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
Brief 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 ineach country) with confirmed mild or moderate COVID-19 tested positive with a real timereverse transcription polymerase chain reaction (RT-PCR) analysis of rhinopharynxsamples. RT-PCR analysis of rhinopharynx samples must be

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.

Unknown status
COVID-19

Drug: ES16001 40 mg

Composition: Elaeocarpus extract 40mg tablet
Other Name: 40 mg

Drug: ES16001 80 mg

Elaeocarpus extract 80 mg tablet
Other Name: 80 mg

Drug: ES16001 160 mg

Elaeocarpus extract 160 mg tablet
Other Name: 160 mg

Drug: Placebo

Placebo Tablet: Tablets for oral use indistinguishable from ES16001 in size, appearance,
taste and smell

Eligibility Criteria

Inclusion Criteria:

1. 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

2. Adults aged at 19 or above at the time of screening examination (according to the
legal age for adult in each country)

3. 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)

4. 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

5. 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

6. Those being hospitalized or scheduled in hospital or quarantined facilities or home
isolated

7. Those comply with the clinical study protocol

8. 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.

Exclusion Criteria:

1. Those with known or suspected hypersensitivity to ES16001 or any of its excipients

2. Those with genetic issues with galactose intolerance, lapp lactase deficiency, or
glucose-galactose malabsorption, etc.

3. 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)

4. 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)

- 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

1. Alanine transaminase (ALT) or aspartate aminotransferase (AST) > 5 x upper
limit of normal (ULN) at screening

2. Total bilirubin that is 1.5 x upper limit of normal (ULN) at screening in the
blood

3. 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.)

Eligibility Gender
All
Eligibility Age
Minimum: 19 Years ~ Maximum: N/A
Countries
Korea, Republic of
Locations

Soon Chun Hyang University Hospital
Bucheon, Korea, Republic of

Eunpyeong, St.Mary's Hospital
Seoul, Korea, Republic of

Kyung Hee University Medical Center
Seoul, Korea, Republic of

Contacts

Jae-Hyun (Jay) Park
+82 (0)70-7712-9784
chadol9270@genencell.co.kr

Seonyu Kim
+82 (0)70-7711-9217
sykim@genencell.co.kr

Jae-Hyun Park, Study Chair
Genencell

Genencell Co. Ltd.
NCT Number
MeSH Terms
COVID-19