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

• Sponsor: Enzychem Lifesciences Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04500132
• Collaborator: (none)
• Enrollment: 63
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.6
• Patients Per Site Per Month: 7.3

Study Details

Study Description

Brief Summary

Prevention of COVID-19 infection to severe pneumonea or ARDS

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: EC-18; Drug: Placebo EC-18	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 63 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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 COVID-19 Infection to Pneumonia
• Actual Study Start Date: May 28, 2020
• Actual Primary Completion Date: Feb 4, 2021
• Actual Study Completion Date: Feb 15, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Rate of transition to ARDS [14 days after starting IP administration]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chungbuk National University Hospital	Cheongju-si		Korea, Republic of

Sponsors and Collaborators

• Enzychem Lifesciences Corporation

Investigators

• Principal Investigator: Hyewon Jeong, Chungbuk National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Enzychem Lifesciences Corporation
• ClinicalTrials.gov Identifier: NCT04500132
• Other Study ID Numbers: EC-18-C201
• First Posted: Aug 5, 2020
• Last Update Posted: Feb 10, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Pneumonia

Study Results

No Results Posted as of Feb 10, 2022