Prevention of COVID-19 Infection to Severe Pneumonia or ARDS
- Registration Number
- NCT04569227
- Lead Sponsor
- Enzychem Lifesciences Corporation
- Brief Summary
A trial of EC-18 in patients with mild/moderate pneumonia due to COVID-19
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
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Subjects must meet all of the following criteria:
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Male or female ≥18 years old
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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.)
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Those who can tolerate oral administration
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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
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Those who are planned to be hospitalized or who are just hospitalized
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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)
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Subjects cannot participate in this clinical study if they satisfy any of the following criteria:
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Those who are diagnosed with viral pneumonia caused by other than COVID-19 or bacterial pneumonia during the screening
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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%
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Patients with ARDS according to the WHO guidance
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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.
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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)
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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).
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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
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Patients with uncontrolled diabetes (HbA1c > 7.0%)
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Those who have hypersensitivity reactions to the IP and its components
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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
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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
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Those who are considered to be ineligible to participate in the clinical study or have difficulty conducting this clinical study by the investigator
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Those subjects with Hb < lower limit of normal (LLN) for males and females
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Those subjects with a platelet count < LLN
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Those subjects with a WBC < LLN
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active EC-18 EC-18 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Proportion of patients alive and free of respiratory failure through at Day 28 28 days
- Secondary Outcome Measures
Name Time Method Probability of progression of mild pneumonia patients to severe pneumonia or ARDS within 28 days 28 days Assessment of all-cause mortality 28 days Respiratory failure defined based on resource utilization requiring at least 1 of the following: 28 days * 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 oxygenationProportion of patients alive and free of invasive mechanical ventilation at a pre-specified timepoint 28 days Proportion of patients with objective measures of improvement (returning to room air) at time points (days 7, 14, and 28) 7, 14, and 28 days Confirmation of changes in subject's subjective clinical symptoms (e.g., patient questionnaire) 28 days o Check for changes in symptoms on a daily basis for 28 days compared to the baseline at day 1
Proportion of patients alive and discharged from the hospital at a pre-specified timepoint 28 days Lengths of ICU stay 28 days Lengths of alive and respiratory failure-free days 28 days
Trial Locations
- Locations (2)
Lincoln Medical Center
🇺🇸Bronx, New York, United States
Kent County Memorial Hospital
🇺🇸Warwick, Rhode Island, United States