Covid19 PneumoniaPhase 2NCT04569227
Prevention of COVID-19 Infection to Severe Pneumonia or ARDS
A Phase 2 study testing EC-18 in people with Covid19 Pneumonia, run by Enzychem Lifesciences Corporation at 2 sites in United States.
Trial summary
A trial of EC-18 in patients with mild/moderate pneumonia due to COVID-19 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19 Pneumonia
- What is being tested?
- EC-18
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Dec 2026to 1 Jan 2028
- Phase
- Phase 2
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
- Subjects must meet all of the following criteria:
- Male or female ≥18 years old
- 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.)
- Those who can tolerate oral administration
Show all 9Show fewer
- 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
- Those who are planned to be hospitalized or who are just hospitalized
- 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)
Who cannot join
- Subjects cannot participate in this clinical study if they satisfy any of the following criteria:
- Those who are diagnosed with viral pneumonia caused by other than COVID-19 or bacterial pneumonia during the screening
- 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%
- Patients with ARDS according to the WHO guidance
Show all 29Show fewer
- 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.
- 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)
- 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).
- 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
- Patients with uncontrolled diabetes (HbA1c > 7.0%)
- Those who have hypersensitivity reactions to the IP and its components
- 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
- 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
- Those who are considered to be ineligible to participate in the clinical study or have difficulty conducting this clinical study by the investigator
- Those subjects with Hb < lower limit of normal (LLN) for males and females
- Those subjects with a platelet count < LLN
- Those subjects with a WBC < LLN
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ted Kim, M.B.A. contact
United States2 sites
Lincoln Medical Center
The Bronx, New York, 10451
Maryanne Guerrero
Nail Cemalovic, MD
Kent County Memorial Hospital
Warwick, Rhode Island, 02886
Joni Harris
Hadeel Zainah, MD
About this study
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
A trial of EC-18 in patients with mild/moderate pneumonia due to COVID-19
- Conditions
- Covid19 Pneumonia
- Being tested
- EC-18, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EC-18Drug
2000 mg PO daily
PlaceboDrug
PO daily
| Study group | Role | What they receive |
|---|---|---|
| Active EC-18 | Experimental | Not described Receives: Drug: EC-18 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients alive and free of respiratory failure through at Day 28
Measured: 28 days
Secondary outcomes (9)
Probability of progression of mild pneumonia patients to severe pneumonia or ARDS within 28 days
Measured: 28 days
Assessment of all-cause mortality
Measured: 28 days
Respiratory failure defined based on resource utilization requiring at least 1 of the following:
- Endotracheal intubation and mechanical ventilation
- Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates > 20L/min with a fraction of delivered oxygen ≥ 0.5)
- Non-invasive positive pressure ventilation
- Extracorporeal membrane oxygenation
Measured: 28 days
Proportion of patients alive and free of invasive mechanical ventilation at a pre-specified timepoint
Measured: 28 days
Proportion of patients alive and discharged from the hospital at a pre-specified timepoint
Measured: 28 days
Lengths of ICU stay
Measured: 28 days
Lengths of alive and respiratory failure-free days
Measured: 28 days
Proportion of patients with objective measures of improvement (returning to room air) at time points (days 7, 14, and 28)
Measured: 7, 14, and 28 days
Confirmation of changes in subject's subjective clinical symptoms (e.g., patient questionnaire)
- Check for changes in symptoms on a daily basis for 28 days compared to the baseline at day 1
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start30 Dec 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19 PneumoniaStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Enzychem Lifesciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569227
- Sponsor's protocol ID
- EC-18-204
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2020
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No