Can an oral drug stop COVID-19 pneumonia from turning deadly?
NCT ID NCT04569227
First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This trial tests whether the oral drug EC-18 can prevent mild or moderate COVID-19 pneumonia from progressing to severe pneumonia or acute respiratory distress syndrome (ARDS). Adults with confirmed COVID-19 pneumonia who do not yet need oxygen will receive either EC-18 or a placebo daily for 28 days. The main goal is to see if more people stay alive and free of respiratory failure with EC-18.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- EC-18, an oral drug taken daily
- What this could lead to
- If effective, EC-18 could offer a simple oral treatment to keep COVID-19 pneumonia from becoming severe, reducing the need for intensive care.
- What could go wrong
- This is an early Phase 2 trial, so results may not hold up in larger studies. The drug's safety and effectiveness are not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Started
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Apr 2021
- Expected to finish
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Nov 2021
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Kent County Memorial Hospital
Warwick, Rhode Island, 02886, United States
-
Lincoln Medical Center
The Bronx, New York, 10451, United States
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