Prevention of COVID-19 Infection to Severe Pneumonia or ARDS
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
1 other identifier
interventional
60
1 country
2
Brief Summary
A trial of EC-18 in patients with mild/moderate pneumonia due to COVID-19
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2021
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2020
CompletedFirst Posted
Study publicly available on registry
September 29, 2020
CompletedStudy Start
First participant enrolled
April 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedJune 10, 2021
April 1, 2021
4 months
September 28, 2020
June 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients alive and free of respiratory failure through at Day 28
28 days
Secondary Outcomes (9)
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
Proportion of patients alive and free of invasive mechanical ventilation at a pre-specified timepoint
28 days
Proportion of patients alive and discharged from the hospital at a pre-specified timepoint
28 days
- +4 more secondary outcomes
Study Arms (2)
Active EC-18
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
- 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)
You may not qualify if:
- 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
- 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:
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Lincoln Medical Center
The Bronx, New York, 10451, United States
Kent County Memorial Hospital
Warwick, Rhode Island, 02886, United States
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2020
First Posted
September 29, 2020
Study Start
April 30, 2021
Primary Completion
September 1, 2021
Study Completion
November 1, 2021
Last Updated
June 10, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share