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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

Study Description
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Brief Summary:
A trial of EC-18 in patients with mild/moderate pneumonia due to COVID-19

Condition or disease Intervention/treatment Phase
Covid19 Pneumonia Drug: EC-18 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : April 30, 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Active EC-18 Drug: EC-18
2000 mg PO daily
Placebo Comparator: Placebo Drug: Placebo
PO daily


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients alive and free of respiratory failure through at Day 28 [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Probability of progression of mild pneumonia patients to severe pneumonia or ARDS within 28 days [ Time Frame: 28 days ]
  2. Assessment of all-cause mortality [ Time Frame: 28 days ]
  3. 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

  4. Proportion of patients alive and free of invasive mechanical ventilation at a pre-specified timepoint [ Time Frame: 28 days ]
  5. Proportion of patients alive and discharged from the hospital at a pre-specified timepoint [ Time Frame: 28 days ]
  6. Lengths of ICU stay [ Time Frame: 28 days ]
  7. Lengths of alive and respiratory failure-free days [ Time Frame: 28 days ]
  8. 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 ]
  9. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04569227


Contacts
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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

Locations
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United States, New York
Lincoln Medical Center Recruiting
Bronx, New York, United States, 10451
Contact: Maryanne Guerrero         
Principal Investigator: Nail Cemalovic, MD         
United States, Rhode Island
Kent County Memorial Hospital Recruiting
Warwick, Rhode Island, United States, 02886
Contact: Joni Harris         
Principal Investigator: Hadeel Zainah, MD         
Sponsors and Collaborators
Enzychem Lifesciences Corporation
More Information
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Responsible Party: Enzychem Lifesciences Corporation
ClinicalTrials.gov Identifier: NCT04569227    
Other Study ID Numbers: EC-18-204
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: June 10, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia
Infections
Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases