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To Evaluate Safety and Efficacy of EC-18 in COVID-19 Infection to Pneumonia

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
EC-18
Placebo EC-18
Sponsored by
Enzychem Lifesciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed informed consent
  • Male or female age 19 years or older
  • Pathologically confirmed diagnosis of COVID-19 Infection to Pneumonia

Exclusion Criteria:

  • 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

Sites / Locations

  • Chungbuk National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

EC-18 Arm

Placebo Arm

Arm Description

EC-18 QD

Placebo EC-18 QD

Outcomes

Primary Outcome Measures

Rate of transition to ARDS

Secondary Outcome Measures

Full Information

First Posted
August 4, 2020
Last Updated
February 8, 2022
Sponsor
Enzychem Lifesciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04500132
Brief Title
To Evaluate Safety and Efficacy of EC-18 in COVID-19 Infection to Pneumonia
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 28, 2020 (Actual)
Primary Completion Date
February 4, 2021 (Actual)
Study Completion Date
February 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Enzychem Lifesciences Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Prevention of COVID-19 infection to severe pneumonea or ARDS

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EC-18 Arm
Arm Type
Experimental
Arm Description
EC-18 QD
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
Placebo EC-18 QD
Intervention Type
Drug
Intervention Name(s)
EC-18
Intervention Description
EC-18 QD
Intervention Type
Drug
Intervention Name(s)
Placebo EC-18
Intervention Description
Placebo EC-18 QD
Primary Outcome Measure Information:
Title
Rate of transition to ARDS
Time Frame
14 days after starting IP administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent Male or female age 19 years or older Pathologically confirmed diagnosis of COVID-19 Infection to Pneumonia Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyewon Jeong
Organizational Affiliation
Chungbuk National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chungbuk National University Hospital
City
Cheongju-si
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

To Evaluate Safety and Efficacy of EC-18 in COVID-19 Infection to Pneumonia

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