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

February 8, 2022 updated by: Enzychem Lifesciences Corporation

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

Prevention of COVID-19 infection to severe pneumonea or ARDS

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Cheongju-si, Korea, Republic of
        • Chungbuk National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EC-18 Arm
EC-18 QD
Drug: EC-18
EC-18 QD
Placebo Comparator: Placebo Arm
Placebo EC-18 QD
Drug: Placebo EC-18
Placebo EC-18 QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of transition to ARDS
Time Frame: 14 days after starting IP administration
14 days after starting IP administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Enzychem Lifesciences Corporation

Investigators

  • Principal Investigator: Hyewon Jeong, Chungbuk National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2020

Primary Completion (Actual)

February 4, 2021

Study Completion (Actual)

February 15, 2021

Study Registration Dates

First Submitted

August 4, 2020

First Submitted That Met QC Criteria

August 4, 2020

First Posted (Actual)

August 5, 2020

Study Record Updates

Last Update Posted (Actual)

February 10, 2022

Last Update Submitted That Met QC Criteria

February 8, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC-18-C201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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