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Prevention of COVID-19 Infection to Severe Pneumonia or ARDS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04569227
Recruitment Status : Recruiting
First Posted : September 29, 2020
Last Update Posted : June 10, 2021
Sponsor:
Information provided by (Responsible Party):
Enzychem Lifesciences Corporation

Tracking Information
First Submitted Date  ICMJE September 28, 2020
First Posted Date  ICMJE September 29, 2020
Last Update Posted Date June 10, 2021
Actual Study Start Date  ICMJE April 30, 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2020)
Proportion of patients alive and free of respiratory failure through at Day 28 [ Time Frame: 28 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2020)
  • Probability of progression of mild pneumonia patients to severe pneumonia or ARDS within 28 days [ Time Frame: 28 days ]
  • Assessment of all-cause mortality [ Time Frame: 28 days ]
  • Respiratory failure defined based on resource utilization requiring at least 1 of the following: [ Time Frame: 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 oxygenation
  • Proportion of patients alive and free of invasive mechanical ventilation at a pre-specified timepoint [ Time Frame: 28 days ]
  • Proportion of patients alive and discharged from the hospital at a pre-specified timepoint [ Time Frame: 28 days ]
  • Lengths of ICU stay [ Time Frame: 28 days ]
  • Lengths of alive and respiratory failure-free days [ Time Frame: 28 days ]
  • Proportion of patients with objective measures of improvement (returning to room air) at time points (days 7, 14, and 28) [ Time Frame: 7, 14, and 28 days ]
  • Confirmation of changes in subject's subjective clinical symptoms (e.g., patient questionnaire) [ Time Frame: 28 days ]
    o Check for changes in symptoms on a daily basis for 28 days compared to the baseline at day 1
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of COVID-19 Infection to Severe Pneumonia or ARDS
Official Title  ICMJE 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Covid19 Pneumonia
Intervention  ICMJE
  • Drug: EC-18
    2000 mg PO daily
  • Drug: Placebo
    PO daily
Study Arms  ICMJE
  • Experimental: Active EC-18
    Intervention: Drug: EC-18
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 28, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: John Choi, M.S. 201-676-3804 john.choi@enzychem.com
Contact: Ji Sun Park, Ph.D. 201-676-3807 jisun.park@enzychem.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04569227
Other Study ID Numbers  ICMJE EC-18-204
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Enzychem Lifesciences Corporation
Study Sponsor  ICMJE Enzychem Lifesciences Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Enzychem Lifesciences Corporation
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP