Official Title
Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of EC-18 in Preventing the Progression of COVID-19 Infection to Severe Pneumonia or ARDS
Brief Summary

A trial of EC-18 in patients with mild/moderate pneumonia due to COVID-19

Unknown status
COVID19 Pneumonia

Drug: EC-18

2000 mg PO daily

Drug: Placebo

PO daily

Eligibility Criteria

Inclusion Criteria:

- Subjects must meet all of the following criteria:

1. Male or female ≥18 years old

2. Subjects with confirmed diagnoses of pneumonia caused by COVID-19 from:

- RT-PCR or Abbott ID Now COVID-19 test

- Chest X-ray or computed tomography (CT) scan (findings of the increased
opacity on a chest X-ray, ground-glass opacity indicative of pneumonia on
CT, opinion on consolidation, etc.)

3. Those who can tolerate oral administration

4. Those who do not need oxygen therapy or only need low-flow oxygen (at least
4L/min) but not requiring high-flow oxygen (higher than 4-6L/min) or
non-invasive/invasive ventilation primarily according to the WHO guidance

5. Those who are planned to be hospitalized or who are just hospitalized

6. Those who have been fully explained about this clinical study and have
voluntarily agreed to participate in this clinical study by signing the informed
consent form (ICF)

Exclusion Criteria:

- Subjects cannot participate in this clinical study if they satisfy any of the
following criteria:

1. Those who are diagnosed with viral pneumonia caused by other than COVID-19 or
bacterial pneumonia during the screening

2. Patients with severe pneumonia according to the WHO guidance

- Have fever or signs of respiratory infections and

- Satisfy any one of the following conditions: Respiratory rate > 30
breaths/min, severe respiratory distress, or room air oxygen saturation
(SpO2) ≤ 93%

3. Patients with ARDS according to the WHO guidance

4. Those who have past medical histories described below:

- Those who have medical histories of human immunodeficiency virus (HIV),
acquired immunodeficiency syndrome (AIDS), or hepatitis B or C viral
infection

- Those who cannot have a CT test done due to allergy to contrast agents, etc.

5. Those who have comorbidities/symptoms described below:

- Those who have a history or evidence of another clinically significant
condition that may pose risks to patient safety or interfere with the study
procedures, assessments or completion as determined by the investigator

- Those who have moderate or severe renal impairment (eGFR < 60 mL/min/1.73
m2)

- Those who have moderate or severe hepatic impairment (Child-Pugh B or C,
respectively)

6. Patients who are being treated with corticosteroids or other immunosuppressants
for asthma or autoimmune diseases at the entry of study are excluded, because
these drugs counteract the action mechanism of EC-18 (PLAG).

7. Those who have any abnormalities in laboratory tests described below:

- Clinically significant liver function abnormality (Satisfy any one or more
of the following):

- Serum alanine aminotransferase (ALT) ≥ upper limit of normal (ULN) × 2.5

- Serum aspartate aminotransferase (AST) ≥ ULN × 2.5

- Serum total bilirubin ≥ ULN × 2.5

8. Patients with uncontrolled diabetes (HbA1c > 7.0%)

9. Those who have hypersensitivity reactions to the IP and its components

10. Those who satisfy any of the descriptions below:

- Pregnant or breastfeeding female subjects

- Those who are planning on pregnancy or not using accepted contraception
measures during the clinical study

11. Those who have participated in other clinical studies to receive IPs or apply
investigational medical devices within 1 month from the time of obtaining the
informed consent

12. Those who are considered to be ineligible to participate in the clinical study or
have difficulty conducting this clinical study by the investigator

13. Those subjects with Hb < lower limit of normal (LLN) for males and females

14. Those subjects with a platelet count < LLN

15. Those subjects with a WBC < LLN

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Lincoln Medical Center
Bronx, New York, United States

Kent County Memorial Hospital
Warwick, Rhode Island, United States

Contacts

John Choi, M.S.
201-676-3804
john.choi@enzychem.com

Ji Sun Park, Ph.D.
201-676-3807
jisun.park@enzychem.com

Enzychem Lifesciences Corporation
NCT Number
MeSH Terms
COVID-19
Pneumonia