of hydroxychloroquine or other drugs known to prolong QT interval throughout the study 5. Suspected active bacterial, fungal, viral, or other infection (besides COVID-19).
- 6. Immunosuppressor or immunomodulatory drugs within the past 3 months (excluding corticosteroids) and patients with autoimmune disease.
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 |
|---|---|---|
| ES16001 40 mgAlso: 40 mgComposition: Elaeocarpus extract 40mg tablet | Drug | Phase II |
| ES16001 80 mgAlso: 80 mgElaeocarpus extract 80 mg tablet | Drug | Phase II |
| ES16001 160 mgAlso: 160 mgElaeocarpus extract 160 mg tablet | Drug | Phase II |
| PlaceboPlacebo Tablet: Tablets for oral use indistinguishable from ES16001 in size, appearance, taste and smell | Drug | Phase II, Phase III |
Primary outcome
Phase II
Time frame: 2 months, last patient in (LPI) (Dec 22,23 respectively + 1 month Tx -> 2 months for database lock (DBL) and clinical study report (CSR)
To determine the safe and effective dose of ES16001 versus placebo for the treatment of mild to moderate COVID-19. Proportion of subjects receiving the oxygen aiding treatment (nasal prong or facial mask) for at last 24 hours with oxygen saturation < 94% in room air prior to oxygen supply * Proportion of subjects requiring invasive machine ventilation as well as the non-invasive machine ventilation * Proportion of subjects applied with high flow oxygen or machine ventilation with oxygen saturation estimated to be less than 94% in room air * Proportion of dead subjects
Phase III
Time frame: 2 months, last patient in (LPI) (Dec 22,23 respectively + 1 month Tx -> 2 months for database lock (DBL) and clinical study report (CSR)
To demonstrate the superiority of ES16001 versus placebo for the treatment of mild to moderate COVID-19. Proportion of subjects receiving the oxygen aiding treatment (nasal prong or facial mask) for at last 24 hours with oxygen saturation < 94% in room air prior to oxygen supply * Proportion of subjects requiring invasive machine ventilation as well as the non-invasive machine ventilation * Proportion of subjects applied with high flow oxygen or machine ventilation with oxygen saturation estimated to be less than 94% in room air * Proportion of dead subjects
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Jae-Hyun Park study chair
Genencell
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ES16001 40 mg, ES16001 80 mg and ES16001 160 mg in people with COVID-19, run by Genencell Co. Ltd. at 3 sites in South Korea.
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 24 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae-Hyun (Jay) Park (+82 (0)70-7712-9784, chadol9270@genencell.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase II (time frame: 2 months, last patient in (LPI) (Dec 22,23 respectively + 1 month Tx -> 2 months for database lock (DBL) and clinical study report (CSR)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Feb 2023.