To Evaluate Safety and Efficacy of EC-18 in COVID-19 Infection to Pneumonia
Phase 2, Multi-center, Randomized, Double-blind, Placebo- Controlled Study to Evaluate the Safety and Efficacy of EC-18 in COVID-19 Infection to Pneumonia
1 other identifier
interventional
63
1 country
1
Brief Summary
Prevention of COVID-19 infection to severe pneumonea or ARDS
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 covid19
Started May 2020
1 active site
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
Study Start
First participant enrolled
May 28, 2020
CompletedFirst Submitted
Initial submission to the registry
August 4, 2020
CompletedFirst Posted
Study publicly available on registry
August 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2021
CompletedFebruary 10, 2022
February 1, 2022
8 months
August 4, 2020
February 8, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of transition to ARDS
14 days after starting IP administration
Study Arms (2)
EC-18 Arm
EXPERIMENTALEC-18 QD
Placebo Arm
PLACEBO COMPARATORPlacebo EC-18 QD
Interventions
Eligibility Criteria
You may qualify if:
- Signed informed consent
- Male or female age 19 years or older
- Pathologically confirmed diagnosis of COVID-19 Infection to Pneumonia
You may not qualify if:
- Pathologically confirmed diagnosis of bacterial pneumonia or viral pneumonia
- Pregnant or nursing at the time of signing informed consent
- Known sensitivity to any study medication
- Unwilling or unable to complete study diary
- Any other condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chungbuk National University Hospital
Cheongju-si, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyewon Jeong
Chungbuk National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2020
First Posted
August 5, 2020
Study Start
May 28, 2020
Primary Completion
February 4, 2021
Study Completion
February 15, 2021
Last Updated
February 10, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share